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Archive of industry news from the global medical industry

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April 2014

Top

Covidien gets USFDA clearance for camera-equipped feeding tube with IRIS technology
15 April 2014 Medical devices manufacturer Covidien has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Kangaroo feeding tube with integrated real-time imaging system...

ROX Medical completes enrolment in device mediated blood pressure therapy study
15 April 2014 US-based ROX Medical has completed the patient enrollment in CONTROL-HTN trial, an international multi-centre, prospective, randomised, controlled, blinded endpoint trial designed to assess...

Edwards Lifesciences wins US sales injunction against Medtronic's CoreValve system
14 April 2014 Edwards Lifesciences has obtained a preliminary injunction from the Federal District Court of Delaware to prevent Medtronic from selling its CoreValve transcatheter aortic valve implantation...

Covidien recalls certain lots of Pipeline and Alligator cerebral aneurysm devices
14 April 2014 Irish firm Covidien has recalled certain lots of its two cerebral aneurysm medical devices, citing risk of stroke or death in patients caused by potential delamination of...

Medtronic’s Evera MRI SureScan ICD system gets CE Mark
11 April 2014 Medtronic has obtained CE Mark approval for its Evera MRI SureScan, an implantable cardioverter-defibrillator (ICD) system designed to allow for full-body MRI scans positioned on any region of...

FDA approves Baxano’s Avance minimally invasive pedicle screw system
11 April 2014 Baxano Surgical has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Avance minimally invasive pedicle screw...

FDA approves Ortho Development’s Ovation Tribute hip stem
10 April 2014 Ortho Development has obtained approval from the US Food and Drug Administration (FDA) for its Ovation Tribute hip stem that is intended for cementless use in total hip replacement...

FDA approves Analogic’s handheld Sonic Window ultrasound system
10 April 2014 US-based Analogic has obtained US Food and Drug Administration (FDA) 510(k) approval for its Sonic Window ultrasound system, a handheld ultra-compact imaging device for visualising vasculature...

Zimmer Spine announces US launch of Optio-C anterior cervical system
09 April 2014 Zimmer Spine has announced the launch of its next-generation Optio-C anterior cervical system in the...

FDA approves GE Healthcare’s Q.Clear technology
09 April 2014 GE Healthcare has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Q.Clear technology that can provide up to two times improvement in both quantitative accuracy...

CardioKinetix reports positive one-year clinical data of Parachute ventricular partitioning device
08 April 2014 CardioKinetix has reported positive results from a pooled analysis study of the first-of-its-kind catheter-based Parachute ventricular partitioning device designed to treat patients with...

St Jude Medical's upgradable spinal cord stimulator gets FDA clearance
08 April 2014 St Jude Medical has obtained US Food and Drug Administration (FDA) approval for its Protégé IPG, an upgradeable neurostimulator designed to assuage chronic pain after traditional treatments...

Edwards Lifesciences obtains CE Mark for its EDWARDS INTUITY Elite Valve System
07 April 2014 US-based Edwards Lifesciences has received CE Mark approval for its next-generation EDWARDS INTUITY Elite valve...

Integra’s Camino Flex Ventricular Catheter gets FDA approval for MRI scans
07 April 2014 Surgical technology developer Integra LifeSciences has obtained US Food and Drug Administration (FDA) approval to use its Camino Flex Ventricular Catheter in magnetic resonance imaging (MRI)...

Cardinal Health to acquire AccessClosure for $320m
04 April 2014 US-based Cardinal Health has signed an agreement worth $320m to acquire AccessClosure, a manufacturer and distributor of extravascular closure...

First US patients receive ICDs in Biotronik’s ProMRI study
04 April 2014 Germany-based Biotronik has announced that the first US patients have received its new Iforia implantable cardioverter-defibrillators...

Intuitive Surgical's da Vinci Xi surgical system receives FDA clearance
03 April 2014 Intuitive Surgical has obtained US Food and Drug Administration (FDA) clearance for its da Vinci Xi System, the next-generation surgical robot designed to replace large-incision abdominal...

Luoxis’ RedoxSYS diagnostic system gets CE Mark approval
03 April 2014 Ampio Pharmaceuticals subsidiary Luoxis Diagnostics has obtained CE Mark approval for its RedoxSYS, a point-of-care diagnostic instrument with accompanying disposable sensors that rapidly...

Sorin's sutureless aortic valve Perceval gets CE Mark approval for new indication
02 April 2014 Sorin Group has obtained an extended CE Mark approval for its sutureless aortic valve Perceval to include patients with aortic stenosis or steno-insufficiency who are younger than 65 years...

Bayer launches new contraceptive Jaydess in UK
02 April 2014 Bayer Healthcare has launched Jaydess, an intrauterine system (IUS) that releases a constant level of levonorgestrel into the uterus, protecting against pregnancy for up to three years with...

FDA approves Analogic’s SonixGPS nerve block needle kit
01 April 2014 Analogic has obtained US Food and Drug Administration’s (FDA) 510(k) approval for its SonixGPS nerve block needle kit, an anesthesia needle kit designed for use with SonixGPS ultrasound...

Medtronic reveals six-month data of first 1,000 patients enrolled in Global Symplicity Registry
01 April 2014 US-based Medtronic has revealed the details of six-month analysis of first 1,000 patients enrolled in the Global Symplicity Registry, the largest renal denervation registry in the...

March 2014

Top

Quidel’s AmpliVue HSV 1+2 Assay gets FDA 510(k) clearance
31 March 2014 Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue HSV 1+2 Assay, the third to launch in the handheld, disposable AmpliVue...

FDA approves Abbott’s Supera peripheral stent system
31 March 2014 Abbott Vascular has obtained approval from US Food and Drug Administration (FDA) for its Supera peripheral stent system, intended for treating patients with blocked blood vessels in the upper...

Medtronic enrols first patients in Improve SCA Clinical Study
28 March 2014 US-based Medtronic has enrolled the first patients in the Improve SCA Clinical Study, a first-of-its-kind study designed to better identify those at major risk of sudden cardiac arrest (SCA)...

Baxter to split into medtech and pharma companies by mid-2015
28 March 2014 US-based Baxter International has revealed its plans to split itself into two separate and independent entities, one focusing on medical products and the other developing and marketing...

GE Healthcare introduces new economical PET/CT system for early cancer detection
27 March 2014 GE Healthcare has introduced Discover IQ, an advanced positron emission tomography/ computed tomography (PET/CT) molecular imaging system designed in India for worldwide...

Shimadzu’s Trinias range of angiography systems gets FDA 510(k) clearance
27 March 2014 Shimadzu Medical Systems USA (Shimadzu) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for Trinias, a new family of digital angiography solutions, comprising...

Acumed announces launch of new pelvic plating system
26 March 2014 US-based Acumed has announced the launch of a new pelvic plating system, marking the company’s entry into the orthopedic implants and instrumentation market for surgical repair of fractures...

Oxford Gene Technology releases latest version of aCGH data analysis software
26 March 2014 Provider of innovative genetics research and biomarker solutions to advance molecular medicine, Oxford Gene Technology (OGT), has released the 4.5.3 version of its CytoSure Interpret...

Benvenue Medical introduces KivaVCF treatment system for spine fractures
25 March 2014 Benvenue Medical has launched its Kiva VCF treatment system, designed for the reduction and treatment of spine...

US FDA approves St Jude Medical’s new pacemakers
25 March 2014 St Jude Medical has obtained US Food and Drug Administration (FDA) approvals for its Allure Quadra cardiac resynchronisation therapy pacemaker (CRT-P) and the Assurity and Endurity...

Medigus obtains FDA 510(k) approval for GERD treatment system
24 March 2014 Israel-based Medigus has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its MUSE system, a minimally invasive treatment device for gastroesophageal reflux disease...

OptiScan Biomedical introduces next-generation bedside glucose monitoring system
24 March 2014 OptiScan Biomedical has launched its OptiScanner 6000, a next-generation continuous monitoring platform for intensive care...

St. Jude Medical’s Prodigy chronic pain neurostimulator gets CE mark
21 March 2014 St. Jude Medical has received the CE Mark approval for its Prodigy chronic pain system with Burst Technology and is now launching the system in...

Cochlear obtains FDA approval for Nucleus Hybrid L24 Cochlear implant system
21 March 2014 Australia-based Cochlear has obtained US Food and Drug Administration (FDA) approval for its Nucleus Hybrid L24 Cochlear implant system, which combines the functions of a cochlear implant and...

NIRF Imaging and Exelis form diagnostic technology alliance
20 March 2014 US-based NIRF Imaging and Exelis have joined forces to develop and market a near-infrared fluorescence imaging technology for point-of-care diagnostic...

Medrobotics gets CE Mark approval for first robot-assisted flexible endoscopic system
20 March 2014 Medrobotics has received CE Mark approval for its Flex system, a robotic-assist platform that enables surgeons to gain single-site access and visualisation to difficult-to-access anatomical...

Bard enrols first US patient in Lutonix ISR trial
19 March 2014 CR Bard has enrolled the first patient in its Lutonix In-Stent Restenosis (ISR) clinical trial, a pivotal multi-centre randomised investigational device exemption (IDE) study in the...

St Jude Medical begins post-approval Nanostim trial in Europe
19 March 2014 St Jude Medical has announced the first enrolments in its European LEADLESS pacemaker observational study, designed to build additional evidence to support the safety profile of the...

eZono obtains FDA 510(k) approval for eZono 4000 tablet ultrasound system with eZGuide
18 March 2014 Tablet ultrasound systems developer eZono has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its eZono 4000 dedicated procedural guidance system with eZGuide...

BioCardia’s Morph AccessPro steerable introducer receives CE Mark approval
18 March 2014 BioCardia has received CE Mark approval for its Morph AccessPro steerable introducer, designed for easier navigation through the vasculature during delivery of biotherapeutics and medical...

Covidien announces US launch of new hernia repair product
17 March 2014 Irish medical device company Covidien has announced the launch of its Symbotex composite mesh in the US for surgical laparoscopic and open ventral hernia...

Biotronik obtains FDA clearance to expand ProMRI clinical trial
17 March 2014 German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI...

USFDA panel recommends Roche’s HPV test as primary screening tool for cervical cancer
14 March 2014 The US Food and Drug Administration (FDA) advisory committee unanimously recommended Roche's cobas HPV (Human Papillomavirus) test as a first-line primary screening tool in women 25 years and...

Boston Scientific’s REBEL platinum chromium coronary stent system gets CE Mark approval
14 March 2014 US-based Boston Scientific has received CE Mark approval for its next-generation bare metal stent, REBEL platinum chromium coronary stent system, designed to treat coronary artery disease...

RTI Surgical’s Fortiva porcine dermis obtains CE Mark approval
13 March 2014 RTI Surgical has received CE Mark approval for its Fortiva porcine dermis, a ready-to-use biologic implant that acts as a scaffold allowing for neovascularisation and permitting replacement of...

First migraine prevention device gets FDA approval
13 March 2014 Belgium-based Cefaly Technology has obtained US Food and Drug Administration (FDA) approval for its device for preventative treatment of migraine...

Researchers develop system to use smartphones to diagnose diseases in real-time
12 March 2014 Researchers at the University of Houston in the US are developing a disease diagnostic system to use smartphones for diagnosing diseases in real-time, offering results that could be read using...

AngioDynamics’ AngioVac cannula gets FDA clearance for expanded indication
12 March 2014 Provider of minimally invasive medical devices used in image-guided procedures, AngioDynamics has obtained US Food and Drug Administration (FDA) approval for an expanded indication for its...

Cardiovascular Systems gets FDA clearance for low profile Diamondback atherectomy system
11 March 2014 Cardiovascular Systems has obtained US Food and Drug Administration (FDA) clearance for a new size of its Diamondback 360 peripheral orbital atherectomy system (OAS), designed for...

Mainstay Medical gets Australian approval for clinical study of implantable neurostimulation device
11 March 2014 Mainstay Medical has obtained clearance from Ethics Committees in Australia to initiate a clinical trial of ReActiv8, an implantable neurostimulation device for treatment of people with chronic...

Sealantis reports positive results from protein-free bioresorbable sealant trial
10 March 2014 Israel-based developer of protein-free alga-mimetic tissue adhesives, Sealantis, has reported positive results from its first prospective, single-arm, non-randomised clinical study that tested...

FDA grants clearance for AngioDynamics’ DuraMax dialysis catheter with BioFlo technology
10 March 2014 AngioDynamics has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its BioFlo DuraMax chronic haemodialysis catheter, designed for use in attaining long-term...

European Patent Office revokes Edwards' Spenser patent
07 March 2014 US-based Medtronic has announced that the European Patent Office (EPO) has invalidated an Edwards’ patent (EP2055266) that was used to prevent Medtronic from selling its CoreValve...

Mauna Kea Technologies’ Cellvizio obtains FDA 510(k) clearance for use in urology
07 March 2014 French device maker Mauna Kea Technologies has obtained a 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for Cellvizio in the field of...

Biotronik's ultra-tiny MRI-safe CRT lead obtains CE Mark clearance
06 March 2014 Manufacturer of technology specialising in heart failure therapy, Biotronik, has announced the European approval and the first implantations of its bipolar cardiac resynchronisation therapy...

Blockade Medical wins US and European clearances for two new additions to Barricade Coil system
06 March 2014 Blockade Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) and European CE Mark for two additions to the Barricade Coil system, with enhanced framing and...

Staar Surgical’s Visian ICL with CentraFLOW technology wins Japanese approval
05 March 2014 US firm Staar Surgical has obtained regulatory clearance from the Japanese Ministry of Health, Labour and Welfare to market its Visian implantable collamer lens (ICL) with CentraFLOW...

Biodesix’s VeriStrat test for lung cancer treatment obtains CE Mark approval
05 March 2014 US-based Biodesix has secured CE Mark approval for its VeriStrat specimen collection and shipping kit, a blood-based protein diagnostic that predicts differential treatment outcomes for...

PerkinElmer launches Lamina scanner for clearer visualisation of protein biomarker
04 March 2014 PerkinElmer has launched its Lamina multilabel slide scanner, a new high throughput imaging system designed to assist research pathologists to more easily study protein expression and...

Covidien obtains CE Mark approval for next generation acute ventilation system
04 March 2014 Covidien has received European Economic Area (EEA) CE Mark approval for its Puritan Bennett 980 ventilator, designed to deliver advanced breath technology with enhanced patient comfort...

One year follow-up data from European study confirms durability of Sapheon’s VenaSeal closure system
03 March 2014 Sapheon has reported one year follow-up data from its European multicentre clinical study of the VenaSeal sapheon closure system, an advanced approach to the treatment of venous reflux...

Covidien closes acquisition of Given Imaging
03 March 2014 Medical devices manufacturer Covidien has closed its $860m buyout of the Israeli company Given Imaging, providing the company additional scale and scope to serve a significant medical specialty...

February 2014

Top

Qiagen introduces new HPV test in India
28 February 2014 Qiagen has rolled-out its careHPV Test, a new molecular diagnostic test for high-risk human papillomavirus (HPV), in...

Imris obtains Australian approval for intraoperative CT solution
28 February 2014 Imris has obtained Therapeutic Goods Administration (TGA) regulatory listing for its ceiling-mounted Visius intraoperative computed tomography...

OrbusNeich begins joint US and Japanese registration study for Combo dual therapy stent
27 February 2014 Hong Kong-based OrbusNeich has initiated patient enrolment in the HARMONEE study being conducted for evaluating the Combo dual-therapy stent, designed to address the challenges of delayed...

Covidien receives FDA 510(k) clearance for Puritan Bennett 980 ventilator
27 February 2014 Covidien has obtained US Food and Drug Administration (FDA) 510(k) clearance for its Puritan Bennett 980 ventilator, the new acute care ventilator that delivers advanced breath technology...

Biosense Webster obtains FDA clearance for new catheter featuring contact force-sensing technology
26 February 2014 Johnson & Johnson subsidiary Biosense Webster has received approval from the US Food and Drug Administration (FDA) for its ThermoCool SmartTouch force-sensing ablation catheter, designed...

BSD Medical announces Taiwanese regulatory clearance for BSD-2000 hyperthermia system
26 February 2014 Provider of medical systems that use heat therapy to treat cancer, BSD Medical, has announced that its exclusive Taiwanese distributor, Linden Bioscience (Linden), has obtained Taiwan Food and...

Paragonix’s Sherpa cardiac transport system obtains second FDA 510(k) clearance
25 February 2014 Paragonix Technologies has received clearance for its second Premarket Notification (510(k)) from the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak cardiac transport system...

J&J's Cordis obtains CE Mark for Renlane renal denervation device
25 February 2014 Johnson & Johnson subsidiary Cordis has obtained the European CE Mark for its Renlane renal denervation system designed for the treatment of adult patients (>18 years) with...

Cyberonics receives CE Mark approval for its sixth-generation VNS Therapy generator
24 February 2014 Cyberonics has obtained the CE Mark approval for AspireSR, its novel sixth-generation VNS Therapy generator designed to analyse relative heart rate changes to detect and respond to...

Stryker launches second generation fully visible stent retriever to treat acute ischemic stroke
24 February 2014 Stryker has announced the global commercial launch of its new Trevo XP ProVue retriever, the second generation fully visible stent retriever designed to treat acute ischemic...

Cook Medical launches Biodesign duraplasty graft for dura mater repair
21 February 2014 Cook Medical has introduced Biodesign duraplasty graft, a new treatment option designed for otolaryngologists (ear, nose and throat specialists) who repair the dura mater following...

Medtronic reports first implant of vitamin-sized leadless pacemaker in US
21 February 2014 Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in the US, as part of the company's single-arm, multi-centre global clinical...

Mardil Medical completes first human implants of new ventricular reshaping device
20 February 2014 US-based Mardil Medical has completed the first human implants of its VenTouch ventricular reshaping device, a new treatment option for functional mitral valve regurgitation (FMR), at the...

Medtronic launches Reveal LINQ insertable cardiac monitor system
20 February 2014 Medtronic has announced the worldwide launch of its Reveal LINQ insertable cardiac monitor (ICM) system, the smallest implantable cardiac monitoring device available for...

Claret Medical obtains FDA’s IDE approval to begin US pivotal trial of Sentinel cerebral protection system
19 February 2014 Claret Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a multicentre study of its Sentinel Cerebral Protection...

BioFire seeks FDA clearance for FilmArray gastrointestinal panel
19 February 2014 BioFire Diagnostics has submitted 510(k) application to the US Food and Drug Administration (FDA) seeking clearance for its FilmArray gastrointestinal (GI) panel, a comprehensive 23-target...

Boston Scientific’s fully covered esophageal metal stent gets CE Mark
18 February 2014 US-based Boston Scientific has received CE Mark in Europe for its WallFlex esophageal fully covered stent, designed to treat refractory benign esophageal strictures, a narrowing of the...

BD Diagnostics gets CE-IVD Mark for BD Onclarity HPV assay on BD Viper LT system
18 February 2014 BD Diagnostics has achieved CE/IVD marking for the BD Onclarity HPV assay on the new BD Viper LT...

Medtronic launches new catheter to treat lower extremity blockages in Europe
17 February 2014 Medtronic has launched the TOTAL across crossing catheter, a new peripheral angioplasty balloon technology designed to help improve blood flow in narrowed or occluded lower-extremity...

IMRIS’s next-generation VISIUS surgical theatre gets FDA clearance
17 February 2014 IMRIS has received the US Food and Drug Administration (FDA) clearance for its next- generation VISIUS surgical theatre equipped with Siemens' latest high-field MR...

Tryton Medical’s side branch stent receives CE Mark for left main indication
14 February 2014 US-based Tryton Medical has received CE Mark for its side-branch stent for the treatment of left main coronary artery...

Fujitsu Laboratories and imec Holst Centre develop wireless transceiver circuit for use in body area networks
14 February 2014 Fujitsu Laboratories and Holst Centre, a European R&D initiative by imec (Belgium), have developed low-power wireless transceiver circuit for use in body area networks (BAN) for potential...

Cook Medical launches first endobronchial ultrasound needle in US
13 February 2014 Cook Medical has released a new endobronchial ultrasound (EBUS) needle, a single-use, disposable item for fine-needle biopsy (FNB) intended for sampling of submucosal and extramural lesions...

DEKA Medical’s aesthetic laser gets FDA clearance for variety of cosmetic procedures
13 February 2014 US-based DEKA Medical has recently received clearance from the US Food and Drug Administration (FDA) for its Synchro REPLA: Y laser, designed for a variety of aesthetic...

Hansen Medical obtains FDA clearance for new robotic catheter for peripheral vascular interventions
12 February 2014 US-based Hansen Medical has obtained the US Food and Drug Administration (FDA) clearance for its smaller diameter Magellan 6Fr robotic catheter, designed for peripheral vascular...

Harvard and MIT researchers develop new hearing aid chip
12 February 2014 Researchers from Massachusetts Eye and Ear Infirmary (MEEI), Harvard Medical School, and Massachusetts Institute of Technology (MIT) have designed a new, low-power signal-processing...

Admedus gets US FDA clearance for new regenerative tissue product
11 February 2014 Australia-based Admedus has received US Food and Drug Administration (FDA) clearance to market CardioCel, an advanced cardiovascular scaffold designed to repair and treat a range of...

Xerox launches remote healthcare sensing research project in US and India
11 February 2014 Xerox researchers have designed a new medical technology that uses video cameras and data analytics to monitor a patient’s condition without wires, discomfort or risk of...

Nipro Medical launches Elisio Polynephron dialyzer in US
10 February 2014 US-based Nipro Medical has announced the launch of its Elisio Polynephron dialyser, designed for the renal market, targeting those involved in care and procedures for kidney disease and...

St Jude Medical implants Nanostim leadless cardiac pacemaker in first US patient
10 February 2014 St Jude Medical has announced the first US implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim leadless pacemaker for US Food and Drug Administration (FDA)...

Edwards gets CE Mark for transcatheter mitral and aortic valve-in-valve
07 February 2014 US-based Edwards Lifesciences has received CE Mark approval in Europe to market its next-generation Sapien XT transcatheter heart valve system for either mitral or aortic valve-in-valve...

Medtronic announces European launch of new generation Enlite sensor
07 February 2014 Medtronic has launched its new generation Enlite sensor, designed to provide a more consistent and comfortable experience for people using continuous glucose monitoring (CGM) in...

Hologic’s Aptima HPV assay gains Health Canada approval for use on Panther system
06 February 2014 Diagnostic and medical imaging systems provider Hologic has received Health Canada approval for use of its Aptima HPV 16 18/45 genotype assay on the company's fully automated Panther...

Boston Scientific introduces OffRoad re-entry catheter system in US
06 February 2014 US-based Boston Scientific has introduced the OffRoad re-entry catheter system in the US and reported the first successful use of the device to bypass a total occlusion in peripheral leg...

Thermo Fisher completes $13.6bn Life Tech acquisition
05 February 2014 Thermo Fisher Scientific has completed its acquisition of Life Technologies, a life sciences company, for approximately $13.6bn and the assumption of $1.5bn in net...

FDA approves Dexcom's G4 Platinum CGM system for use in paediatric population
05 February 2014 Dexcom has received the US Food and Drug Administration (FDA) approval for its continuous glucose monitoring device, Dexcom G4 Platinum (Paediatric) for use in children aged between two and...

Smith & Nephew to buy ArthroCare for $1.7bn
04 February 2014 Smith & Nephew has agreed to buy ArthroCare for $48.25 per ArthroCare share in cash, a total consideration of approximately $1.7bn and an enterprise value of $1.5bn, as part of its strategy...

Virtus Health Services introduces oral cancer test in India
04 February 2014 Virtus Health Services India has introduced the O-Test, a low-cost early stage detection test for oral...

Given Imaging obtains FDA clearance for PillCam COLON video capsule
03 February 2014 Given Imaging has obtained US Food and Drug Administration (FDA) clearance under the direct de novo classification for its PillCam COLON, designed to assist physicians and patients who are...

Physio-Control signs merger agreement with Sansio
03 February 2014 US-based Physio-Control has entered into a merger agreement with Sansio, a provider of software-as-a-service (SaaS) solutions for the emergency medical services (EMS) and home medical...

January 2014

Top

Wright Medical acquires Solana Surgical and OrthoPro
31 January 2014 Wright Medical Group has acquired Solana Surgical (Solana) and entered into a definitive agreement to acquire OrthoPro, provider of foot and ankle...

Ulthera obtains third FDA clearance for its ultrasound platform device
31 January 2014 US-based Ulthera has obtained the US Food and Drug Administration (FDA) approval for its Ulthera system to visualise the dermal and subdermal layers of tissue during the non-invasive...

BioControl Medical obtains Israeli approval for clinical study of CardioFit system
30 January 2014 BioControl Medical has received approval from the Israel Ministry of Health to initiate a clinical study of its CardioFit system in patients with chronic heart failure (HF) as part of...

FDA approves Medtronic’s Valiant Captivia system for type B aortic dissections
30 January 2014 Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Valiant Captivia thoracic stent graft system for the treatment of type B aortic...

Health Canada approves Sapheon’s VenaSeal sapheon closure system
29 January 2014 US-based Sapheon has obtained Health Canada approval for its VenaSeal sapheon closure system, designed to treat venous reflux disease (varicose...

FDA approves Benvenue’s new Kiva implant for treatment of spinal fractures
29 January 2014 Benvenue Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal...

St Jude Medical announces post-approval implant of Nanostim pacemaker in UK
28 January 2014 US-based medical device company St Jude Medical has announced the first post-approval implant of the Nanostim leadless pacemaker at St Bartholomew’s Hospital in the...

Edwards Lifesciences obtains CE Mark for Sapien 3 transcatheter aortic valve
28 January 2014 US-based Edwards Lifesciences has obtained CE Mark approval in Europe for Sapien 3 valve, the latest in its line of Sapien transcatheter aortic valve implantation...

Masimo receives CE Mark approval for O3 regional oximetry
27 January 2014 US-based Masimo has received CE Mark approval for O3 regional oximetry for use with its Root patient monitoring and connectivity platform. It is designed to assist clinicians...

FDA approves Miltenyi Biotec’s CliniMACS CD34 reagent system
27 January 2014 Miltenyi Biotec has obtained approval from the US Food and Drug Administration (FDA) for its CliniMACS CD34 reagent system for prevention of graft-versus-host disease (GVHD) in the treatment...

Pressure Products gets FDA approval for SafeSept needle free transseptal guidewire
24 January 2014 US-based Pressure Products has obtained the US Food and Drug Administration (FDA) clearance for its SafeSept needle free transseptal guidewire, designed for use with any introducer system...

Medtronic obtains FDA clearance for full-body MRI with SureScan pacing systems
24 January 2014 US-based Medtronic has obtained expanded approval from the US Food and Drug Administration (FDA) for its SureScan pacing systems, which have been branded safe for magnetic resonance imaging...

Covidien obtains FDA 510(k) clearance for its LigaSure laparoscopic surgical device
23 January 2014 Covidien has received the US Food and Drug Administration (FDA) 510(k) clearance for the LigaSure Maryland jaw open/laparoscopic sealer/divider, designed to improve efficiency during...

Cordis reports positive three-year results from STROLL trial
23 January 2014 Johnson & Johnson subsidiary Cordis has presented promising results from the three-year STROLL study at the Abstracts and Late Breaking Clinical Trials session at the 26th Annual...

Endologix begins enrolment in clinical study of Nellix EVAS System
22 January 2014 Endologix has announced the enrolment of the first patient in the EVAS FORWARD-IDE clinical trial, designed to assess the safety and effectiveness of its Nellix endovascular aneurysm sealing...

Vascular Solutions introduces ThrombiDisc topical hemostat in US
22 January 2014 Vascular Solutions has launched ThrombiDisc topical hemostat, a pad designed to control surface bleeding from vascular access sites and percutaneous catheters or...

Myriad Genetics, Sividon Diagnostics enter into co-marketing agreement for EndoPredict
21 January 2014 US-based Myriad Genetics and Germany-based Sividon Diagnostics have announced an exclusive co-marketing agreement for the sales and marketing of Sividon's EndoPredict test, a multigene...

Novo Nordisk introduces NovoFine plus pen needle in Canada
21 January 2014 Novo Nordisk has introduced NovoFine plus 32G 4mm, an ultra-thin, ultra-short pen needle that aims to make injections more comfortable for patients with...

Medtronic obtains US FDA approval for CoreValve implant
20 January 2014 US-based Medtronic has received the US Food and Drug Administration (FDA) approval for its self-expanding transcatheter CoreValve system, designed for severe aortic stenosis patients who are...

FDA approves Affymetrix’s new post-natal test to help diagnose child’s developmental delay or intellectual disability
20 January 2014 US-based Affymetrix has obtained the US Food and Drug Administration clearance to market its CytoScan Dx assay, designed to detect chromosomal variations that may be responsible for a...

Elixir Medical reports first commercial implant of DESolve scaffold system in Europe
17 January 2014 Elixir Medical has announced the first commercial implant of CE Mark-approved DESolve Novolimus Eluting Coronary Scaffold, designed to degrade in 12 months and returning the patients'...

Carlyle Group to buy Johnson & Johnson's diagnostic unit for $4.15bn
17 January 2014 The Carlyle Group has agreed to buy Johnson & Johnson's Ortho-Clinical Diagnostics (OCD) business for $4.15bn....

Health Canada grants marketing licence to EndoChoice's Fuse endoscopy system
16 January 2014 US-based medical device company EndoChoice has obtained a marketing licence from Health Canada for its Fuse Full Spectrum Endoscopy...

Varian Medical Systems' updated ProBeam proton therapy system obtains FDA approval
16 January 2014 US-based radiation therapy firm Varian Medical Systems has obtained US Food and Drug Administration (FDA) 510(k) clearance for its updated ProBeam proton therapy...

FDA approves Excelsior Medical’s SwabCap disinfection cap
15 January 2014 US-based Excelsior Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its SwabCap luer access valve disinfection cap line of...

Acumed introduces new screw system for ligament repair
15 January 2014 Acumed has launched its scapho-lunate inter carpal (SLIC) screw system for stabilising bones during the repair and healing of the scapho-lunate interosseous...

BioCardia gets approval for Helix 953L catheter in EU
14 January 2014 BioCardia has obtained CE Mark approval in the EU for its Helix 953L catheter as part of its Helix transendocardial delivery system for infusion of biologics to the...

MediValve obtains FDA approval for acWire guidewire
14 January 2014 MediValve has obtained 510(k) pre-marketing clearance from the US Food and Drug Administration for its acWire guidewire, intended for use in peripheral vascular and heart...

Medtronic's Symplicity HTN-3 renal denervation study fails to meet primary efficacy endpoint
13 January 2014 US-based Medtronic has announced that the Symplicity HTN-3 clinical trial evaluating the use of its renal denervation system in patients with treatment-resistant hypertension has failed to meet...

Ocular Therapeutix obtains FDA clearance for ReSure sealant
13 January 2014 Ocular Therapeutix has obtained approval from the US Food and Drug Administration (FDA) for its ReSure sealant, indicated for prevention of postoperative fluid egress from incisions with...

MediValve receives European pre-market clearance for acWire guidewire
10 January 2014 The Trendlines Group's portfolio company MediValve has received CE Mark clearance for its acWire guidewire, to facilitate the accurate placement and alignment of medical devices in...

Cardica obtains FDA clearance for MicroCutter Xchange 30 cutting/stapling device
10 January 2014 US-based medical device company Cardica has received 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroCutter Xchange 30 cutting/stapling device and blue staple...

Roche launches cobas MRSA/SA test in Europe
09 January 2014 Roche has launched the cobas MRSA/SA test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) from...

K2M obtains FDA 510(k) approval for Cayman minimally invasive system
09 January 2014 Spinal device manufacturer K2M has received 510(k) approval from the US Food and Drug Administration (FDA) for its Cayman minimally invasive (MI)...

Sapheon submits second 'PMA' module for VenaSeal closure system
08 January 2014 US-based Sapheon has submitted the second module of the pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for VenaSeal sapheon closure system, designed for...

LabStyle Innovations seeks marketing clearance for Dario blood glucose monitoring system in US
08 January 2014 Israel-based LabStyle Innovations has filed a premarket notification application, also known as a 510(k), with the US Food and Drug Administration (FDA) for the Dario blood glucose monitoring...

Topera gets FDA 510(k) approval for 3D mapping system
07 January 2014 US-based medical device company Topera has announced that the US Food and Drug Administration (FDA) has granted 510(k) approval for the company's third-generation 3D mapping...

Medtronic enrols first patient in VICTORY AF clinical trial
07 January 2014 US-based Medtronic has enrolled the first patient in the VICTORY AF clinical trial to assess its Phased RF system, designed to eliminate or block abnormal electrical impulses in the left...

Smiths Medical gets FDA clearance for latest CADD-Solis pain management system
06 January 2014 Smiths Medical has obtained the US Food and Drug Administration (FDA) 510(k) clearance to market its CADD-Solis pain management system version 3.0 with programmed intermittent bolus (PIB)...

InVivo Therapeutics sends revised protocol to FDA for spinal cord device clinical study
06 January 2014 InVivo Therapeutics has sent the revised protocol and related study documents to the US Food and Drug Administration (FDA) for conducting a clinical trial designed to measure the safety of...

Stryker to acquire Patient Safety Technologies for $120m
03 January 2014 US-based Stryker has signed a definitive agreement to acquire Patient Safety Technologies in an all cash transaction for $2.22 per common share, with a total transaction value of...

CareFusion closes $500m acquisition of Vital Signs from GE Healthcare
03 January 2014 CareFusion has completed the acquisition of the Vital Signs division from GE Healthcare in the US, China and other specific...

Quidel's Group B Streptococcus assay gets FDA clearance
02 January 2014 Quidel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its AmpliVue Group B Strep Assay, the second to launch in the handheld, disposable AmpliVue...

Placebo knee surgery is as effective as many keyhole procedures, says study
02 January 2014 A study carried out at the University of Helsinki has found that repairing meniscal cartilage in the knee is often no more effective than a placebo, and around 10,000 surgeries performed...

December 2013

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Ziehm Imaging obtains FDA approval for Ziehm Vision RFD hybrid edition
24 December 2013 Ziehm Imaging has obtained marketing clearance from the US Food and Drug Administration (FDA) for its high-end motorised mobile C-arm Ziehm Vision RFD hybrid...

Miraculins initiates process for seeking US marketing clearance for Scout DS system
24 December 2013 Medical diagnostic company Miraculins has filed pre-submission documentation with the US Food and Drug Administration (FDA) for the US marketing approval of its Scout DS system, a non-invasive...

Baxter obtains CE Mark approval for Vivia haemodialysis system
23 December 2013 Baxter International has gained CE mark approval for its Vivia haemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home high dose (HD)...

Endologix receives FDA IDE approval for evaluation of Nellix EVAS system
23 December 2013 Endologix has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate a multi-centre study for assessing the safety and...

Xlumena obtains FDA approval for Axios pancreatic stent
20 December 2013 Xlumena has obtained the US Food and Drug Administration (FDA) approval to market its Axios stent and delivery system, through the FDA's less-stringent de novo review...

Philips’ breast density measurement application gets FDA clearance
20 December 2013 Royal Philips has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the spectral breast density measurement application for use with its MicroDose SI full-field...

Oticon Medical obtains FDA 510(k) approval for Ponto Plus bone anchored sound processors
19 December 2013 Sweden-based Oticon Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its new Ponto Plus bone anchored sound...

Boston Scientific gets CE Mark approval for X4 quadripolar CRT-D systems
19 December 2013 US-based Boston Scientific has received CE Mark approval for its next-generation X4 line of quadripolar cardiac resynchronisation therapy defibrillator (CDT-D) systems, designed to advance...

Medtronic randomises first patients in first US renal denervation clinical study
18 December 2013 Medtronic has reported that the first patients have been randomised in Symplicity HTN-4, the first randomised clinical trial to investigate renal denervation for the treatment of...

NuVasive launches ALIF column realignment procedure in US
18 December 2013 Minimally disruptive surgical products manufacturer NuVasive has launched its ALIF ACR in the US, the device is an anterior column realignment procedure for anterior lumbar interbody...

US engineers develop new smartphone app to check cholesterol levels
17 December 2013 Cornell University engineers have developed a new lifesaving app using sophisticated camera technology that will help smartphone users quickly check their cholesterol levels in around a...

Valeant Pharmaceuticals to buy Solta Medical for $250m
17 December 2013 Valeant Pharmaceuticals International intends to acquire Solta Medical, a US-based developer of energy-based medical devices for aesthetic applications, for approximately...

eNeura Therapeutics’ Cerena TMS gets FDA clearance for migraine treatment
16 December 2013 The US Food and Drug Administration (FDA) issued a marketing clearance for eNeura Therapeutics' Cerena transcranial magnetic stimulator (TMS), a device designed to relieve pain caused by...

Ventana announces HER2 companion diagnostic assay for Perjeta and Kadcyla
16 December 2013 Roche Group’s Ventana Medical Systems (Ventana) has announced the Ventana HER2/neu (4B5) rabbit monoclonal primary antibody assay as a companion diagnostic for detecting HER2 protein expression...

Ethicon obtains FDA 510(k) clearance for new shears with adaptive tissue technology
13 December 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ethicon Endo-Surgery's new Harmonic Focus+ shears with adaptive tissue technology, a next-generation ultrasonic...

St Jude Medical obtains European approval for 25mm Portico transcatheter aortic heart valve
13 December 2013 Medical technology developer St Jude Medical has obtained CE Mark approval for its 25mm Portico transcatheter aortic heart valve implantation system, designed to treat patients with severe...

Surefire Medical completes patient enrolment in COSY clinical trial
12 December 2013 US-based developer of cancer-drug delivery catheters Surefire Medical has completed enrolment in COSY, the randomised prospective study designed to determine the safest method of...

Gore’s Viabahn endoprosthesis gets FDA expanded approval for revision of AV access
12 December 2013 W L Gore & Associates (Gore) has obtained the expanded approval from the US Food and Drug Administration (FDA) for its Viabahn endoprosthesis to treat stenosis or thrombotic occlusion at the...

Philips introduces new gel pillows mask for sleep apnoea patients
11 December 2013 Philips Respironics, a unit of Royal Philips, has introduced a new gel pillows mask called Nuance, which is designed to comfortably seal at the opening of the nose and help improve therapy...

Medtronic reports first implant of miniature transcatheter pacemaker system in Austria
11 December 2013 US-based Medtronic has announced that its Micra transcatheter pacing system (TPS) has been implanted in the first patient in Linz, Austria, as part of the company's single-arm, multi-centre...

American Medical Systems obtains FDA 510(k) clearance for RetroArc retropubic sling system
10 December 2013 American Medical Systems, a subsidiary of Endo Health Solutions, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its RetroArc retropubic sling...

SetPoint Medical selects Sagentia as development partner for new neuromodulation device
10 December 2013 US-based SetPoint Medical has selected Sagentia as a development partner for its neuromodulation device indicated for chronic inflammatory...

Jarvik Heart obtains regulatory clearance for Jarvik 2000 Heart in Japan
09 December 2013 Jarvik Heart has obtained regulatory approval for its Jarvik 2000 Heart, a left ventricular assist device (LVAD) implanted inside the heart, from the Japanese Pharmaceuticals and Medical...

Sorin obtains CE Mark approval for Intensia family of ICD and CRT-D devices
09 December 2013 Italy-based medical device company Sorin has obtained CE Mark approval for Intensia family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT-D)...

TYRX obtains FDA approval for antibacterial envelope for use with spinal cord neuromodulators
06 December 2013 TYRX has secured clearance from the US Food and Drug Administration (FDA) to sell its AIGISRx N, an antibacterial mesh envelope that can be used with spinal cord...

Medtronic receives approval for next-generation renal denervation system in EU and Australia
06 December 2013 Medtronic has obtained approval in the Europe and Australia to market its next-generation components of Symplicity renal denervation system, designed to reduce ablation time and provide ease...

NEC Display Solutions obtains FDA 510(k) clearance for MD242C2 medical diagnostic monitor
05 December 2013 NEC Display Solutions of America has obtained the Food and Drug Administration (FDA) 510(k) market clearance for its 24in MultiSync MD242C2 referral-grade, widescreen display, designed for...

Oculus obtains FDA clearance for Microcyn scar management hydrogel
05 December 2013 US-based developer of wound care devices Oculus Innovative Sciences has obtained a new 510(k) clearance from the US Food and Drug Administration (FDA) for its new Microcyn scar management...

Sense4Baby obtains 510(k) and CE Mark approval for foetal monitoring system
04 December 2013 US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) and CE Mark approval from the European Commission for its smartphone-based foetal monitoring...

St Jude Medical begins Prodigy neurostimulator trial for chronic pain
03 December 2013 US-based medical technology developer St Jude Medical has started a clinical study of new Prodigy neurostimulator for assessing whether burst stimulation can be more effective in managing...

GE’s new Revolution CT system captures motion free image of heart
02 December 2013 GE Healthcare has announced that its new Revolution CT system has captured a motion free image of the human heart in just one beat with uncompromised image...

Gore obtains Japanese approval for Gore C3 delivery system
02 December 2013 W L Gore & Associates (Gore) has obtained Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the Gore Excluder AAA endoprosthesis, comprising the new Gore C3...

Pentax Medical to commercialise Smart Medical Systems' G-Eye endoscope in EMEA
02 December 2013 Developer of endoscopic imaging devices Pentax Medical has agreed to commercialise Smart Medical Systems' G-Eye endoscope in Europe, the Middle East and Africa under a new strategic...

HeartWare acquires CircuLite for $30m
02 December 2013 US-based HeartWare International has acquired CircuLite, a developer of the Synergy circulatory support system, designed to treat less sick, ambulatory, chronic heart failure patients who are...

November 2013

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US researchers achieve breakthrough in nanomedicine
29 November 2013 Researchers at Brigham and Women's Hospital and Massachusetts Institute of Technology have achieved a breakthrough in nanomedicine by developing a new type of nanoparticle, which can...

BME receives FDA clearance for upgraded HammerLock intramedullary fixation system
29 November 2013 Orthopaedics specialists BioMedical Enterprises (BME) has received the US Food and Drug Administration (FDA) approval for its upgraded HammerLock Nitinol intramedullary fixation system...

Sorin obtains CE Mark approval for new MRI compatible pacing system
28 November 2013 Sorin Group has obtained CE Mark approval for its KORA 100 pacing system, a new magnetic resonance imaging (MRI) compatible...

Smith & Nephew to acquire distribution of its wound care business in Brazil
28 November 2013 Smith & Nephew has signed an agreement with Politec Saúde to acquire the Brazilian distribution of its wound care products for an undisclosed...

Medtronic's Endurant II AAA stent graft demonstrates long-term durability and consistent outcomes
27 November 2013 Medtronic has reported positive findings from the ongoing global endurant stent graft natural selection global postmarket (ENGAGE) registry of patients treated with the company's Endurant II...

Echo Therapeutics to submit CE Mark technical file for Symphony CGM system
27 November 2013 Echo Therapeutics has reported positive results from its multi-centre clinical trial of the Symphony CGM system for non-invasive, wireless continuous glucose monitoring in surgical patients...

Sorin obtains CE Mark approval for XL version of Perceval sutureless aortic valve
26 November 2013 Sorin Group has received CE Mark approval for the XL version of Perceval, a sutureless biological valve indicated for the rapid and minimally invasive surgical replacement of the aortic valve...

Boston Scientific obtains FDA clearance for next-generation Promus Premier coronary stent
26 November 2013 Boston Scientific has obtained US Food and Drug Administration (FDA) approval for the Promus Premier everolimus-eluting platinum chromium coronary stent system, the company's...

Sorin obtains CE mark approval for new stentless pericardial heart valve
25 November 2013 Sorin Group has received CE Mark approval for the Solo Smart stentless aortic valve, a unique bioprosthesis designed to replace the aortic valve without leaving a stent in...

EMA panel recommends NovoRapid PumpCart insulin pump
25 November 2013 The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended clearance of Denmark-based company Novo Nordisk's NovoRapid PumpCart in...

Biotronik obtains FDA approval to expand ProMRI clinical trial
22 November 2013 German manufacturer of cardiac devices Biotronik has obtained US Food and Drug Administration (FDA) approval to expand its ongoing ProMRI...

J&J's Ethicon signs collaboration agreement with Megadyne on electrosurgery products
22 November 2013 Ethicon Endo-Surgery (Ethicon), a subsidiary of Johnson & Johnson, has entered into a collaboration agreement with US-based Megadyne Medical to provide a comprehensive portfolio of solutions...

Medtronic reports encouraging results from early feasibility study of Valiant Mona LSA stent graft system
21 November 2013 US-based Medtronic has reported that its Valiant 'Mona LSA' branch thoracic stent graft system demonstrated proof-of-concept in a first-in-human study being conducted under the US Food and...

Boston Scientific obtains FDA and CE Mark approvals for new microcatheter
21 November 2013 Boston Scientific has obtained US Food and Drug Administration (FDA) clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to embolise peripheral blood vessels in...

Gore Launches early cannulation capable vascular graft for haemodialysis patients
20 November 2013 W L Gore & Associates (Gore) has launched its Gore Acuseal vascular graft, a low-bleed, tri-layer vascular graft that includes an elastomeric middle membrane between inner and outer layers...

Boston Scientific’s Vercise DBS system gets CE Mark for treatment of dystonia
20 November 2013 Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system, which is designed for treatment of intractable primary and secondary dystonia, a...

CareFusion to acquire GE Healthcare’s Vital Signs unit for $500m
19 November 2013 CareFusion has signed a definitive agreement to acquire the vital signs division of GE Healthcare for $500m as part of its strategic plans to expand its respiratory care and...

Oraya Therapeutics reveals initial three-year results from INTREPID study
19 November 2013 Oraya Therapeutics has announced the initial three-year safety follow-up data from its INTREPID study of Oraya Therapy stereotactic radiotherapy for the treatment of wet age-related...

Boston Scientific’s Lotus Valve System commercially launched in Germany
18 November 2013 Boston Scientific has announced the first commercial implants of its Lotus valve system, which has recently received the CE mark approval, in the German...

Lumenis' next generation retina laser treatment device receives US and Japanese clearances
18 November 2013 Lumenis, a manufacturer of medical and cosmetic laser and light-based systems, has obtained the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare...

NeuroPace obtains FDA premarket approval for implantable neurostimulator to treat epilepsy
15 November 2013 NeuroPace has obtained US Food and Drug Administration (FDA) premarket approval for its NeuroPace RNS system, an implantable therapeutic device that utilises responsive neurostimulation to...

Hologic’s Aptima HPV assay obtains Health Canada approval for use on Panther system
15 November 2013 Diagnostic and medical imaging systems provider Hologic has obtained Health Canada approval for use of its Aptima HPV assay on the company's completely automated Panther...

AngioScore unveils preliminary clinical trial results of new drug-coated scoring balloon catheter
14 November 2013 US-based AngioScore has announced detailed preliminary clinical trial results from the first-in-human (FIH) study (PATENT-C) of the drug-coated AngioSculpt scoring balloon...

Synapse Biomedical’s diaphragm pacing system wins Canadian approval for SCI breathing applications
14 November 2013 US-based Synapse Biomedical has received approval from the Health Canada for its NeuRx diaphragm pacing system (DPS), designed to assist ventilator-dependent spinal cord injury (SCI) patients...

Myriad Genetics launches new melanoma diagnostic test
13 November 2013 US-based molecular diagnostic firm Myriad Genetics has launched its Myriad myPath Melanoma, a new diagnostic test designed specifically for difficult to diagnose melanoma...

Draeger unveils new non-invasive jaundice meter for infants in UK
13 November 2013 Germany-based Draeger is to launch its JM-105 jaundice meter in the UK; it is a new device for non-invasive transcutaneous bilirubinometer designed to identify at-risk infants as young as the...

Grifols to buy Novartis’s diagnostics business for $1.7bn
12 November 2013 Spanish company Grifols has announced a definitive agreement to acquire Novartis’s blood transfusion diagnostics unit for...

Ethicon Energy announces launch of articulating laparoscopic energy device in US
12 November 2013 Ethicon Endo-Surgery (Ethicon), part of the Johnson & Johnson group of companies, has announced that its first-to-market Enseal G2 articulating tissue sealer is now available in the...

Sorin reports first implant of Mitroflow Valsalva Conduit in Europe
11 November 2013 Sorin Group has announced the first European implant of Mitroflow Valsalva Conduit at Sant'Orsola-Malpighi Hospital, Bologna,...

Fujifilm SonoSite obtains FDA 510(k) clearance for X-Porte ultrasound kiosk
11 November 2013 US-based developer of ultrasound tools Fujifilm SonoSite has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its X-Porte ultrasound...

Medtronic’s lead alert system gets FDA approval for use with non-Medtronic devices
08 November 2013 Medtronic has secured the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software, designed for use with Durata and Riata (St Jude Medical) and Endotak...

Hologic’s Aptima HPV 16 18/45 genotype assay obtains FDA approval
08 November 2013 Diagnostic and medical imaging systems provider Hologic has obtained the US Food and Drug Administration (FDA) approval for its Aptima HPV 16 18/45 genotype assay, which can be used on a...

Medtronic gets FDA approval to begin US renal denervation clinical trial
07 November 2013 Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate SYMPLICITY HTN-4, the first randomised trial to investigate...

Gore secures FDA clearance for 25cm Viabahn stent graft
07 November 2013 W L Gore & Associates (Gore) has obtained US Food and Drug Administration (FDA) approval for its 25cm Viabahn endoprosthesis, which is treated with a heparin bio-active coating, for...

Ventana’s PALMS study shows favourable results of Roche's CINtec PLUS cytology test
06 November 2013 Ventana Medical Systems (Ventana), a member of the Roche Group, has announced the positive findings of the Primary ASC-US LSIL Marker Study (PALMS) that have been published in the Journal of...

Biotronik secures CE Mark approval for covered coronary stent system
06 November 2013 German firm Biotronik has obtained CE mark approval for its PK Papyrus covered coronary stent system, designed for the treatment of acute coronary artery...

Samsung releases its first digital radiography system in US
05 November 2013 Samsung Electronics America has announced the US release of its first Digital Radiology (DR) system, the Samsung XGEO GC80, designed to deliver high-image quality, fast results and...

AMIC files 510(k) pre-market notification for FDA approval of brachytherapy cancer product
05 November 2013 Advanced Medical Isotope (AMIC) has filed pre-market notification to the US Food and Drug Administration (FDA) pursuant to Section 510(k) of the US Food, Drug and Cosmetic Act for its...

Boston Scientific closes $275m acquisition of CR Bard's electrophysiology business
04 November 2013 US-based Boston Scientific has finalised its $275m acquisition of CR Bard's electrophysiology business, aimed at enhancing its capabilities in the growing market for advanced...

Novo Nordisk obtains FDA clearance for insulin dose system
04 November 2013 Novo Nordisk has obtained US Food and Drug Administration (FDA) clearance for its prefilled insulin pens NovoRapid FlexTouch and Levemir...

Svelte Medical Systems secures additional $22m in private financing
01 November 2013 US-based Svelte Medical Systems has raised $22m of new capital to complete DIRECT II study, a pivotal clinical study, and prepare for the European commercialisation of its two drug-eluting...

RAUMEDIC obtains FDA 510(k) clearance for Neurovent-PTO multimodal catheter
01 November 2013 German firm RAUMEDIC has obtained the 510(k) clearance from the US Food and Drug Administration (FDA) to market Neurovent-PTO, a multimodal catheter designed to measure intracranial pressure...

October 2013

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Apollo Endosurgery acquires Allergan’s obesity intervention division for up to $110m
31 October 2013 Developer of medical devices and endoscopic surgical procedures Apollo Endosurgery has entered into a definitive agreement to acquire the obesity intervention division of Allergan for up to...

NLT Spine obtains FDA 510(k) clearance for next-generation spinal fusion devices
31 October 2013 NLT SPINE, a developer of minimally invasive spine procedures, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Prow Fusion and eSPIN, designed for spinal...

Medtronic unveils positive results from US pivotal trial of next-generation cardiac valve system
30 October 2013 Medtronic has reported that its CoreValve System met the primary endpoint in a US pivotal trial in patients who were considered too ill or frail to undergo aortic valves replacement...

St Jude Medical releases positive clinical data from Portico heart valve study
30 October 2013 St Jude Medical has released positive clinical results for the 23mm and 25mm Portico transcatheter aortic heart valves in the Portico Transfemoral CE Mark study (Portico TF CE...

PneumRx completes patient enrolment in record time for REVOLENS study
29 October 2013 US company PneumRx has completed patient enrolment in the REVOLENS study, a cost-effectiveness research programme of the PneumRx RePneu lung volume reduction coil (RePneu LVRC) in...

Boston Scientific obtains CE Mark for transcatheter aortic valve replacement device
29 October 2013 US-based Boston Scientific has obtained CE Mark for the Lotus valve system, designed to offer a unique and effective new treatment alternative for patients with severe aortic stenosis at...

Abbott obtains FDA approval for first-in-class MitraClip device
28 October 2013 Abbott has obtained US Food and Drug Administration (FDA) approval for its first-in-class, catheter-based MitraClip therapy, designed for patients with significant mitral regurgitation (MR)...

FDA approves GE Healthcare’s brain imaging drug for detection of beta amyloid
28 October 2013 GE Healthcare has announced the US Food and Drug Administration (FDA) approval for Vizamyl (Flutemetamol F18 injection), a radioactive diagnostic drug, for use with positron emission...

Valtech Cardio reports preliminary results from percutaneous annuloplasty device trial
25 October 2013 Israel-based Valtech Cardio has announced 11 patients with severe mitral regurgitation (MR) have been treated using its transfemoral Cardioband annuloplasty system in three European medical...

Boston Scientific obtains regulatory clearance for bronchial thermoplasty system in China
25 October 2013 Boston Scientific has obtained China Food and Drug Administration approval for its Alair bronchial thermoplasty system, designed to treat severe...

Hospira launches next-generation portable infusion pump system in US
24 October 2013 Hospira has announced the introduction of Sapphire infusion system, a next-generation portable pump, following regulatory clearance from the US Food and Drug Administration...

Cardiovascular Systems obtains FDA approval for first new atherectomy device
24 October 2013 US-based Cardiovascular Systems has received pre-market approval (PMA) from the US Food and Drug Administration (FDA) to market its Diamondback 360 coronary orbital atherectomy system...

CooperVision introduces Biofinity XR contact lenses
23 October 2013 Manufacturer of soft contact lenses CooperVision has launched its Biofinity XR contact lens brand, an extension to its popular Biofinity (comfilcon A) silicone hydrogel...

Medtronic begins clinical trial of next-generation cardiac valve system
23 October 2013 US-based Medtronic has launched a new clinical trial designed to evaluate the safety and effectiveness of the new CoreValve Evolut R recapturable...

AtheroMed announces encouraging results from atherectomy catheter study
22 October 2013 US-based AtheroMed has announced results from its 'Endovascular Atherectomy Safety and Effectiveness' (EASE) study, designed to evaluate the safety and effectiveness of the Phoenix...

Medtronic launches next-generation Export Advance aspiration catheter in US
22 October 2013 Medtronic has launched the Export Advance aspiration catheter, intended for thrombus removal in the peripheral vasculature in the...

Novo Nordisk's new prefilled insulin pen receives Health Canada approval
21 October 2013 Novo Nordisk Canada has obtained Health Canada approval for its Levemir FlexTouch, a disposable prefilled insulin pen containing Levemir (insulin detemir), designed for treating patients with...

Surefire Medical introduces infusion system for small vessel interventional procedures
21 October 2013 US-based developer of cancer-drug delivery catheters Surefire Medical has launched its Surefire Infusion System mT, designed to treat vessels as small as 2mm-3.5mm in...

Wright Medical to acquire French orthopaedic products maker Biotech International
18 October 2013 US-based Wright Medical Group has entered into a definitive agreement to acquire Biotech International, a French implant manufacturer, in an $80m...

Cardiosonic completes patient enrolment in TIVUS I renal denervation trial
18 October 2013 Israel-based Cardiosonic has completed the patient enrolment in the first-in-man (FIM) TIVUS I clinical study of its high-intensity, therapeutic ultrasound catheter system, developed for...

Lumenis to launch new FiberLase GYN handpiece set for gynaecological surgery
17 October 2013 Lumenis, a developer of medical laser equipment for the surgical and ophthalmology markets, has announced plans to introduce a new FiberLase GYN handpiece set as part of its product expansion...

PLC Systems secures Japanese approval for RenalGuard trial
17 October 2013 PLC Systems has obtained approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to begin a clinical trial in Japan, assessing the ability of RenalGuard therapy to reduce...

St Jude Medical obtains CE Mark approval for leadless pacemaker
16 October 2013 US-based medical technology developer St Jude Medical has acquired Nanostim and its miniature leadless pacemaker following European approval of the...

Samsung launches first tablet-based ultrasound device
16 October 2013 Samsung Electronics America has launched UGEO PT60A, its first tablet-based ultrasound system for the point-of-care (POC) market, enabling doctors to perform medical diagnoses at or near the...

Amedica launches next-generation anterior lumbar interbody spinal fusion device
16 October 2013 Amedica has launched its new Valeo II anterior lumbar (AL) interbody fusion device, designed for use with autograft to facilitate intervertebral body fusion of the spine in skeletally mature...

Covidien introduces new Capnostream 20p bedside monitor
15 October 2013 Medical devices manufacturer Covidien has announced the launch of the Capnostream 20p bedside monitor, which offers enhanced features for increasing patient safety in...

CardioKinetix announces successful completion of first Parachute procedure in China
15 October 2013 CardioKinetix, a developer of catheter-based treatment methods for heart failure, has announced the first successful completion of heart failure surgery with a new catheter-based...

Neuros Medical receives FDA approval for pivotal clinical study of Altius system
14 October 2013 Neuros Medical has obtained an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a pivotal clinical trial, designed to evaluate the safety...

FDA approves Crospon’s EsoFLIP balloon dilation catheter
14 October 2013 Ireland-based manufacturer Crospon has announced that the US Food and Drug Administration has approved its EsoFLIP balloon dilation...

EU Parliament votes against medical regulation for electronic cigarettes
11 October 2013 Members of the European Parliament (MEPs) have voted this week on the Tobacco Products Directive (TPD), with the majority rejecting the Commission's proposal to regulate electronic cigarettes...

Boston Scientific initiates clinical trial of Innova peripheral vascular drug-eluting stent system
11 October 2013 Boston Scientific has initiated the MAJESTIC trial designed to evaluate the safety and effectiveness of Innova peripheral vascular self-expanding DES system in treating superficial femoral...

Medtronic and Apollo join forces to provide low-cost dialysis system to patients in India
10 October 2013 Medtronic and Indian healthcare chain Apollo Hospitals Enterprise have joined forces to provide a cost-effective, efficient and portable hemodialysis system to end-stage renal disease...

US FDA says Medtronic CRT Devices are beneficial for patients with heart conditions
10 October 2013 Medtronic has announced that the US Food and Drug Administration (FDA) advisory panel has voted in favour of expanding indication for all Medtronic's cleared cardiac resynchronisation...

Quest Diagnostics buys Converge Diagnostic Services
09 October 2013 Quest Diagnostics has acquired ConVerge Diagnostic Services from Water Street Healthcare Partners, boosting Quest's growth strategy in New England,...

ProTip and Strasbourg University Hospitals successfully implant artificial larynx in first patient
09 October 2013 France-based ProTip SAS has reported its artificial larynx, ENTegral, has been successfully implanted in a human patient at Strasbourg University...

MDxHealth’s prostate cancer test meets endpoints in DOCUMENT trial
08 October 2013 Molecular diagnostic company MDxHealth has reported that its ConfirmMDx for prostate cancer test met all primary endpoints in the recently completed multicentre, blinded 'Detection of Cancer...

Binder Biomedical gets FDA approval for anterior lumbar fixation system
08 October 2013 Binder Biomedical has received US Food and Drug Administration (FDA) approval for its Logic, an anterior lumbar fixation system with a simple, one-step locking...

Medtronic launches new cervical cage system in Europe
07 October 2013 Medtronic has obtained the CE Mark and initiated the European launch of its Compact Cornerstone-SR Alliance cage, a new cervical system designed to treat cervical disc...

Bausch + Lomb Technolas obtains CE mark for next generation excimer laser workstation
07 October 2013 Bausch + Lomb, a US-based developer of eye health products, including contact lenses, lens care products, medicines and implants for eye diseases, has received the CE mark for its Technolas...

Nanobiosym’s Gene-RADAR sensing technology wins grand prize in Nokia Sensing XCHALLENGE
04 October 2013 Nanobiosym Health RADAR, a US-based research incubator institute, has been awarded the $525,000 grand prize for its Gene-RADAR sensing technology in the first $2.25m Nokia Sensing...

Precision Spine secures expanded FDA 510(k) clearance for Reform pedicle screw system
04 October 2013 Precision Spine, a US-based spinal device company, has secured the US Food and Drug Administration 510(k) clearance for the additional components of its Reform pedicle screw system for...

EndoCross's Enabler-C catheter system meets early success in first-in-human study
03 October 2013 Israel-based medical devices developer EndoCross has revealed that its Enabler-C catheter system has demonstrated 'significant capability' for crossing coronary chronic total occlusions (CTO)...

Ventana launches fully automated BRAF V600E immunohistochemistry test
03 October 2013 Ventana Medical Systems (Ventana), a member of the Roche Group, has announced the global launch of its BRAF V600E immunohistochemistry (IHC) test, which is designed to detect the BRAF...

Biotronik launches new Ilesto implantable cardiac defibrillator
02 October 2013 Biotronik, a German medical device company, has launched its next-generation technology platform, Ilesto DX, following FDA approval for its Ilesto family of...

Cerus submits first of three modules for Intercept platelet premarket approval application
02 October 2013 US-based biomedical products company Cerus has submitted the first of three modules for its premarket approval (PMA) application to the US Food and Drug Administration (FDA) for review of...

KCI, LifeCell and Systagenix agree to merge operations
01 October 2013 US-based Kinetic Concepts (KCI), LifeCell and Systagenix have joined forces to form a single entity that focuses on wound care, biologics and regenerative...

ImThera Medical completes enrolment in study of sleep therapy system
01 October 2013 US-based ImThera Medical has completed the patient enrolment in THN2 study, an international, prospective multi-centre study designed to evaluate the safety and efficacy of its aura6000 system...

September 2013

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Medtronic obtains FDA clearance for artificial pancreas system
30 September 2013 Medtronic has obtained US Food and Drug Administration (FDA) approval for its first generation artificial pancreas system, the MiniMed 530G with Enlite, with Threshold Suspend automation...

NxThera reports first patients treated in Rezum II IDE BPH clinical trial
30 September 2013 US-based NxThera has announced the successful treatment of first patients in NxThera's Rezūm II US clinical trial designed for the treatment of benign prostatic hyperplasia...

Olympus launches new surgical tool for sinus and endoscopic skull base surgeries
27 September 2013 US-based medical and surgical products designer Olympus has launched Diego Elite Multidebrider, a new tool designed to deliver optimal tissue dissection with built-in hemostasis and help...

NuVasive introduces Precept spinal system in Japan
27 September 2013 Design, development and marketer of products for surgical treatment of spine disorders company NuVasive has introduced its Precept system in Japan, treating the first patients with...

Stryker to acquire Mako Surgical for $1.65bn
26 September 2013 US medical equipment manufacturer Stryker has signed a definitive agreement to acquire Mako Surgical, developer of robotic solution and implants for minimally invasive orthopaedic procedures,...

Oraya Therapeutics reports positive two-year results from INTREPID study
26 September 2013 Oraya Therapeutics has reported positive two-year results from its INTREPID study, designed to evaluate the safety and efficacy of the IRay stereotactic radiotherapy system for the treatment of...

Luminex secures FDA and European approval for personalised medicine genotyping assay
25 September 2013 a US-based biotechnology company Luminex has received the US Food and Drug Adminstration and European approval for a comprehensive genotyping assay, xTAG CYP2C19 kit, an in vitro diagnostic...

Medtronic secures FDA approval for self-expanding stent for use in lower extremities
25 September 2013 Medtronic has obtained the US Food and Drug Administration (FDA) approval to market its Complete SE (self-expanding) vascular stent, designed for use in lower extremities, including...

Given Imaging secures Japanese clearance for next-generation PillCam SB system
24 September 2013 Israel-based medical devices developer Given Imaging has received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its third-generation video capsule PillCam SB3...

FDA releases final guidance governing mobile medical apps
24 September 2013 The US Food and Drug Administration (FDA) has issued final guidance concerning the regulation of mobile medical applications that have the potential to harm consumers if they do not...

Sapheon submits first 'PMA' module for VenaSeal closure system
23 September 2013 US-based Sapheon has submitted its first pre-market approval (PMA) module to the US Food and Drug Administration (FDA) for VenaSeal sapheon closure system, which is designed for the treatment...

Ocular Therapeutix secures favourable votes from FDA panel for post-surgical sealant
23 September 2013 US-based Ocular Therapeutix has secured favourable votes from the ophthalmic devices panel of the Food and Drug Administration (FDA) for its ReSure sealant, a hydrogel designed for...

Ventana and Boehringer Ingelheim to develop companion diagnostic tests for oncology programmes
20 September 2013 Ventana Medical Systems (Ventana), a member of the Roche Group, has signed a collaboration agreement with a German pharmaceutical group Boehringer Ingelheim to develop companion diagnostic...

Crosstrees Medical secures FDA 510(k) approval for its PVA pod system
20 September 2013 US-based Crosstrees Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Crosstrees PVA Pod System, designed to control bone cement delivery and decrease...

AngioDynamics secures Health Canada approval for tip location system
19 September 2013 US-based AngioDynamics has announced that its distribution partner, Medcomp, has received Health Canada approval for the Celerity tip location system, designed to be used as an alternative to...

OligoMedic to launch injectable cartilage void-filler in Europe
19 September 2013 Canadian manufacturer of osteoarthritis products OligoMedic has announced the launch of its CE mark injectable implant JointRep, which is a cartilage repair product developed for treatment...

Abbott secures CE Mark for blood glucose and ketone monitoring system
18 September 2013 US-based Abbott has received CE Marking in Europe for the FreeStyle Optium Neo blood glucose and ketone monitoring system, designed to track glucose trends and log insulin, which may help...

Boston Scientific reports positive six-month results from Lotus valve system study
18 September 2013 US-based medical device manufacturer Boston Scientific has reported positive six-month results from the first 60 patients enroled in the REPRISE II clinical trial, designed to evaluate the...

Regentis Biomaterials’ knee cartilage repair technology shows impressive recovery rates
17 September 2013 Regentis Biomaterials, a tissue repair company, has announced new clinical data demonstrating the efficacy and safety of its GelrinC implant, designed for the treatment of articular cartilage...

Vital Access obtains FDA clearance for vascular needle guide
17 September 2013 US-based Vital Access has obtained the US Food and Drug Administration (FDA) market clearance for its patented VWING vascular needle guide to provide vascular access for haemodialysis...

NeoTract obtains FDA de novo clearance for prostate implant
16 September 2013 US-based NeoTract has received the US Food and Drug Administration (FDA) authorisation to market UroLift system, which is the first permanent implant designed to relieve low or blocked urine...

Medigus’s endoscopic system secures marketing approval in Israel
16 September 2013 Medigus has obtained approval from the Israeli Ministry of Health (MEA) for the SRS endoscopic system, designed for the treatment of gastroesophageal reflux disease...

Boston Scientific completes patient enrolment in coronary stent system trial study
13 September 2013 Boston Scientific has completed enrolment in the EVOLVE II randomised, controlled clinical trial, designed to further assess the safety and effectiveness of the company's Synergy stent...

Sunshine Heart implants first US patient in pivotal study of C-Pulse system
13 September 2013 Sunshine Heart has successfully implanted first patient with C-Pulse system in the COUNTER HF, a prospective, randomised, multi-centre, controlled trial designed to evaluate the safety and...

Gore secures FDA clearance for endovascular repair of Type B descending thoracic dissections
12 September 2013 W L Gore & Associates has received the US Food and Drug Administration (FDA) approval for its Conformable Gore TAG, to be used for endovascular repair of acute and chronic Type B dissections of...

Direct Flow Medical enrols first patient in transcatheter aortic heart valve system trial in US
12 September 2013 Direct Flow Medical, developer of transcatheter heart valve technologies, has enrolled the first patient in the SALUS feasibility trial to evaluate its transcatheter aortic heart valve system...

NanoString secures FDA clearance for new breast cancer prognostic gene signature assay
11 September 2013 NanoString Technologies, a US-based molecular diagnostic products provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Prosigna breast cancer...

Precision Spine launches new anterior cervical plate system in US
11 September 2013 Precision Spine, a US-based spinal device company, has launched its Slimplicity solo anterior cervical plate system, which recently received 510(k) clearance from the US Food and Drug...

Cook Medical launches new device to simplify percutaneous nephrolithotomy procedures
10 September 2013 Global developer of minimally invasive medical devices Cook Medical has introduced LithAssist, a new device that allows physicians to control suction more easily during percutaneous...

Moirai Orthopaedics secures CE Mark approval for PIR knee system
10 September 2013 Moirai Orthopaedics, a US-based orthopaedic implant development company, has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) system, which is designed to treat...

Parascript obtains USFDA approval for AccuDetect computer-aided detection system
09 September 2013 Parascript has received US Food and Drug Administration approval for its AccuDetect 6.1 computer-aided detection (CAD) system, which helps radiologists improve finding breast...

Enzymatics acquires ArcherDx for up to $50m
09 September 2013 Enzymatics has acquired ArcherDx, developer of next-generation sequencing-based kits and software solutions for use in investigating cancer treatment, for up to $50m in cash, equity, and...

Myriad Genetics launches new multi-gene diagnostic cancer panel
06 September 2013 Myriad Genetics, a molecular diagnostic company, has launched myRisk Hereditary Cancer test, a new multi-gene diagnostic cancer panel designed to provide increased sensitivity by analysing 25...

Brainsway reports positive Deep TMS system trial data for OCD
06 September 2013 Brainsway has announced positive final results from its double-blind, placebo-controlled study of its deep transcranial magnetic stimulation (Deep TMS) system for treating...

Abbott reports positive preliminary results for highly sensitive troponin test
05 September 2013 Abbott has reported positive preliminary results from a study evaluating its Architect Stat High Sensitive Troponin-I (hsTnI) assay at the European Society of Cardiology (ESC) Congress...

Abyrx secures USFDA 510(k) clearance for new resorbable hemostatic bone putty
05 September 2013 Abyrx, a therapeutic device company, has obtained US Food and Drug Administration clearance for its Hemasorb Plus, a new resorbable hemostatic bone putty designed for clinical use in the...

CE Mark gained by Coherex Medical for left atrial appendage occlusion system
04 September 2013 Coherex Medical, a US-based medical device maker, has received CE Mark approval for its WaveCrest left atrial appendage (LAA) occlusion...

Tensys Medical secures CE Mark for two hemodynamic patient monitoring systems
04 September 2013 US-based Tensys Medical has received CE Mark approval for both the TL-400 and TL-300 next-generation continuous, non-invasive hemodynamic patient monitoring...

Philips launches new ultrasound system for complicated imaging needs
03 September 2013 Royal Philips Electronics has launched the new Epiq premium ultrasound system with new nSIGHT technology and Anatomical Intelligence, designed to visualise deeper levels of anatomical detail...

Medtronic reports positive preliminary results from Global SYMPLICITY Registry
03 September 2013 Medtronic has reported preliminary data from the Global SYMPLICITY Registry, a multi-centre, prospective, observational registry designed to collect comprehensive data evaluating procedural...

Biotronik’s Home Monitoring reduces all-cause mortality in ICD and CRT-D patients
02 September 2013 Biotronik, a German manufacturer of cardiac devices, reported positive results from the IN-TIME study, a randomised, controlled trial designed to assess the influence of home monitoring on...

CardioKinetix announces introduction of minimally invasive structural heart device in Asia
02 September 2013 CardioKinetix, a developer of catheter-based treatment methods for heart failure, has announced the first successful completion of heart failure surgery with Parachute ventricular...

August 2013

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St Jude Medical obtains CE Mark approval for new renal denervation system
30 August 2013 US-based medical technology developer St Jude Medical has obtained CE Mark approval for its next-generation EnligHTN renal denervation system, designed for treating patients with...

Advanced Bionics wins FDA approval for new behind-the-ear sound processor
30 August 2013 Advanced Bionics, a subsidiary of Switzerland-based Sonova Group, has received US Food and Drug Administration approval for commercialisation of its new Naída CI Q70 (Naída CI) sound...

LDR secures first FDA clearance for two-level cervical disc replacement
29 August 2013 LDR has obtained approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C) for two-level indications in the...

Spinal Modulation enrols first patient in neurostimulator system study
29 August 2013 Spinal Modulation has enrolled the first patient in US pivotal study of the investigational Axium neurostimulator system for chronic...

Lombard treats first US patients with Aorfix stent graft
28 August 2013 UK-based Lombard Medical Technologies (LMT) has successfully treated the first US patients with Aorfix, a flexible stent graft used for endovascular repair of abdominal aortic aneurysms...

HeartWare to start enrolment for ENDURANCE blood-pressure monitoring trial
28 August 2013 Medical device company HeartWare International has obtained the US Food and Drug Administration (FDA) approval to enrol an additional patient cohort in the pivotal destination therapy...

Allied Healthcare obtains CE marking for cardiovascular product
27 August 2013 Allied Healthcare Group has obtained Conformité Européenne (CE) marking for its lead regenerative product CardioCel, used for congenital heart disease treatment and cardiovascular...

FDA grants 510(k) clearance for Zimmer PSI Shoulder system
27 August 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Zimmer Patient Specific Instruments (PSI) shoulder...

Infraredx secures investment from Japanese firm Nipro
23 August 2013 Infraredx, a US-based medical device firm focused on coronary artery disease, has secured a $25m equity investment from Nipro, a Japanese medical device and pharmaceutical...

InSightec obtains Canadian nod for non-invasive MR guided focused ultrasound therapy
23 August 2013 InSightec, an Israel- based provider of MR guided focused ultrasound therapy, has obtained the approval from Health Canada for its ExAblate system designed to treat both uterine fibroids and...

Abbott closes acquisition of Idev Technologies for $310m
22 August 2013 US-based Abbott has completed the acquisition of Idev Technologies, a Texas-based company focused on developing next-generation medical devices, for $310m in a mixed net cash and debt...

Tensys obtains Chinese approval for non-invasive hemodynamic patient monitor
22 August 2013 US-based Tensys Medical has received Chinese State Food & Drug Administration (SFDA) approval for its next-generation continuous, non-invasive hemodynamic patient monitoring...

Boston Scientific completes patient enrollment in SuperNOVA trial
21 August 2013 Boston Scientific has completed patient enrollment in the SuperNOVA trial designed to evaluate the long-term (12 month) safety and effectiveness of the Innova self-expanding stent system...

C R Bard to acquire Medafor for $200m
21 August 2013 C R Bard has agreed to acquire Medafor, a developer and supplier of plant-based hemostatic agents, for a purchase price of...

Staar Surgical’s Visian ICL with CentraFLOW technology wins Indian regulatory approval
20 August 2013 Staar Surgical, a US-based ophthalmic products manufacturer, has obtained regulatory clearance from India's Central Drugs Standard Control Organisation (CDSCO) to market its Visian...

St Jude Medical to buy Swiss medical device maker Endosense for $331m
20 August 2013 US-based medical device maker St Jude Medical has agreed to acquire Endosense, a Switzerland-based medical technology company that works in the development of catheter ablation for...

Cardica submits 510(k) application for cutting and stapling device
19 August 2013 US-based Cardica has sought 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroCutter XCHANGE 30, a cutting and stapling device designed for minimally invasive...

Northwestern Memorial Healthcare enrolls first patient for Abbott’s ABSORB III clinical trial
19 August 2013 The Bluhm Cardiovascular Institute of Northwestern Memorial HealthCare in Chicago, US, has enrolled the first patient in ABSORB III, a clinical trial to understand the safety and effectiveness...

Ortho Kinematics obtains FDA 510k clearance for vertebral motion analysis system
16 August 2013 Ortho Kinematics, a US based diagnostic technology company, has received a 510K clearance from the US regulatory agency to expand the vertebral motion analysis (VMA) diagnostic technology to...

St Jude Medical obtains US FDA approval for ablation catheters
16 August 2013 US-based medical device maker St Jude Medical has secured approval from the US Food and Drug Administration for its MediGuide enabled ablation catheters, designed to treat irregular...

Quantel Medical’s glaucoma laser gets US FDA clearance for clinical use
15 August 2013 France-based ophthalmic ultrasound and laser devices company Quantel Medical has obtained US Food and Drug Administration (FDA) approval for the clinical use of its selective laser...

Natus Neurology's EMG system secures approvals in US and Canada
15 August 2013 Natus Neurology has secured regulatory clearances in the US and Canada for its new nerve conduction device, the UltraPro S100 EMG...

Century Medical seeks Japanese approval for Cardica’s cartridge-based microcutter device
14 August 2013 Medical device distributor Century Medical has sought approval for Cardica's cartridge-based microcutter device, called MicroCutter XCHANGE 30, from the Japanese regulatory...

Baxter secures China’s conditional approval for $4bn Gambro acquisition deal
14 August 2013 Baxter International has secured conditional approval from the Chinese Ministry of Commerce for its proposed $4bn acquisition deal of Swedish dialysis equipment manufacturer Gambro...

EPGL Medical develops smart treatment devices for physicians
13 August 2013 US medical device manufacturer EPGL Medical has developed smart treatment devices that enhance situational awareness during operations, reducing risk to...

Given Imaging’s PillCam SB 3 video capsule receives 510(k) clearance
13 August 2013 Israel-based medical devices developer Given Imaging has got clearance from the US regulatory agency to market its next-generation video capsule PillCam SB 3, which can detect small...

Medtronic buys patient monitoring firm Cardiocom
12 August 2013 Medtronic, a US-based medical device manufacturer, has purchased Cardiocom, a patient-monitoring device maker, in a $200m all-cash deal....

RTI Surgical launches Tritium Sternal Cable Plating for open heart procedures
12 August 2013 RTI Surgical, a US-based global surgical implant firm, has launched Tritium Sternal Cable Plating (SCP), a system designed for the closure of median sternotomies following open-heart...

US scientists develop ultrasound device for healing chronic wounds
09 August 2013 Researchers at the Drexel University School of Biomedical Engineering, Science and Health Systems have developed a small therapeutic ultrasound device that could speed-up the process of...

US FDA approves diagnostic test to detect HIV-1 antigen, HIV-1/2 antibodies
09 August 2013 Orgenics, a subsidiary of Alere, has received the US Food and Drug Administration (FDA) approval for its rapid diagnostic test that can simultaneously detect HIV-1 p24 antigen and antibodies...

CorMatrix Cardiovascular secures patents for biomaterial replacement heart valve in US
08 August 2013 CorMatrix Cardiovascular has received three patents in the US for its replacement heart valves that use a biomaterial called extracellular matrix...

Cyberdyne wins German certification for robotic suit to rehabilitate lower body
08 August 2013 Cyberdyne, a Japanese robotics and technology company, has received an EC certificate from German safety monitoring agency TÜV Rheinland for its robot suit, called Hybrid Assistive Limb...

Medtronic introduces MRI implantable neurostimulation systems for chronic pain treatment
07 August 2013 US-based medical technology provider Medtronic has introduced an implantable neurostimulation system for treatment of chronic pain and reduces or eliminates the risks associated with the...

Valeant Pharmaceuticals finalises acquisition of Bausch + Lomb
07 August 2013 Valeant Pharmaceuticals, a Canada-based pharmaceutical firm, has completed the purchase of Bausch + Lomb Holdings, a US-based manufacturer of eye health...

Quidel receives 510(k) clearance from US FDA for Sofia hCG FIA
06 August 2013 Diagnostic healthcare solutions manufacturer Quidel has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia human chorionic gonadotrophin (hCG)...

IMRIS receives CE mark for ceiling-mounted intraoperative computed tomography
06 August 2013 IMRIS, an image-guided therapy solutions provider, has received CE mark for its ceiling-mounted VISIUS intraoperative computed tomography...

Cerevast Therapeutics initiates patient enrolment for ultrasonic headframe clinical trial
05 August 2013 Cerevast Therapeutics, a US-based medical technology firm, has begun enrolling patients for the Phase III clinical trial to evaluate the use of Clotbust ER ultrasonic headframe, which is meant...

Sealantis obtains CE mark for Seal-V bioresorbable sealant
05 August 2013 Sealantis, an Israel-based developer of protein-free alga-mimetic tissue adhesives, has obtained CE mark for its protein-free bioresorbable sealant...

Convergent Dental receives FDA approval for CO2 laser technology system
02 August 2013 Dental equipment and technology provider Convergent Dental has received approval from the US Food and Drug Administration (FDA) for its CO2 laser technology system called Solea, which is used...

Hologic's SE Femur Exam receives FDA approval on DXA platform to assess AFF
02 August 2013 Medical imaging systems and surgical products developer Hologic has received approval from the US Food and Drug Administration (FDA) for its Single Energy (SE) Femur Exam on its dual energy...

Ambio Health receives FDA cleared for at-home remote health monitoring system
01 August 2013 Ambio Health, a provider of health monitoring systems, has received 510(k) clearance from the US Food and Drug Administration for its Ambio Remote Health Monitoring System, a wireless remote...

Kinetic Concepts to acquire wound care products maker Systagenix
01 August 2013 Kinetic Concepts (KCI), a US-based medical technology provider, has signed a definitive agreement to acquire Systagenix, a UK-based advanced wound care (AWC) products maker, for $485m as part...

July 2013

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Toshiba Medical Systems UK works towards achieving zero waste to landfill
31 July 2013 Toshiba Medical Systems UK (TMS-UK), a unit of Japan-based Toshiba, has minimised its impact on environment through fuel, energy and waste reduction as part of its efforts to achieve 'zero waste...

Teleflex subsidiary receives 510(k) clearance for balloon dilatation catheters
31 July 2013 US-based Teleflex’s subsidiary Hotspur Technologies has received US regulatory clearance to market its ARROW GPSCath balloon dilatation catheters in higher rated burst pressure (RBP) and 80cm...

Stereotaxis wins US clearance to market Vdrive with V-Sono System
30 July 2013 US-based Stereotaxis has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography (ICE)...

InSightec receives Chinese clearance for ExAblate system to treat uterine fibroids
30 July 2013 Israel-based ultrasound technology provider InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its non-invasive ExAblate system, which is used in the...

PPG Industries to sell stake in photochromic lens unit for $1.73bn
29 July 2013 US-based specialised chemicals firm PPG Industries has agreed to sell its 51% stake in Transitions Optical to France-based Essilor International for...

RaySearch receives Chinese clearance for RayStation treatment planning system
29 July 2013 Sweden-based medical technology provider RaySearch Laboratories has received approval from China Food and Drug Administration (CFDA) to market its treatment planning system, ...

Abbott secures US FDA approval for blood glucose monitoring system
26 July 2013 US-based Abbott has secured approval from the US Food and Drug Administration for its FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring System, a device that will help hospitals...

BD secures approval for integrated IV catheter system for subcutaneous therapy
26 July 2013 Global medical device maker Becton, Dickinson and Company (BD) has received approval from the European regulatory authorities for its BD Saf-T-Intima Safety Integrated IV Catheter System, which...

Hologic’s Aptima HPV assay on Panther system approved for cervical cancer screening
25 July 2013 Hologic has received US Food and Drug Administration (FDA) approval for its Aptima HPV assay, which can be used on completely automated Panther...

Boston Scientific wins 510(k) approval for mapping system to diagnose arrhythmia
25 July 2013 Boston Scientific has secured 510(k) approval from US Food and Drug Administration (FDA) to market Rhythmia Mapping System, a 3D mapping and navigation solution that can be used in cardiac...

Physio-Control’s latest chest compression system provides better CPR
24 July 2013 Physio-Control has developed Lucas 2, a system that delivers continuous chest compressions in order to maintain blood flow to the brain and other organs when a person suffers a cardiac...

Co-Diagnostics and DNA Logix establish JV to sell diagnostic devices in developing nations
24 July 2013 US-based Co-Diagnostics and DNA Logix have reached an agreement to set up a joint venture, Co-Diagnostics HBDC, which will sell diagnostic devices to high burden developing countries...

Techne closes acquisition of haematology products maker Bionostics
23 July 2013 Minneapolis-based Techne has closed the acquisition of Bionostics Holdings and its subsidiary Bionostics in a cash deal worth...

IMRIS secures US FDA clearance to market ceiling-mounted intraoperative CT solution
23 July 2013 IMRIS has received 510K clearance from the US Food and Drug Administration for its Visius iCT, a CT imaging solution for the spinal and neurosurgical...

Elekta’s Clarity 4D Monitoring system for prostate cancer secures CE Mark
22 July 2013 Sweden-based Elekta has secured CE Mark for its Clarity 4D Monitoring system, which will allow doctors to monitor the motion of prostate with an accuracy of even sub-millimetre during...

Spinal Restoration’s Phase III study of Biostat System yields disappointing results
22 July 2013 Texas-based minimally invasive therapies developer Spinal Restoration has said that its Phase III Investigational New Drug (IND) study conducted to test the effectiveness of Biostat System did...

Mindray Medical closes acquisition of Zonare Medical Systems
19 July 2013 China-based medical devices developer Mindray Medical International has completed the acquisition of Zonare Medical Systems, a US-based ultrasound technology provider, for $101.7m as part of...

Intuitive Surgical cuts 2013 revenue forecast over robot systems concerns
19 July 2013 Intuitive Surgical has cut its 2013 revenue forecast amid concerns about its da Vinci surgical robot systems and issuance of a warning letter by the US...

Misonix receives Chinese clearance to market bone-cutting device
18 July 2013 New York-based ultrasonic device manufacturer Misonix has received clearance from China's State Food and Drug Administration (SFDA) to sell its bone-cutting and compression device,...

UK scientists develop intelligent surgical knife to detect cancerous tissue
18 July 2013 Researchers at Imperial College London in the UK have created an intelligent knife, which can help surgeons identify cancerous tissue....

RTI Biologics closes acquisition of Pioneer Surgical Technology
17 July 2013 RTI Biologics, a Florida-based manufacturer of orthopaedic and biologic implants, has completed the acquisition of Pioneer Surgical Technology for $130m as part of its strategy to boost its...

US FDA approves marketing of brain-wave test to assess ADHD in children
17 July 2013 The US Food and Drug Administration (FDA) has approved marketing of Neuropsychiatric EEG-Based Assessment Aid (NEBA), a brain-wave test to assess attention deficit hyperactivity disorder (ADHD)...

Abbott to expand medical device business with two acquisitions
16 July 2013 Abbott is expanding its medical device business with the $710m acquisition of OptiMedica, a Silicon Valley-based ophthalmic device firm, and IDEV Technologies, a Texas-based stent manufacturer....

Given Imaging’s PillCam COLON video capsule receives regulatory clearance in Japan
16 July 2013 Given Imaging has received clearance from the Pharmaceuticals & Medical Devices Agency (PMDA) of Japan for its PillCam COLON, a video capsule to diagnose colonic disease in patients unable to...

FDA approves sale of biological method to test effectiveness of steam sterilisation
15 July 2013 Ohio-based Steris has secured approval from the US Food and Drug Administration (FDA) to market its Verify Cronos self-contained biological indicator (SCBI), a new and faster method of testing...

US researchers develop tool to analyse baby cries to identify health problems
15 July 2013 A team of researchers from Brown University and Women & Infants Hospital of Rhode Island, US, has developed a computer-based tool that analyses the cries of infants, which will help doctors...

LifeCodexx’s PrenaTest now detects chromosomal abronomalities after pregnancy week nine
12 July 2013 LifeCodexx, a Germany-based developer of molecular diagnostic tests, has announced that its improved non-invasive molecular genetic blood test, called PrenaTest, can now detect...

Medtronic introduces next-generation adjusting screws for use in spinal problem rectification
12 July 2013 Medtronic, a US-based medical device company, has introduced its fifth-generation spinal fusion system, called CD Horizon Solera Spinal System Sagittal Adjusting Screw (SAS), which could be used...

Abbott secures Japanese nod for next generation drug eluting coronary stent system
11 July 2013 Abbott, a US-based medical device firm, has received regulatory approval in Japan for its Xience Xpedition Everolimus Eluting Coronary Stent System, which can be used to treat blockages in...

Ethicon’s antimicrobial dressing gets listed in NHS Catalogue of Potential Innovations
11 July 2013 Ethicon, a surgical products developer owned by Johnson & Johnson, antimicrobial dressing Biopatch has been included in the NHS Catalogue of Potential Innovations as it has been found to...

USFDA allows TYRX to sell antibacterial envelope for use with pacemakers
10 July 2013 US-based TYRX has secured clearance from the US Food and Drug Administration (FDA) to sell its AIGISRx R, a bioresorbable and antibacterial mesh envelope that can be used with pacemakers...

Rhythmlink wins US patent for slider electrode deployment piece
10 July 2013 Rhythmlink International, a US-based medical device maker, has secured patent in the US for the design of its slider electrode, an electrode deployment...

Penumbra introduces next-generation clot extraction device
09 July 2013 Penumbra, a medical device firm, has introduced a next-generation clot extraction device called 5MAX ACE, which uses only aspiration to quickly remove blood clots that cause acute ischemic...

NeuroMetrix secures 510(k) clearance for transcutaneous electrical nerve stimulator
09 July 2013 NeuroMetrix, a medical device firm, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sensus Pain Management System, a transcutaneous electrical nerve...

CorMedix wins CE Mark for catheter lock system
08 July 2013 US-based CorMedix has gained CE Mark clearance for its Neutrolin, a catheter lock solution that has been designed to prevent catheter related bloodstream infections (CRBI) in hemodialysis...

Episurf Medical receives CE mark approval for personalised knee implant
08 July 2013 Episurf Medical, a Sweden-based medical technology provider, has secured CE mark approval for its personalised knee implant, called Episealer Femoral Condyle, which will enable the firm to sell...

Philips receives FDA clearance for AlluraClarity X-ray system
05 July 2013 Royal Philips, the Netherlands-based health company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AlluraClarity interventional X-ray system, which...

Oxford Optronix launches tissue oxygenation, blood flow monitoring systems
05 July 2013 Oxford Optronix, a UK-based instrumentation provider for clinical medicine, has introduced its third-generation tissue oxygenation and blood flow monitoring...

Retina Implant secures CE Mark for wireless subretinal microchip
04 July 2013 Retina Implant, a German developer of subretinal implants, has received the CE Mark for its wireless subretinal microchip, Alpha...

NanoString's breast cancer assay offers prognostic information
04 July 2013 NanoString Technologies, a US-based molecular diagnostic products provider, has announced that its PAM50 gene signature-based breast cancer assay offers prognostic information in...

Glide Pharma, Nypro Healthcare agree on SDI design optimisation
03 July 2013 UK-based Glide Pharma has signed an agreement with medical device manufacturer Nypro Healthcare to complete design optimisation of its needle-free delivery system Glide SDI (solid dose...

SpineGuard secures regulatory clearance for Cannulated PediGuard in Mexico
03 July 2013 SpineGuard has received regulatory approval from the Mexican healthcare regulatory authority COFEPRIS to market its Cannulated PediGuard...

Illumina applies for CE mark for MiSeqDx Cystic Fibrosis System
02 July 2013 Illumina has applied for CE Mark approval for its MiSeqDx Cystic Fibrosis System, which can identify several variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene...

Zoll Medical acquires CoAxia to expand acute critical care portfolio
02 July 2013 Zoll Medical, a Massachusetts-based manufacturer of medical devices, has acquired assets of CoAxia, a Minnesota-based medical device company that provides catheter-based perfusion...

Tangent Medical introduces NovaCath Integrated IV Catheter system
01 July 2013 Tangent Medical, a manufacturer of IV therapy products, has commercially launched its NovaCath Integrated IV Catheter System and initiated clinical evaluations of the product in several...

Boston Scientific to acquire CR Bard's electrophysiology business
01 July 2013 Boston Scientific has signed a definitive agreement to buy Bard EP, the electrophysiology (EP) unit of C.R. Bard, for $275m, as part of its strategy to improve capabilities in the growing...

June 2013

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AngioDynamics receives 510(k) approval for Xcela Plus Port family
28 June 2013 US-based invasive medical devices provider AngioDynamics has received 510(k) approval from the US Food and Drug Administration (FDA) for its Xcela Plus Port family with Pressure Activated...

Cepheid approved to market updated Xpert MRSA/SA BC test
28 June 2013 Cepheid, a US-based molecular diagnostics company, has received approval from the US Food and Drug Administration (FDA) to market its updated Xpert MRSA/SA Blood Culture (BC)...

Caldera Medical receives FDA approval for sacrocolpopexy mesh
27 June 2013 Caldera Medical, US-based developer of surgical implants has received approval from the US Food and Drug Administration (FDA) for Vertessa Lite, a polypropylene mesh for use in...

University of Washington receives funding to develop paper-based medical device
27 June 2013 The University of Washington (UW) has secured a fund of $9.6m from the US Department of Defense’s Advanced Research Projects Agency to develop a small, paper-based medical device that can...

Medtronic initiates overnight artificial pancreas system study in US
26 June 2013 Medical technology provider Medtronic has begun patient enrollments in the US Overnight Closed Loop Study, a key feasibility trial aimed at commercialising a third-generation fully...

BioFire gains FDA approval for FilmArray Blood Culture Identification Panel
26 June 2013 US-based clinical diagnostics company BioFire Diagnostics has received approval from the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID)...

BD Diagnostics, Diagenode launch Bordetella pertussis detection kit
25 June 2013 BD Diagnostics and Belgium-based biotechnology firm Diagenode have launched a new real-time Diagenode Bordetella pertussis / parapertussis real-time polymerase chain reaction (PCR) kit for use...

St Jude Medical gets CE mark clearance for Quadra Assura MP CRT-D
25 June 2013 St. Jude Medical has received CE mark clearance for its quadripolar device, the Quadra Assura MP cardiac resynchronisation therapy defibrillator...

ERT enhances electronic suicide risk assessment system
24 June 2013 ERT, a provider of patient safety solutions, has upgraded its electronic suicide risk assessment system AVERT to identify the occurrence of suicidal thoughts and actions among patients...

Medtronic's pump with Threshold Suspend reduces nocturnal hypoglycemia
24 June 2013 Medtronic is a step closer to developing an automated artificial pancreas for diabetics, as study results show the Threshold Suspend feature of its sensor-augmented insulin pump reduces...

Lophius joins NEU² with new project to address multiple sclerosis diagnosis
21 June 2013 Lophius Biosciences, a German developer of T cell-based diagnostic systems, has joined the NEU² consortium with a project aimed at developing its T-Track MS as a blood-based test that can...

Carestream receives FDA nod for DRX 2530C wireless digital radiography detector
21 June 2013 US-based dental and medical imaging systems provider Carestream Health has secured approval from the US Food and Administration (FDA) for its new wireless digital radiography...

Sorin Group wins CE mark approval for REPLY 200 family of pacemakers
20 June 2013 Sorin Group, a global medical device company, has received CE mark approval for the REPLY 200 family of pacemakers, which feature sleep apnea monitoring for better management of...

China's MicroPort Medical to acquire Wright's OrthoRecon business
20 June 2013 MicroPort Medical, a subsidiary of China-based MicroPort Scientific, has signed a definitive agreement with Wright Medical, a US-based orthopaedic company, to purchase Wright's OrthoRecon...

AngioDynamics’ NanoKnife System receives IDE approval for clinical study from US FDA
19 June 2013 US-based medical devices manufacturer AngioDynamics has secured Investigational Device Exemption (IDE) clearance from the US Food and Drug Administration to carry out a clinical study of...

Techne to acquire Bionostics to expand haematology product portfolio
19 June 2013 US-based Techne has agreed to buy Bionostics Holdings and its operating subsidiary Bionostics for $104m in cash as part of a strategy to expand its haematology products...

Staar Surgical’s Visian ICL with CentraFLOW technology wins approval in Korea, Argentina
18 June 2013 US-based ophthalmic products manufacturer Staar Surgical has secured regulatory clearances in South Korea and Argentina to sell its Visian implantable Collamer lens (ICL) with CentraFLOW...

Teva to expand respiratory portfolio with MicroDose Therapeutx acquisitions
18 June 2013 Israel-based pharmaceutical company Teva has signed a definitive agreement to acquire US-based pharmaceutical and drug delivery company MicroDose Therapeutx for $40m, as part of a strategy...

US FDA recommends manufacturers protect medical devices against cyber attacks
17 June 2013 The U.S. Food and Drug Administration has urged medical device makers, hospitals and other medical facilities to boost their protection systems against cyber attacks, which could affect how...

Mentor wins FDA clearance for MemoryShape breast implants
17 June 2013 US-based aesthetic medical products manufacturer Mentor Worldwide has received US Food and Drug Administration (FDA) clearance for its MemoryShape Breast...

Medtronic wins CE Mark approval for ReDuX plier device
14 June 2013 US-based medical device company Medtronic has received CE Mark clearance for its ReDuX plier, an instrument intended for use during...

China's Mindray Medical to acquire Zonare Medical for $105m
14 June 2013 China-based medical devices developer Mindray Medical International has signed a definitive agreement to acquire the US-based Zonare Medical Systems for...

MiMedx receives three new US patents for placental tissue allografts
13 June 2013 MiMedx Group, a US-based manufacturer of regenerative biomaterial products, has received three new patents for placental tissue allografts from the US Patent...

UK’s MHRA to regulate electronic cigarettes as medicines
13 June 2013 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is to regulate all products containing nicotine, including electronic cigarettes, as medicines to ensure product safety...

St Jude Medical receives FDA clearance for next generation of high-voltage devices
12 June 2013 Global medical device company St Jude Medical has received clearance from the US Food and Drug Administration (FDA) for its next-generation Ellipse and SJM Assura portfolio of...

Owen Mumford boosts efficiency and productivity with metrology training
12 June 2013 UK-based medical devices developer Owen Mumford is using dimensional metrology training to improve its production...

Teleflex secures FDA 510(k) clearance for dialysis catheters
11 June 2013 Teleflex, a US-based firm that provides medical devices for critical care and surgery, has secured US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis...

Yissum introduces new method to diagnose retinal micro-aneurysms
11 June 2013 The Hebrew University of Jerusalem's Yissum Research Development Company has introduced a novel method for detecting retinal micro-aneurysms that pose a high risk of leakage, a primary cause...

PLC Systems secures US patent for RenalGuard technology
10 June 2013 PLC Systems, a provider of medical device technologies, has secured a new method patent entitled 'Patient Hydration Method' from the US Patent and Trademark Office for its RenalGuard therapy...

St Jude Medical invests in pain management device firm Spinal Modulation
10 June 2013 St Jude Medical, a Minnesota-based medical device firm, has made a $40m equity investment in Spinal Modulation, a California-based firm that develops stimulator for spinal cord to treat chronic pain....

Woundcare firm Activa Healthcare launches compression hosiery selector app
07 June 2013 Activa Healthcare, a UK-based woundcare company, has introduced a new app for smartphones and tablets that enables nurses and pharmacists to easily evaluate which compression hosiery is the...

BioFire secures CE IVD Mark for FilmArray blood culture identification panel
07 June 2013 Utah-based BioFire Diagnostics has received the CE IVD Mark for its FilmArray blood culture identification (BCID) panel under the European Directive on in vitro diagnostic medical...

EBS Technologies receives CE Mark for brain stimulation device
06 June 2013 EBS Technologies, a medical device firm, has received CE Mark for Next Wave, a brain stimulation device that helps to treat neurological disorders caused by brain injury or...

Integrity Applications receives CE Mark approval for GlucoTrack DF-F device
06 June 2013 Israeli medical devices developer Integrity Applications has secured CE Mark approval for its GlucoTrack DF-F, a non-invasive blood glucose monitoring...

Clearbridge BioMedics’ ClearCell FX system improves cancer diagnosis
05 June 2013 Singapore-based Clearbridge BioMedics, in collaboration with development firm Cambridge Consultants, has unveiled a new generation of cancer diagnostic...

Medtronic receives FDA, CE clearances for new peripheral balloon catheter
05 June 2013 US-based Medtronic has received US Food and Drug Administration (FDA) and CE Mark clearances for its Pacific Plus percutaneous transluminal angioplasty (PTA)...

WHO approves PrePex non-surgical male circumcision device
04 June 2013 The World Health Organization (WHO) has approved the PrePex non-surgical male circumcision device developed by Israel-based Circ...

NuVasive releases MAS PLIF procedure into global market
04 June 2013 Global medical device company NuVasive has released its Maximum Access surgery posterior lumbar interbody fusion (MAS PLIF) procedure into the international...

Cochlear Americas receives FDA approval for waterproof hearing accessory
03 June 2013 Cochlear Americas, a provider of implantable hearing solutions, has received approval from the US Food & Drug Administration (FDA) for its waterproof hearing aid cover, which is compatible with...

GE Healthcare receives 510(k) clearance for Brivo Plus C-arm
03 June 2013 GE Healthcare has received FDA 510(k) clearance for its Brivo Plus C-arm, which is expected to offer a quality and affordable option for basic surgical...

May 2013

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Uscom to acquire medical device technology firm Pulsecor
31 May 2013 Australian medical devices company Uscom has entered into an agreement to acquire Pulsecor, a New Zealand-based medical device technology...

Medtronic's AUI device with Endurant II AAA stent graft system receives FDA approval
31 May 2013 US-based Medtronic is widening its portfolio of products for endovascular aortic repair in the US with two new medical devices following the FDA approval for the Endurant II Aorto-Uni-Iliac...

Covidien receives FDA 510(k) clearance for Nellcor pulse oximeters
30 May 2013 Covidien, a global provider of patient monitoring and respiratory care devices, has received US FDA 510(k) clearance with labelling for the use of its Nellcor pulse oximeters in newborn...

Abbott receives Health Canada licence for RealTime High Risk HPV test
30 May 2013 Global healthcare company Abbott has received a licence from the Medical Device Bureau of Health Canada for its RealTime High Risk HPV molecular diagnostic test, which is designed to detect...

iTraumaCare receives FDA nod for iTClamp hemorrhage control system
29 May 2013 Traumatic injury medical devices developer Innovative Trauma Care (iTraumaCare) has obtained 510(k) clearance from the US Food and Drug Administration (FDA) to market its iTClamp hemorrhage...

Biosense Technologies under FDA fire for urine analyser app
29 May 2013 India-based medical devices firm Biosense Technologies has come under the scrutiny of the US FDA for its recently-launched iPhone app uChek, which allows patients to analyse urine...

Valeant to acquire Bausch + Lomb for $8.7bn
28 May 2013 Canada's leading pharmaceutical company Valeant Pharmaceuticals has entered into a definitive agreement to acquire Bausch + Lomb Holdings, a US-based supplier of eye health products, for...

Biosensors International completes acquisition of Spectrum Dynamics
28 May 2013 Switzerland-based medical devices maker Biosensors International Group has completed the acquisition of substantially all assets of Spectrum Dynamics, a provider of functional...

Direct Flow Medical meets primary endpoint in Discover CE Mark trial
24 May 2013 Direct Flow Medical, a developer of transcatheter heart valve technologies, has met its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30...

Surfing-inspired nebuliser developed to treat cystic fibrosis with saltwater exposure
24 May 2013 Pharmaceutical company Parion Sciences and product development firm Cambridge Consultants have jointly developed a new surfing-inspired aerosol delivery system that can help people suffering...

Corgenix, Eli Lilly collaborate to develop diagnostic technology for oncology programme
23 May 2013 Specialised diagnostic kits manufacturer Corgenix has signed an agreement with Eli Lilly and Company, a US-based pharmaceutical company, to develop diagnostic technology in support of...

Abbott receives CE Mark approval for Xience Xpedition 48 coronary stent
23 May 2013 Medical devices producer Abbott has received CE Mark approval for the Xience Xpedition 48 Everolimus Eluting Coronary Stent System in...

FDA approves Hologic's C-View 2D imaging software for breast cancer screening
22 May 2013 The US Food and Drug Administration (FDA) has approved surgical products maker Hologic's new C-View 2D imaging software for...

Medtronic receives CE Mark for Export Advance aspiration catheter
22 May 2013 Medtronic has received the CE Mark for its Export Advance aspiration catheter and is planning to launch the product in Europe and other international markets....

Thoratec receives FDA nod for HeartMate II Pocket Controller
21 May 2013 Thoratec Corporation has received approval from the US Food and Drug Administration (FDA) to market the company's small, safe face of the HeartMate II LVAD System, the HeartMate II Pocket...

BioRestorative Therapies brings in Dexterity for brtxDISC stem cell therapy device production
21 May 2013 BioRestorative Therapies (BRT), a US-based stem cell biotechnology company, has brought in product design and bioengineering firm Dexterity to further the production of its proprietary...

Valtech Cardio treats first patients with percutaneous annuloplasty device without open-heart surgery
20 May 2013 Israel medical devices firm Valtech Cardio has completed treating first patients with severe mitral regurgitation (MR), using its Transfemoral Cardioband Annuloplasty...

Direct Flow Medical gets FDA nod to begin transcatheter aortic heart valve system trial
20 May 2013 Direct Flow Medical, a US-based developer of transcatheter heart valve technologies, has obtained the consent of United States Food and Drug Administration (FDA) to initiate the SALUS...

Study shows EOS imaging technology provides greater accuracy with lower radiation
17 May 2013 Paris-based developer of orthopaedic 2D and 3D imaging technologies EOS imaging has announced positive results from a study of its patented medical imaging system,...

St Jude Medical gets European approval for 3D imaging technology to assist stent placement
17 May 2013 Medical devices major St Jude Medical has obtained European approval for its 3D vessel reconstruction technology, which helps in assessing the condition of arteries to treat patients with...

Spinal Modulation Axium spinal cord stimulator reduces chronic neuropathic pain in study
16 May 2013 Spinal Modulation's Axium spinal cord stimulator (SCS) system has demonstrated that it significantly relieves chronic pain of patients suffering from complex regional pain syndrome (CRPS),...

Elixir Medical secures CE mark for DESolve scaffold system
16 May 2013 Elixir Medical has secured CE Mark certification for its DESolve Novolimus eluting bioresorbable coronary scaffold system, which is designed to degrade in one year's time, bringing the...

St Jude Medical enrols first patient in EnligHTN III trial to treat drug-resistant hypertension
15 May 2013 St Jude Medical has enrolled the first patient in its EnligHTN III trial to study the safety and performance of the second-generation EnligHTN renal denervation...

Devon Medical obtains CE mark for extriCARE portable would healing system
15 May 2013 Global medical device manufacturer and distributor Devon Medical has obtained CE mark approval for its portable would healing system,...

Sorin reveals positive clinical data for dual-chamber implantable cardioverter defibrillators
14 May 2013 Sorin Group has announced that its Sorin dual-chamber implantable cardioverter defibrillators (ICDs) have performed positively during a clinical...

TriStar Wellness acquires hemorrhage-control bandage developer HemCon
14 May 2013 US-based TriStar Wellness Solutions has acquired HemCon Medical Technologies, a developer of bleeding and wound management technologies for surgical, healthcare, consumer and military...

Medtronic's clinical trial data reveals drop in heart failure symptoms
13 May 2013 Global medical technology company Medtronic has demonstrated in a clinical trial that pacing the heart's lower chambers simultaneously using a cardiac resynchronisation therapy (CRT) device...

Active Space Technologies to develop robotic orthopaedic orthosis for elbow joint
13 May 2013 European firm Active Space Technologies has received a contract within the Eurostars Programme to develop a new robotic orthopaedic orthosis for elbow joints, based on aerospace...

Canadian Ministry of Health laboratory deploys Fluidigm's BioMark HD system for superbug detection
10 May 2013 The Saskatchewan Disease Control Laboratory (SDCL) of Canada has deployed BioMark HD technology developed by US-based Fluidigm for its laboratory in...

St. Jude Medical gets CE mark status for new device portfolio
10 May 2013 Global medical devices major St Jude Medical has received CE mark status for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and...

Lumenis partners with UK's Moorfields Eye Hospital to study SLT therapy in glaucoma patients
09 May 2013 Lumenis, a global medical laser company, has partnered with Moorfields Eye Hospital in the UK to establish its selective laser trabeculoplasty (SLT) technology as new gold standard for...

Elixir Medical gets FDA nod to enrol patients for eluting coronary stent system trial
09 May 2013 Elixir Medical has received the US Food and Drug Administration's (FDA) nod to begin the process of enrolling patients in its EXCELLA III clinical trial of its DESyne Nx Novolimus eluting...

Exactech obtains FDA approval for Gibralt occipital spine system
08 May 2013 Orthopaedic implant devices developer Exactech has obtained the US Food and Drug Administration (FDA) approval for its Gibralt occipital spine system, designed for complex cervical thoracic...

New medical device regulation proposals by EU do not ensure safety, say experts
08 May 2013 Medical device industry experts are expressing concerns that the new legislation to regulate medical devices currently being debated by European Union (EU) does not go far enough in ensuring...

NeuroSigma Monarch eTNS system obtains Health Canada approval
07 May 2013 NeuroSigma has obtained Health Canada approval for its Monarch external trigeminal nerve stimulation (eTNS) system to treat drug-resistant epilepsy (DRE), major depressive disorder (MDD)...

STAT-Diagnostica completes $17m financing round to develop diagnostic systems
07 May 2013 Spain-based STAT-Diagnostica has completed financing worth $17m to finalise the development of its Near Patient Testing diagnostic systems, and clinical validation of its first...

Clontech announces launch of RNA sequencing kit for compromised samples
03 May 2013 Clontech Laboratories, a subsidiary of Takara Bio, has launched an RNA sequencing kit for samples that are compromised or do not have polyadenylated...

Eventus gets CE mark designation for Octava Pink breast cancer test
03 May 2013 US-based Eventus Diagnostics has secured CE mark approval for its Octava Pink breast cancer test, which is used to confirm the presence of cancer in women whose mammography results were...

Cook Medical wins CE mark for PVA Foam Embolisation Particles
02 May 2013 The European Union (EU) has granted CE mark certification to Cook Medical's PVA foam embolisation particles for the treatment of symptomatic benign prostatic hyperplasia...

Medtronic announces global launch of multi-level spinal fusion procedure
02 May 2013 Global medical device firm Medtronic has launched its comprehensive minimally-invasive spinal fusion procedure, Mast Aligned, into the global...

St Jude wins CE mark for quadripolar cardiac resynchronisation therapy pacemaker
01 May 2013 The European Union has granted CE mark certification to St Jude Medical's quadripolar cardiac resynchronisation therapy pacemaker (CRT-P)....

Bayer to acquire Conceptus for $1.1bn
01 May 2013 Medical products giant Bayer is set to acquire US-based Conceptus for $1.1bn in order to broaden the company's contraception...

April 2013

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LipoScience commences clinical development of gut flora metabolite cardiovascular diagnostic test
30 April 2013 Diagnostic firm LipoScience, in partnership with Cleveland Clinic, has commenced the clinical development phase of a diagnostic test for cardiovascular disease based upon the gut flora...

Sorin to commence bioprosthetic valve study
30 April 2013 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to Sorin Group to initiate a prospective, non-randomised, multi-centre clinical study of...

FDA clears ResMed noninvasive COPD treatment device
29 April 2013 The US Food and Drug Administration has approved ResMed's home variable positive airway pressure (VPAP) device for minimising hospital...

Co-Diagnostics to acquire diagnostic probe technologies from DNA Logix
29 April 2013 American provider of personalised medicine and clinical diagnostics, Co-Diagnostics, is set to acquire certain genetic analysis technologies from DNA...

FDA accepts Cerus Intercept System PMA shell for review
26 April 2013 The US Food and Drug Administration (FDA) has accepted Cerus' proposed modular premarket approval (PMA) application shell for review of its Intercept blood system for...

Southern Spine launches minimally invasive spinal fixation system
26 April 2013 Southern Spine, a manufacturer of spinal implants and instruments, has introduced a new minimally invasive system for use in lumbar fusion...

FDA clears Andrew Technologies liposuction device
25 April 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Andrew Technologies' liposuction...

Cohera treats first patient in large and small bowel surgical sealant study
25 April 2013 Cohera Medical has treated the first patient in a clinical study of its Sylys surgical sealant, designed to reduce leaks in large and small bowel...

InspireMD wins FDA IDE for MGuard embolic protection stent study
24 April 2013 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to InspireMD to initiate a multi-centre, randomised clinical study of its MGuard embolic...

TriReme gets Shonin approval to distribute Glider PTCA catheter in Japan
24 April 2013 TriReme Medical has secured Shonin approval for its Glider PTCA catheter, through its Japanese partner Century Medical (CMI), allowing the company to distribute the product in...

Sanovas launches plug and play micro platform for endoscopic imaging market
23 April 2013 Sanovas, a US-based life science technology firm, has launched a new micro imaging platform, MicroCam, to revolutionise the endoscopic imaging...

Varian, Paul Scherrer Institute partner to study proton therapy strategies for cancer treatment
23 April 2013 Varian Medical Systems, a global manufacturer of medical devices and software for cancer treatment, has partnered with the Paul Scherrer Institute (PSI) to develop motion management techniques...

Aspect Imaging gets FDA clearance for M2 compact MRI system
22 April 2013 Global developer of compact high-performance magnets Aspect Imaging has obtained clearance from US Food and Drug Administration (FDA) for its M2 compact MRI system, developed for diagnostic...

BD Diagnostics, Diagenode introduce gastrointestinal tract infections assays in Europe
22 April 2013 BD Diagnostics and Diagenode have announced the European launch of their gastrointestinal tract infections...

Ventripoint wins CE mark for NRV application
19 April 2013 European notified body Intertek Semko has granted CE mark certification to Ventripoint Diagnostics' NRV application for analysis of 2-D ultrasound images for patients with non-specific heart...

FDA clears new MedShape soft tissue anchor
19 April 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to MedShape's new shape memory fixation...

BioFire seeks FDA approval for blood culture identification test
18 April 2013 US-based clinical diagnostics company BioFire Diagnostics has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA), for approval of its blood culture...

Cardiosonic completes first phase of patient enrolment in hypertension trial
18 April 2013 Cardiosonic has completed the first phase of patient enrolment in the first-in-man (FIM) clinical study of its high intensity, non-focused therapeutic ultrasound catheter system, used for...

OrbusNeich dual therapy stent trial meets primary endpoint
17 April 2013 China-based OrbusNeich has reported that its dual therapy stent met its primary endpoint and was found to be effective in controlling neointimal proliferation during a clinical...

Boston Scientific implants first US patient in MR Conditional pacing system trial
17 April 2013 Medical device manufacturer Boston Scientific has implanted the first US patient in a prospective, open-label, two-group randomised, multi-centre study of its MR Conditional pacing...

Thermo Fisher Scientific to purchase Life Technologies
16 April 2013 Thermo Fisher Scientific has entered into a definitive agreement to buy Life Technologies for $76.00 in cash per fully diluted common share, or $13.6bn, plus the assumption of net debt at...

Boston Scientific announces limited US launch of spinal cord stimulator
16 April 2013 Medical device manufacturer Boston Scientific has announced the limited launch of its spinal cord stimulator (SCS) system in the US, designed for the treatment of chronic...

Medtronic enrols first patients in PNS therapy study
15 April 2013 Medtronic has enrolled the first patients in a blind, controlled, multicentre, parallel arm study of its peripheral nerve stimulation (PNS), designed for the reduction of chronic,...

BD Medical announces US launch of anti-needlestick safety device
15 April 2013 BD Medical, a division of Becton, Dickinson and Company, has introduced an anti-needlestick safety device in the...

St. Jude wins CE mark for deep brain stimulation systems
12 April 2013 The European Union has granted CE mark certification to St. Jude Medical's deep brain stimulation (DBS) systems, designed for the treatment of primary and secondary dystonia, a...

FDA clears BD Diagnostics BD MAX C. difficile assay
12 April 2013 The US Food and Drug Administration (FDA) has approved BD Diagnostics' BD MAX C. difficile...

FDA clears Olympus 3D laparoscopic surgical video system
11 April 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Olympus' 3D laparoscopic surgical video system....

Quest Diagnostics introduces blood tests for rheumatoid arthritis
11 April 2013 US-based diagnostic information services provider Quest Diagnostics has launched new blood tests for the early diagnosis of autoimmune disorder rheumatoid arthritis (RA) that causes...

Medtronic real-time navigation system now available in the US, Canada
10 April 2013 Medtronic has announced the US and Canada launch of its real-time navigation system, designed for determining the proper location to place left-ventricular (LV) electrode leads for...

FDA clears Monteris MRI-guided ablation device for brain tumor treatment
10 April 2013 Monteris Medical has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its NeuroBlate system, designed for the treatment of brain tumors and other...

MagForce to commence NanoTherm Therapy device post-marketing study in Germany
09 April 2013 The German Federal Institute for Drugs and Medical Devices (BfArM) has granted approval to MagForce to commence a post-marketing clinical study in recurrent glioblastoma patients using...

Clarient introduces sequencing assay for solid tumors
09 April 2013 Clarient Diagnostic Services, a GE Healthcare company, has launched a new sequencing assay for the diagnosis of solid...

European physicians treat PAD patients using Cook Medical catheter
08 April 2013 Cook Medical's ultra low-profile micro-balloon catheter is being used by the European physicians to treat peripheral arterial disease (PAD) patients suffering from arterial lesions in the leg...

Samsung announces US launch of UGEO H60 ultrasound system
08 April 2013 Samsung Electronics' subsidiary Samsung Electronics America has launched an ultrasound system in the...

Advanced Brain Monitoring launches InsomniCare to manage sleep disorder
05 April 2013 US-based medical devices firm Advanced Brain Monitoring has launched a new system, InsomniCare, to manage...

FDA clears Lensar laser system for arcuate incisions in cataract surgery
05 April 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Lensar's laser system for making arcuate incisions on the periphery of the cornea during cataract...

Apollo Endosurgery wins CE mark for endoscopic suturing system
04 April 2013 The European Union has granted CE mark certification to Apollo Endosurgery's endoscopic surgical platform, designed to offer less invasive options during various endoscopic surgical...

Aptus Endosystems wins CE mark for thoracic-length Heli-FX system
04 April 2013 The European Union has granted CE mark certification to Aptus Endosystems' thoracic-length Heli-FX system for the treatment of thoracic aortic aneurysms...

Abiomed enrols first patient in percutaneous heart pump study
03 April 2013 Abiomed, a US-based provider of heart support technologies, has enrolled the first patient in an investigational device exemption (IDE) study of its percutaneous heart...

Medtronic receives FDA approval for temporary lung system
03 April 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Medtronic's temporary lung system, designed for use during open-heart surgical procedures that require a bloodless...

Mortara to buy Cardiac Science diagnostic cardiology product line
02 April 2013 Mortara Instrument, a provider of ECG technology, has entered into a definitive agreement to buy Cardiac Science's diagnostic cardiology product line for an undisclosed...

K2M introduces Venado foam strips, Venado granules bone graft systems
02 April 2013 Spinal device company K2M has launched its Venado foam strips and Venado granules bone graft systems for the treatment of complex spinal pathologies and for minimally invasive...

March 2013

Top

Maquet launches new retractor to improve cardiothoracic access through small incisions
28 March 2013 Global provider of medical systems, Maquet, has launched a new retractor that could maximise cardiothoracic access during minimally invasive revascularisation...

Bonesupport announces commencement of bone void filler study
28 March 2013 Bonesupport has announced the commencement of a study comparing Cerament bone void filler with autologous bone taken from the patient's iliac...

BioControl gets FDA clearance for third phase clinical study of CardioFit
27 March 2013 Israeli medical devices firm BioControl Medical has obtained US Food and Drug Administration (FDA) clearance to expand its increase of vagal tone in heart failure (INOVATE-HF) study of...

FDA clears Tenex Health TX1 tissue removal system
27 March 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Tenex Health's TX1 tissue removal system for use in general, orthopedic, laparoscopic, plastic and reconstructive...

Barts enrols first patients in resistant hypertension treatment trial
26 March 2013 St Bartholomew's and the London NHS Trust (Barts) in the UK, has enroled the first patients in the ROX Medical's international, controlled clinical study of ROX FLOW catheter...

Miracor treats first German STEMI patient using PISCO system
26 March 2013 Austria-based Miracor Medical Systems has treated the first German patient using its pressure-controlled intermittent coronary sinus occlusion (PICSO) system, designed to treat acute heart...

Boston Scientific presents clinical endpoint data from Platinum China trial
25 March 2013 Boston Scientific has presented clinical endpoint data from a prospective, randomised clinical study of its Promus Element everolimus-eluting platinum chromium (PtCr) coronary stent system, for...

FDA approves GE Healthcare molecular imaging agent for cardiac risk evaluation
25 March 2013 The US Food and Drug Administration (FDA) has approved a new indication for GE Healthcare's molecular imaging agent for the evaluation of cardiac risk in heart failure...

FDA grants conditional approval to Sorin cardiac resynchronisation therapy system
22 March 2013 The US Food and Drug Administration (FDA) has granted conditional approval to Sorin Group to conduct an investigational device exemption (IDE) clinical study of its heart failure management...

RTI Biologics reports positive results from BioCleanse-processed BTB allograft study
22 March 2013 RTI Biologics, a provider of orthopedic and biologic implants, has reported positive results from a randomised, prospective clinical study of its BioCleanse-processed bone-patellar...

St Jude reports positive results from transcatheter PFO closure device study
21 March 2013 US-based medical technology company St Jude Medical has reported positive results from a prospective, controlled clinical study of its transcatheter patent foramen ovale (PFO) closure...

AcuFocus seeks FDA approval for near vision loss restoration device
21 March 2013 US-based AcuFocus has submitted the KAMRA intra-corneal inlay's final premarket approval application (PMA) module to the US Food and Drug Administration...

St Jude reports positive results from Trifecta biological pericardial aortic valve study
20 March 2013 St Jude Medical, a US-based developer of medical technologies, has reported positive results from a multi-centre, prospective study of its Trifecta biological pericardial aortic valve, designed...

VertiFlex treats first patient with Totalis Direct Decompression system
20 March 2013 VertiFlex, a US-based developer of minimally invasive spinal solutions, has treated the first patient using its Totalis Direct Decompression system, designed for the treatment of lumbar...

ROX enrols first UK patients in resistant hypertension treatment trial
19 March 2013 ROX Medical, a US-based provider of treatment for hypertension and chronic obstructive pulmonary diseases, has enrolled the first UK patients in a controlled, randomised study of its ROX...

ETView wins Chinese approval for VivaSight-SL airway management device
19 March 2013 The Chinese State Food and Drug Administration (SFDA) ihas cleared the pre-marketing notification application for ETView Medical's VivaSight-SL airway management...

InspireMD wins CE mark for Nitinol carotid embolic protection stent
18 March 2013 The European Union has granted CE mark certification to InspireMD's Nitinol carotid embolic protection stent (EPS), which is designed to offer procedural and post-procedural distal...

Oculus completes patient follow-up in scar management study
18 March 2013 Oculus Innovative Sciences, a US-based developer of wound care devices, has completed a 112-day patient follow-up in a double-blinded, comparative and randomised clinical study of its...

New bionic eye device found to treat vision loss in RP patients
15 March 2013 A new bionic eye, Argus II Retinal Prosthesis System developed by Second Sight Medical Products, is set to enable blind people suffering from a group of conditions called retinitis pigmentosa...

Volcano introduces Valet microcatheter in US, Europe
15 March 2013 Volcano, a US-based developer of precision-guided therapy tools for the diagnosis of coronary and peripheral vascular diseases, has announced the US and European launch of its Valet...

Direct Flow Medical transcatheter aortic valve system demonstrates low mortality
14 March 2013 Direct Flow Medical, a US-based developer of transcatheter heart valve technologies, has presented 30-day and six-month outcomes from a prospective, multicentre study of its Direct...

FDA clears Quidel molecular RSV + hMPV assay
14 March 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus...

Cordis purchases Flexible Stenting Solutions
13 March 2013 Cordis, an interventional vascular technology developer and part of the Johnson & Johnson family of companies, has purchased US-based Flexible Stenting Solutions for an undisclosed...

Abbott presents three year study data of bioresorbable vascular scaffold
13 March 2013 Abbott has presented three-year study data from a prospective, single-arm clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device for the treatment of patients with...

Abbott reports mitral regurgitation treatment device study data
12 March 2013 Global healthcare company Abbott has reported study data from a clinical trial of its catheter-based MitraClip System for the treatment of mitral regurgitation...

St Jude introduces FFR and OCT Ilumien Optis system in Japan
12 March 2013 Medical technology company St Jude Medical has announced the Japanese launch of a 3D vessel reconstruction system to capture a physiological and anatomical view of the coronary vessels and...

St. Jude implants first patient in self-expanding occlusion device trial
11 March 2013 St. Jude Medical has implanted the first patient in a prospective, randomised, multi-centre study of its self-expanding occlusion device for the prevention of stroke in patients with...

Medtronic wins CE mark for Attain Performa portfolio of quadripolar leads
11 March 2013 The European Union has granted CE mark certification to Medtronic's Attain Performa portfolio of quadripolar leads....

Health Canada approves CellAegis autoRIC device for remote ischemic conditioning
08 March 2013 Health Canada has granted marketing authorisation to CellAegis Devices' autoRIC device for remote ischemic conditioning...

Medtronic seeks FDA approval to commence renal denervation system study
08 March 2013 US-based medical technology company Medtronic has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA), seeking approval to initiate...

Boston Scientific introduces new sizes of Rubicon catheter in US
07 March 2013 Medical device manufacturer Boston Scientific has announced the US launch of its Rubicon support catheter in 0.035in (0.89mm) and 0.018in (0.46mm)...

Cohera treats first patient in US no-drain clinical study
07 March 2013 Cohera Medical, a developer of absorbable surgical adhesives and sealants, has treated the first patient in a randomised and controlled US no-drain clinical study of its internal surgical...

FDA grants conditional approval to CircuLite micro-blood pump
06 March 2013 The US Food and Drug Administration (FDA) has granted conditional approval to CircuLite to conduct an investigational device exemption (IDE) feasibility clinical study on its micro-blood...

MagDev develops pain and inflammation management device
06 March 2013 MagDev Research has developed a new handheld device to reduce inflammation and lower pain levels with no reported side...

Brain Cool announces Phase One clinical trial of medical brain cooling system
05 March 2013 Brain Cool, a subsidiary of Swedish medical device company Dignitana, has announced a Phase I clinical trial of its medical brain cooling system, to treat stroke...

ROX Medical enrols first patients in resistant hypertension treatment procedure
05 March 2013 ROX Medical, an early phase medical device company, has enrolled the first two Irish patients in a controlled study of its minimally invasive catheter procedure for the treatment of...

Aesculap introduces gravitational shunt valve for hydrocephalus
04 March 2013 Aesculap, a B Braun company, has introduced a gravitational shunt valve to provide surgeons with a new treatment option for patients with...

CeQur presents initial data of PaQ insulin delivery device
04 March 2013 CeQur has presented initial data from a clinical study of its PaQ insulin delivery device, designed for use in patients with type 2...

Medtronic wins CE mark for Engager transcatheter aortic valve implant
01 March 2013 The European Union has granted CE mark approval to Medtronic's new transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, for the treatment of patients...

FDA approves On-X Life prosthetic heart valve with anatomic sewing ring
01 March 2013 The US Food and Drug Administration (FDA) has approved On-X Life Technologies' new On-X aortic prosthetic valve with anatomic sewing...

February 2013

Top

Expanding Orthopedics initiates pedicle screw system study
28 February 2013 Spinal device company Expanding Orthopedics has started enrolling patients in a multi-centre, post-market clinical study of its pedicle screw system in...

ReShape completes patient enrolment in non-surgical weight loss device trial
28 February 2013 US-based medical device manufacturer ReShape Medical has finished enrolling patients in a randomised, pivotal clinical trial of its non-surgical weight loss device for the treatment of...

PneumRx treats first US patient using emphysema treatment therapy
27 February 2013 PneumRx has treated the first US patient in a clinical study of its minimally invasive medical implant for the treatment of patients with severe emphysema, including those with heterogeneous...

Medtronic to conduct transcatheter pulmonary valve early feasibility study
27 February 2013 The US Food and Drug Administration (FDA) has granted approval to Medtronic to conduct an early feasibility study on its Native Outflow Tract transcatheter pulmonary valve (TPV) to treat...

Medtronic wins FDA approval for new Resolute stent sizing options
26 February 2013 The US Food and Drug Administration (FDA) has approved Medtronic's new sizes of its Resolute Integrity drug-eluting stent for the treatment of coronary artery disease in patients with...

CardioNet, IMEC to develop cardiac monitoring devices
26 February 2013 Wireless medical technology and research services company CardioNet has entered into a multi-year agreement with the Belgium-based nanoelectronics research centre IMEC and its Dutch affiliate...

Lab21, IntegraGen collaborate to develop colorectal cancer assay
25 February 2013 Diagnostic products and services provider Lab21 and IntegraGen have entered into a partnership agreement for the development of a microRNA assay for colorectal...

Digirad introduces Breast Imaging Accessory for spotting lesions in breast tissue
25 February 2013 Diagnostic imaging products developer Digirad has introduced its Molecular Breast Imaging accessory, designed as an adjunctive diagnostic for use with the company's ergo imaging...

Ventrix presents cardiac repair scaffold pre-clinical study results
22 February 2013 San Diego-based Ventrix has reported pre-clinical study results of its biomaterial scaffold for the repair of damaged...

Diagnovus introduces molecular diagnostic assay for diffuse large B-Cell lymphoma
22 February 2013 US-based molecular diagnostic company Diagnovus has introduced a gene expression assay for patients with diffuse large B-cell lymphoma (DLBCL), a cancer of B...

Covidien completes patient enrolment in iliac stent clinical studies
21 February 2013 Healthcare products company Covidien has finished enrolling patients in its prospective, multinational, multicentre iliac stent clinical study...

Australia, Colombia clear ElectroCore vagus nerve stimulator
21 February 2013 US-based healthcare company ElectroCore has received regulatory approvals for its non-invasive vagus nerve stimulation therapy from the Therapeutic Goods Administration in Australia and...

Exact submits colorectal cancer screening test second module PMA to FDA
20 February 2013 Molecular diagnostics company Exact Sciences has filed the second module of a premarket application (PMA) seeking approval from the US Food and Drug Administration (FDA) for its noninvasive...

InSightec to initiate ExAblate Neuro device trial for essential tremor
20 February 2013 The US Food and Drug Administration (FDA) has granted approval to InSightec to initiate a multi-centre, double blinded Phase III clinical study of its ExAblate Neuro device for treating...

Biotronik wins CE mark for Ilesto 7 CD/CRT-D series
19 February 2013 The European Union has granted CE mark certification to Biotronik's Ilesto 7 implantable cardioverter-defibrillator / cardiac resynchronisation therapy defibrillator (ICD/CRT-D)...

MDxHealth reports prostate cancer assay study results
19 February 2013 Molecular diagnostic company MDxHealth has reported results from two studies of its DNA methylation-based assay, designed for the diagnosis and subsequent treatment of prostate cancer (PCa)...

ReCor begins post-market study of minimally invasive ultrasound device
18 February 2013 ReCor Medical has begun a post-market study of its new minimally invasive ultrasound device used to treat patients with resistant high blood...

St Jude to initiate study of renal denervation system
18 February 2013 US-based medical technology developer St Jude Medical has announced a study evaluating whether its multi-electrode renal denervation technology can provide additional benefits beyond a reduction...

Kimberly-Clark introduces cooled radiofrequency system for cervical joint pain
15 February 2013 Kimberly-Clark has introduced a cooled radiofrequency (RF) system to treat patients with pain in the cervical facet joint of the...

Blue Belt treats first US patients using robotic orthopedic surgical system
15 February 2013 Medical technology company Blue Belt Technologies has performed the three first US unicondylar knee replacement (UKR) surgeries using its robotic orthopedic surgical...

FDA clears Medtronic MR-Conditional pacemaker
14 February 2013 The US Food and Drug Administration (FDA) has approved Medtronic's new MR-Conditional pacemaker for use with MRI...

US FDA clears Paragonix single-use organ preservation device
14 February 2013 The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification (PMA) application of Paragonix Technologies' single-use organ preservation...

Fresenius Medical launches WetAlert wireless wetness detector
13 February 2013 Dialysis products and services provider Fresenius Medical Care has launched its WetAlert wireless wetness detector to prevent blood loss during home...

Boston Scientific wins CE mark for polymer drug-eluting stent system
13 February 2013 The European Union has granted CE mark certification to a new polymer-based drug-eluting stent (DES) system, developed by Boston Scientific to treat patients with coronary artery...

St Jude presents additional study data of transcatheter PFO closure device
12 February 2013 US-based medical technology developer St Jude Medical has presented additional data from a prospective, randomised, event driven-study of its transcatheter patent foramen ovale (PFO) closure...

Australia clears Cytomedix Angel cPRP system
12 February 2013 The Australian Therapeutic Goods Administration (TGA) has approved Cytomedix's Angel cPRP system for the preparation of platelet rich plasma (PRP) from a sample of whole...

FDA clears Planmed low dose orthopedic imaging system
11 February 2013 The US Food and Drug Administration (FDA) has granted 510(k) approval to Planmed's low-dose orthopedic imaging system to provide fast 3D imaging of subtle extremity fractures that have been...

EnteroMedics announces vagal blocking therapy trial data
11 February 2013 EnteroMedics has reported clinical study results of its VBLOC vagal blocking therapy used for the treatment of...

Covidien releases mechanical thrombectomy device study results
08 February 2013 Healthcare products company Covidien has presented two-year clinical study results of its mechanical thrombectomy device, used for treating acute ischemic...

FDA approves Smiths Medical multi-therapy infusion system
08 February 2013 The US Food and Drug Administration (FDA) has granted 510(k) approval to Smiths Medical's multi-therapy ambulatory infusion...

TherOx commences SSO2 therapy device IDE study
07 February 2013 US-based medical device company TherOx has commenced an investigational device exemption (IDE) pilot study of its new supersaturated oxygen (SSO2) therapy...

Zoll Medical wins Japanese approval for intravascular temperature management device
07 February 2013 The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted Shonin approval to Zoll Medical's intravascular temperature management (IVTM) system for use in neurologically...

Kips Bay implants first US patient in eSVS Mesh trial
06 February 2013 US-based medical device company Kips Bay Medical has implanted the first US patient in a multi-centre, randomised clinical study of its eSVS...

ALung wins Health Canada approval for respiratory dialysis device
06 February 2013 Health Canada has granted license to ALung Technologies' minimally invasive device for treating patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome...

Pentax announces availability of pediatric-sized colonoscope in Canada
05 February 2013 Health Canada has granted license to Pentax Medical's paediatric size (11.6mm) colonoscope for use in diagnostic colonoscopy procedures for colorectal cancer screening and therapeutic...

St Jude implants first patient in European Portico heart valve trial
05 February 2013 Medical technology developer St Jude Medical has implanted the first patient with a 25mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing European...

EDAP seeks US approval for ultrasound-guided prostate cancer diagnostic device
04 February 2013 EDAP TMS has submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) seeking approval to use its high intensity focused ultrasound (HIFU) device to...

Intersect ENT commences steroid-eluting implant clinical trial
04 February 2013 US-based Intersect ENT has commenced a blinded, multi-centre, prospective, randomised clinical study of its new steroid delivery implant for treating patients with recurrent sinus...

Velomedix enrols first patient in therapeutic hypothermia device trial
01 February 2013 Velomedix has enrolled the first patient in a prospective, multi-centre clinical study of its rapid therapeutic hypothermia system for treating acute myocardial infarction (AMIs or heart...

Samsung Electronics buys US-based computed tomography company
01 February 2013 Technology giant Samsung Electronics' subsidiary Samsung Electronics America has purchased Massachusetts-based computed tomography (CT) company NeuroLogica as part of a move expand its...

January 2013

Top

St Jude Medical enrols first patient in renal denervation device trial
31 January 2013 US-based medical technology developer St Jude Medical has enrolled the first patient in a clinical trial of its multi-electrode renal denervation technology for treating patients...

Solta Medical to buy US-based surgical body shaping devices provider
31 January 2013 California-based medical aesthetics company Solta Medical has announced that it will purchase Colorado-based Sound Surgical Technologies for $25.5m in common stock and $5m in...

Direct Flow Medical wins CE mark for transcatheter aortic heart valve system
30 January 2013 The European Union has granted CE mark certification to Direct Flow Medical's transcatheter aortic heart valve system, featuring a double-ring design to create a tight and durable seal around...

Dfine introduces ultra-high viscosity bone cement for treating complex fractures
30 January 2013 US-based medical technology company Dfine has introduced its new energy-responsive, ultra-high viscosity StabiliT ERX bone cement for use with the company's vertebral augmentation...

Medtronic initiates neurostimulation therapy device trial
29 January 2013 US-based medical technology company Medtronic has initiated a prospective, open-label, parallel-group clinical study of its neurostimulation therapy device for treating patients with chronic...

AngioScore introduces new size of AngioSculpt PTA scoring balloon catheters
29 January 2013 US based endovascular company AngioScore has introduced its new 100mm length AngioSculpt PTA scoring balloon catheters, designed to treat complex lesions in patients with peripheral artery...

Covidien gets European approval for EverFlex self-expanding peripheral stent
28 January 2013 Healthcare products company Covidien has obtained European CE mark approval for its EverFlex self-expanding peripheral stent, to be used with its accompanying Entrust delivery...

Medtronic wins CE mark for Complete SE stent for use in lower extremities
28 January 2013 The European Union has granted CE mark certification to Medtronic's self-expanding vascular stent for use in lower extremities, including superficial femoral arteries (SFA) and proximal...

SPR Therapeutics wins CE mark for chronic shoulder pain management device
25 January 2013 The European Union has granted CE mark certification to a peripheral nerve stimulation (PNS) device developed by the US-based SPR Therapeutics for the minimally-invasive treatment of...

AngioDynamics to buy soft tissue ablation system from Microsulis
25 January 2013 US-based minimally-invasive medical device developer AngioDynamics has entered into a deal to purchase UK-based medical device company Microsulis Medical's microwave ablation...

Inova introduces rapid-response chemiluminescent analyser for autoimmunity testing
24 January 2013 Medical diagnostic tests developer Inova Diagnostics has introduced a rapid-response chemiluminescent analyser with Quanta Flash reagents for autoimmune disease diagnostic...

Medtronic completes patient enrolment for IN.PACT Admiral drug-eluting balloon study
24 January 2013 US-based medical technology company Medtronic has finished enrolling patients for clinical trials of its IN.PACT Admiral drug-eluting balloon device for treating patients with peripheral...

CorMatrix Cardiovascular completes safety trial on CorMatrix ECM technology
23 January 2013 CorMatrix Cardiovascular has completed a trial of its CorMatrix ECM technology and confirmed safety of its usage to close the pericardium of patients undergoing postoperative coronary artery...

FDA clears Bioness foot drop system for paediatric use
23 January 2013 American neuromodulation device developer Bioness has obtained US Food and Drug Administration (FDA) approval for its L300 neurostimulation system indicated for the treatment of children...

Stryker to acquire Chinese orthopaedic products maker Trauson for $764m
22 January 2013 Global medical device manufacturer Stryker is set to acquire Chinese orthopaedic products manufacturer Trauson for $764m in an all-cash...

St Jude Medical gets CE Mark approval for left atrial appendage occluder
22 January 2013 St Jude Medical has obtained European CE Mark approval for its left atrial appendage (LAA) occluder, Amplatzer Amulet, which helps to reduce the risk of an ischemic stroke by sealing off the...

St Jude Medical wins CE mark for Intracardiac Echocardiography catheter
21 January 2013 The European Union has granted CE mark certification to St Jude Medical's Intracardiac Echocardiography (ICE) catheter for providing improved control and maneuverability while performing...

Integra gets EU clearance for diabetic wound management device
21 January 2013 Global medical devices firm Integra LifeSciences has obtained clearance from the European Union for its device aimed at treating diabetic foot and leg...

Covidien introduces balloon-based catheter device for treating resistant hypertension
18 January 2013 Healthcare products company Covidien has introduced an over the wire balloon-based irrigated catheter device to treat patients who are resistant to medical management of...

Sanovas seeks US approval for miniaturised interventional catheter
18 January 2013 Sanovas, a US-based life science technology company, has submitted an application to the US Food and Drug Administration (FDA) seeking approval to use its miniaturised interventional catheter...

Medtronic introduces FlexCath Advance Steerable Sheath in US
17 January 2013 Medtronic has announced the US launch of the FlexCath Advance Steerable Sheath, which facilitates easier access to reach the inferior veins of the heart when delivering and positioning...

Boston Scientific treats first US patient using Blazer Open-Irrigated Catheter
17 January 2013 Medical device manufacturer Boston Scientific has treated the first US patient with symptomatic, drug refractory paroxysmal atrial fibrillation in a clinical trial of its Blazer...

GI Dynamics begins EndoBarrier liner pivotal trial in the US
16 January 2013 GI Dynamics has a commenced a US pivotal trial of its non-surgical device that is designed to treat patients with obesity and uncontrolled type 2...

CardioFocus to complete patient enrollment for HeartLight trial this year
16 January 2013 Medical device manufacturer CardioFocus will complete full patient enrolment in a US pivotal clinical trial of its catheter ablation system in...

Covidien enrolls first patient in acute ischemic stroke study
15 January 2013 Healthcare products company Covidien has enrolled the first patient in a controlled, multi-centre, prospective, randomised clinical trial to examine the adjunctive use of its...

ElectroCore begins patient enrollment for chronic migraine prevention study
15 January 2013 US-based healthcare company ElectroCore has begun enrolling patients in a clinical trial of its non-invasive device designed for preventing chronic...

Medtronic enrols first patient in CRT-P device trial
14 January 2013 Medtronic has enrolled the first patient in a controlled, double-blind, prospective, randomised clinical trial to evaluate the effectiveness of its Consulta cardiac...

Testing a portion of saliva gland could diagnose Parkinson's disease
14 January 2013 The testing of a portion of saliva gland could diagnose Parkinson's disease, according to a Mayo Clinic and Banner Sun Health Research Institute...

FDA approves Brainsway Deep TMS device for treating depression
11 January 2013 The US Food and Drug Administration (FDA) has approved Brainsway's Deep transcranial magnetic stimulation (TMS) device for use in patients with depression who have failed to respond...

Abbott wins CE mark for high sensitive troponin assay
11 January 2013 The European Union has granted CE mark approval to Abbott's chemiluminescent microparticle immunoassay (CMIA), designed to quickly evaluate potential heart...

Velomedix to expand therapeutic hypothermia system pilot study into Canada
10 January 2013 Health Canada has approved Velomedix's pilot study of its rapid therapeutic hypothermia system, designed for use in patients with acute myocardial infarctions (AMIs or heart...

Abbott commences ABSORB III drug eluting bioresorbable vascular scaffold trial
10 January 2013 Abbott has commenced a clinical trial of its drug eluting bioresorbable vascular scaffold (BVS) device, designed to treat patients with coronary artery...

CardioKinetix enrols first patient in PARACHUTE IV ventricular partitioning device study
09 January 2013 Medical device company CardioKinetix has enrolled the first patient in a US pivotal trial of its minimally invasive ventricular partitioning device, designed to treat patients with heart...

Australia, Canada clear SinuSys sinus dilation system
09 January 2013 Sinus health company SinuSys has obtained regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its sinus dilation system, designed for the treatment...

Thoratec to commence continuous-flow left ventricular assist device study
08 January 2013 The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to Thoratec to initiate a feasibility clinical study of its continuous-flow left ventricular...

FDA clears BioPhotas light therapy device for pain management and certain skin conditions
08 January 2013 The US Food and Drug Administration (FDA) has cleared BioPhotas' patented biophotonic medical device, designed to treat acne, muscle and joint pain, muscle and joint stiffness, muscle...

EndoChoice to merge with Israel-based endoscopy technology developer
07 January 2013 US gastrointestinal endoscopy company EndoChoice has entered into an agreement to merge with Israeli company Peer...

FDA clears Tensys continuous non-invasive hemodynamic patient monitor
07 January 2013 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Tensys Medical's new continuous, non-invasive hemodynamic patient monitoring system, designed for use in operating...

FDA approves Abbott drug eluting stent for symptomatic heart disease treatment
04 January 2013 The US Food and Drug Administration (FDA) has approved Abbott's drug eluting stent system, which is designed to improve coronary artery luminal diameter in patients with symptomatic heart...

BG Medicine wins CE mark for automated Galectin-3 blood test
04 January 2013 The European Union has granted CE mark approval to BG Medicine's automated blood test, designed for use in patients with chronic heart...

FDA clears Dune Medical breast cancer detection device
03 January 2013 The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Dune Medical Devices' intra-operative tissue assessment tool for breast cancer detection, based on a...

Halt Medical wins funding for Acessa system commercialisation
03 January 2013 Publicly traded private equity firm American Capital has granted $15m finance to support the commercialisation of Halt Medical's minimally invasive medical device, designed for treating...

DJO purchases medical device company Exos
02 January 2013 DJO, a wholly-owned subsidiary of DJO Finance (DJOFL), has completed the acquisition of US-based medical device company Exos for an undisclosed...

Texas hospital adopts Mazor Robotics surgical guidance system
02 January 2013 Mazor Robotics's surgical guidance system, designed for use in spine procedures, has been purchased by Texas-based Foundation Surgical Hospital (FSH), a provider of surgical procedures and...

December 2012

Top

St Jude enrols first patient in ILUMIEN I observational clinical study
21 December 2012 St Jude Medical has enrolled the first patient in its observational clinical study designed to demonstrate that intravascular imaging technology, when combined with St Jude's...

FDA approves Angiotech's Bio-Seal Lung Biopsy Tract Plug system
21 December 2012 The US Food and Drug Administration (FDA) has approved Angiotech Pharmaceuticals' proprietary biopsy device system, designed to prevent air leaks that can lead to a collapsed lung or...

Molecular Devices introduces MetaMorph super-resolution system
20 December 2012 Molecular Devices, a provider of bioanalytical measurement systems, has introduced a super-resolution system with synchronised image acquisition and real-time image processing...

Riverside Methodist treats first US patient using Cook drug-eluting peripheral stent
20 December 2012 Riverside Methodist Hospital, a not-for-profit, faith-based healthcare system in Columbus, Ohio, has implanted the first US patient with Cook Medical's drug-eluting peripheral stent, designed...

NeoGenomics announces US launch of Barrett's Esophagus FISH assay
19 December 2012 Cancer-focused genetic testing services provider NeoGenomics has announced the US launch of its fluorescent in situ hybridisation (FISH) test, designed for monitoring patients with...

UMCG treats first patient using minimally invasive lung volume reduction coil
19 December 2012 University Medical Centre Groningen (UMCG) has treated the first patient in an IDE pivotal trial of a minimally invasive lung volume reduction coil designed to relieve breathing difficulty...

Boston Scientific implants first patient with Ingevity pacing leads
18 December 2012 Boston Scientific has implanted the first patient with a new version of its pacing leads in a multi-centre, non-randomised prospective clinical...

Biosensors enrols first patient in polymer-free drug-coated stent trial
18 December 2012 Biosensors International Group has enrolled the first patient in a clinical trial of its polymer-free drug-coated stent (DCS), designed for use in patients with high risk of...

Insulet wins FDA approval for new tubeless insulin pump
17 December 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Insulet's new version of tubeless insulin pump, designed for use in patients with...

Handsome secures funding for spinal pain relief products development
17 December 2012 South Manchester-based Handsome, a developer of spinal pain relief products, has secured £250,000 from The North West Fund for Biomedical, managed by SPARK...

The Medicines Company to buy hospital-focused specialty pharmaceutical company
14 December 2012 The Medicines Company has agreed to purchase Incline Therapeutics, a hospital-focused specialty pharmaceutical company, for an upfront payment of...

Cohera to commence TissuGlu surgical adhesive no-drain clinical trial in US
14 December 2012 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to Cohera Medical to initiate the first no-drain clinical trial of its internal surgical...

Microsulis wins FDA approval for upgraded microwave tissue ablation applicator
13 December 2012 The US Food and Drug Administration (FDA) has approved Microsulis Medical's upgraded version of minimally invasive microwave tissue ablation...

Precision Spine wins FDA approval for minimally invasive spinal fixation system
13 December 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to Precision Spine's minimally invasive spinal fixation system for use with the company's S-LOK pedicle screw...

Physician's Technology introduces new digital joint pain relief device
12 December 2012 Physician's Technology has launched a new digital medical hands-free device to rejuvenate and revitalise painful...

BG Medicine wins CE mark for cardiovascular risk assessment blood test
12 December 2012 The European Union has granted CE mark approval to BG Medicine's diagnostic blood assay, designed to identify individuals at high-risk for near-term major cardiovascular events including...

Boston Scientific wins CE mark for spinal cord stimulator system
11 December 2012 The European Union has granted CE mark approval to Boston Scientific's spinal cord stimulator (SCS) system, designed to provide improved pain relief in chronic pain...

Nanosphere wins FDA approval for infectious C difficile test
11 December 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to Nanosphere's infectious C difficile test for use on the sample-to-result Verigene...

Functional Neuromodulation implants first US patient with deep brain stimulation system
10 December 2012 Functional Neuromodulation has implanted the first US patient with a deep brain stimulation (DBS) system in a randomised double-blind controlled...

NanoString breast cancer assay meets primary and secondary endpoints
10 December 2012 US-based life sciences company NanoString Technologies' breast cancer assay, based on the PAM50 gene expression signature, has met its primary and secondary endpoints in a second...

Colibri Heart implants first patient with Colibri transcatheter aortic heart valve
07 December 2012 US-based Colibri Heart Valve has implanted the first patient with its proprietary transcatheter aortic valve implantation (TAVI) system, as part of first-in-human feasibility...

Mauna Kea wins CE mark for optical biopsy probe use in urological applications
07 December 2012 The European Union has granted CE mark approval to Mauna Kea Technologies' optical biopsy probe for use in urological...

Sorin receives Japanese approval for bioprosthetic heart valve
06 December 2012 The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved Sorin Group's bioprosthetic heart valve, designed for replacing diseased, damaged or malfunctioning native or...

Epigenomics blood-based colorectal cancer detection test meets sensitivity endpoint
06 December 2012 German-American cancer molecular diagnostics company Epigenomics' blood-based colorectal cancer (CRC) detection test was found to be non-inferior in sensitivity to fecal immunochemical...

FDA partners with MDIC to advance regulatory science for medical devices
05 December 2012 The US Food and Drug Administration (FDA) has joined forces with the new Medical Device Innovation Consortium (MDIC), created by biomedical science trade association LifeScience Alley, to create...

Volcano to purchase Crux Biomedical
05 December 2012 Volcano, a manufacturer of precision guided therapy tools, has entered into an agreement to purchase US-based Crux Biomedical for $36m in...

Medtronic wins CE mark for minimally invasive continuous glucose monitor
04 December 2012 The European Union has granted CE mark approval to Medtronic's minimally invasive continuous glucose monitor (CGM) for use in hospital critical care units...

Silicone breast implants with spider silk-based coating found to reduce side-effects
04 December 2012 AMSilk has reported that the silicone breast implants with spider silk-based coating have been shown to reduce immune system-based side-effects in preclinical...

Boston Scientific enrols first patient in coronary stent system trial
03 December 2012 Boston Scientific has enrolled the first patient in a clinical trial to assess the safety and effectiveness of its coronary stent system, designed to treat atherosclerotic coronary...

KRAS mutation screening in colorectal cancer patients is cost-effective: Study
03 December 2012 The US healthcare system could save over $600m every year by avoiding unnecessary use of medicines in colorectal cancer (CRC) patients through determination of their KRAS status, according to...

November 2012

Top

St Jude wins CE mark for Assura family of implantable defibrillators
30 November 2012 The European Union has granted CE mark to St Jude Medical's Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)....

China clears Edwards Lifesciences mitral valve replacement therapy
30 November 2012 The China's State Food and Drug Administration (SFDA) has granted approval to Edwards Lifesciences' replacement heart valve, designed to treat mitral valve...

Cardiovascular Systems completes patients enrolment for orbital atherectomy system study
29 November 2012 Cardiovascular Systems has finished enrolling 443 patients in its first premarket approval (PMA) trial, designed to assess the safety and effectiveness of the electric orbital atherectomy...

SFDA approves Qiagen human papillomavirus diagnostic assay
29 November 2012 The China's State Food and Drug Administration (SFDA) has approved Qiagen's portable molecular diagnostic assay, designed for screening high risk human papillomavirus (HPV) in low-resource...

St Jude implants first patient with Portico heart valve using transapical approach
28 November 2012 Medical technology developer St Jude Medical has implanted the first patient with its Portico Transcatheter aortic heart valve using the Transapical delivery...

Tryton completes patient enrolment for Tryton Side Branch Stent study
28 November 2012 Tryton Medical has finished enrolling patients in the Tryton Pivotal IDE study, designed to compare the potential of Tryton's Side Branch Stent system with conventional balloon angioplasty...

Ansell launches non-latex antimicrobial surgical glove in Canada
27 November 2012 Surgical products developer Ansell has announced the availability of non-latex antimicrobial surgical glove in...

Merit Medical to buy Thomas Medical Products
27 November 2012 Disposable medical devices manufacturer Merit Medical Systems has signed a stock purchase agreement to buy GE Healthcare's US division, Thomas Medical Products, for $167m in...

Sphere Medical intravenous anaesthetic measuring device meets primary endpoint
26 November 2012 Sphere Medical's intravenous anaesthetic propofol measuring device has met the primary endpoint and demonstrated equivalent performance to a standard method for propofol analysis....

Volcano to purchase Sync-Rx
26 November 2012 US-based Volcano, a manufacturer of precision-guided therapy tools, has signed a definitive agreement to purchase Israeli software company Sync-Rx for an undisclosed...

Avita commences ReCell Spray-On Skin device trial in Europe
23 November 2012 Regenerative medicine company Avita Medical has commenced a clinical study in Europe to evaluate the potential of its ReCell Spray-On Skin device in treating venous leg...

FDA issues approvable letter to Dune Medical PMA for breast cancer detection system
23 November 2012 The US Food and Drug Administration (FDA) has issued an approvable letter for Dune Medical Devices' premarket approval application (PMA) for its MarginProbe breast cancer detection...

FDA approves HeartWare miniaturised ventricular assist system
22 November 2012 The US Food and Drug Administration (FDA) has approved HeartWare International's miniaturised ventricular assist system, designed as a bridge to cardiac transplantation in patients who are at...

FDA grants unconditional approval to Sunshine heart assist device study
22 November 2012 The US Food and Drug Administration (FDA) has granted unconditional approval to Sunshine Heart to initiate a clinical study on its implantable non-blood contacting heart assist device, designed...

St Jude wins CE mark for Portico transcatheter aortic heart valve
21 November 2012 The European Union has given CE mark approval to St Jude Medical's Portico Transcatheter aortic heart valve, designed to treat patients with severe aortic stenosis who are inoperable or...

Boston Scientific wins CE mark for increased longevity of ICDs and CRT-Ds
21 November 2012 The European Union has granted CE mark approval for the extended longevity provided by Boston Scientific's Incepta, Energen, Punctua, Cognis and Teligen implantable cardioverter...

Life Technologies introduces molecular diagnostic instrument in Europe
20 November 2012 Biotechnology company Life Technologies has introduced a new real-time PCR-based molecular diagnostic instrument for diagnostic...

Ventus launches obstructive sleep apnoea treatment in Canada
20 November 2012 Ventus Medical has announced the availability of a non-invasive treatment for mild, moderate and severe obstructive sleep apnoea (OSA) in Ontario,...

Medtronic treats first US patient using CoreValve system
19 November 2012 Medtronic has treated the first US patient in a global, multicentre clinical trial of its CoreValve system, which is designed to treat patients with severe aortic stenosis who are at...

FDA clears Cook Medical stent to treat peripheral artery blockages
19 November 2012 The US Food and Drug Administration (FDA) has approved Cook Medical's drug-eluting stent for treating peripheral arterial disease (PAD) in the superficial femoral...

Exact Sciences completes patient enrollment for stool DNA colorectal cancer screening study
16 November 2012 Molecular diagnostics company Exact Sciences has completed enrolling patients in its DeeP-C pivotal trial, designed to compare the accuracy of stool DNA testing with traditional screening...

IVUS-guided stent placement reduces stent thrombosis and MI in study
16 November 2012 Volcano Corporation has announced positive study results that demonstrate stent procedures guided by intravascular ultrasound (IVUS) reduce stent thrombosis and myocardial infarction (MI),...

FDA clears Medtronic tubular stent graft for aortic transection repair
15 November 2012 The US Food and Drug Administration (FDA) has cleared the expanded use of Medtronic's tubular stent graft for the endovascular repair of isolated lesions (excluding dissections) of the...

Enzo Biochem introduces new lung cancer diagnostic test in US
15 November 2012 Enzo Biochem's Clinical Labs has announced the availability of a new diagnostic test, designed to assess and detect lung cancer at earlier stages, in New York metropolitan market as well as...

CellAegis to begin noninvasive autoRIC device pilot trial in Canada
14 November 2012 Health Canada has granted investigational testing approval (ITA) to CellAegis Devices to initiate a pilot clinical trial of its noninvasive autoRIC device for remote ischemic conditioning...

Cambridge Consultants develops new auto-injector to ease IVF experience
14 November 2012 Innovative product development firm Cambridge Consultants has developed a new auto-injector to deliver viscous progesterone in oil (PiO) hormonal injections in women undergoing in...

Abiomed wins FDA IDE for percutaneous heart pump study
13 November 2012 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to Abiomed to initiate a pivotal clinical study of its percutaneous heart...

Kinetic Concepts introduces new negative pressure wound therapy in Canada
13 November 2012 Medical technology company Kinetic Concepts has launched its V.A.C.Ulta negative pressure wound therapy (NPWT) system in...

GE Healthcare acquires ultrasound breast screening products manufacturer
12 November 2012 GE Healthcare has acquired U-Systems, a manufacturer of ultrasound products for breast applications, for an undisclosed...

Boston Scientific to purchase renal denervation system developer Vessix Vascular
12 November 2012 Medical device manufacturer Boston Scientific has entered into a definitive agreement to purchase all the assets of Vessix Vascular for an upfront payment of...

Veredus introduces Lab-on-Chip device to detect multi-drug-resistant mycobacterium
09 November 2012 Veredus Laboratories, a Singapore-based subsidiary of STMicroelectronics, has introduced a multiplexed molecular diagnostic device for detecting mycobacterium tuberculosis complex (MTBC) and...

FDA approves Cordis vascular stent systems for use in SFA
09 November 2012 The US Food and Drug Administration (FDA) has approved Cordis' S.M.A.R.T. vascular stent systems for use in the superficial femoral artery (SFA) and/or the proximal popliteal...

Global urology devices market to reach $8.6bn by 2022: study
08 November 2012 The global market for urology devices will reach $8.6bn by 2022, according to Visiongain, a London-based business information...

EnteroMedics presents vagal blocking therapy subgroup analysis data
08 November 2012 EnteroMedics has presented hypertension data from its trial of VBLOC vagal blocking therapy for the treatment of obesity, delivered via the Maestro...

St Jude presents positive renal denervation device six month study data
07 November 2012 St Jude Medical has announced positive results from a six month clinical study of its multi-electrode renal denervation technology, designed to treat patients with drug-resistant...

BioCardia announces positive results from catheter-delivered MSCs Phase I/II trial
07 November 2012 BioCardia has reported positive results from a Phase I/II trial of allogenic and autologous adult mesenchymal stem cells (MSCs) delivered using its Helical Infusion System for the treatment...

BD, Diagenode announce European launch of Respiratory FLU A/B assay
06 November 2012 BD Diagnostics and Diagenode, a developer of infectious disease diagnostic products, have introduced Diagenode Respiratory FLU A/B assay in...

UK funds OJ-Bio to further develop flu diagnosis device
06 November 2012 The UK government-backed Biomedical Catalyst has awarded funding to support OJ-Bio's £1m project for the further development of its hand-held flu diagnosis...

SRS purchases AbbeyMoor Medical temporary prostatic stent
05 November 2012 SRS Medical, a manufacturer of voiding dysfunction diagnostic products, has purchased AbbeyMoor Medical's Spanner temporary prostatic stent for an undisclosed...

FDA clears new Accuray CyberKnife M6 series
05 November 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to Accuray's new CyberKnife M6 FIM and FM systems, designed for treating large and complex...

Biotronik Gold-tip ablation catheter found to create lesions faster
02 November 2012 Biotronik's GOLDEN TIME study has demonstrated that its AlCath Gold ablation catheter creates lesions 33% faster and delivers greater energy with a lower tip...

FDA clears Thermedical radiofrequency-based ablation system
02 November 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Thermedical's radiofrequency-based ablation system, designed to treat large volumes of solid...

St Jude FFR-based technology found to improve health outcomes, reduce costs in study
01 November 2012 St Jude Medical has announced that an analysis of the benefits of Fractional Flow Reserve (FFR)-guided intervention has found to improve health outcomes while saving...

Boston Scientific wins CE mark for bioabsorbable coronary stent
01 November 2012 The European Union has granted CE mark certification to Boston Scientific's coronary stent system with bioabsorbable technology, designed to improve post-implant vessel...

October 2012

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Smiths Medical wins CE mark for passive safety IV catheter
31 October 2012 The European Union has granted CE mark certification to Smiths Medical's passive safety device, designed to help protect clinicians and healthcare workers from unintended...

GI Dynamics to initiate non-surgical EndoBarrier liner pivotal trial for type 2 diabetes
31 October 2012 The US Food and Drug Administration (FDA) has granted full approval to GI Dynamics to initiate its ENDO trial, designed to assess the safety and efficacy of EndoBarrier liner in treating...

Maquet wins FDA, CE mark approvals for new size of intra-aortic balloon catheter
30 October 2012 Maquet Cardiovascular has obtained the US Food and Drug Administration (FDA) approval and CE mark certification for a new size of intra-aortic balloon (IAB) catheter, designed for patients...

US Senate Finance reports Medtronic role in shaping articles on bone-graft device
30 October 2012 The US Senate Finance Committee has reported findings of a 16-month investigation on Medtronic's bone-graft product, InFuse, designed for use in lower spine...

SenoSENSE completes enrolment in Electrical Breast Densitometer system study
29 October 2012 SenoSENSE Medical Systems, a medical device company, has completed enrolment in a 100-patient study of its Electrical Breast Densitometer system to measure breast...

FDA clears NuVasive cervical motion preserving device
29 October 2012 The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to NuVasive's cervical motion preserving device, designed for use in skeletally mature patients for reconstruction...

BioVentrix introduces minimally invasive myocardial anchoring system
26 October 2012 BioVentrix has launched a myocardial anchoring system for patients with ischemic...

C8 MediSensors continuous glucose monitor wins CE Mark
26 October 2012 C8 MediSensors has won CE Mark approval for its Optical Glucose Monitor System, a new non-invasive continuous glucose monitor (nCGM) for people with type 1 diabetes in...

CardioKinetix wins CE mark for new ventricular partitioning device sizing options
25 October 2012 The European Union (EU) has granted CE mark approval to CardioKinetix for the full size matrix of its percutaneous ventricular restoration device, designed to treat patients with ischemic...

Allegro reports lung cancer detection assay positive results
25 October 2012 Allegro Diagnostics, a molecular diagnostic company, has reported positive results from its airway epithelium gene expression in the diagnosis of lung cancer (AEGIS I) trial, designed...

Micro Interventional treats first patient in transapical access device trial
24 October 2012 Micro Interventional Devices has treated the first patient in sutureless transapical access and closure study (STASIS) using its transapical access device, designed to provide hemostatic access...

STENTYS wins FDA investigational device exemption to commence Self-Apposing stent study
23 October 2012 The US Food and Drug Administration has granted investigational device exemption (IDE) to STENTYS to initiate a pivotal clinical study of its Self-Apposing stent, for the treatment of de...

Nicox announces US launch of acute conjunctivitis diagnostic assay
23 October 2012 Nicox, a licensing partner of Rapid Pathogen Screening, has introduced a rapid point-of-care diagnostic test for acute conjunctivitis in the...

BD announces European launch of Trichomonas vaginalis detection assay
22 October 2012 The European Union has granted CE mark certification to BD Diagnostics' molecular detection assay, designed to diagnose Trichomonas vaginalis in women who are considered to be at high risk of...

Gore completes first patient enrolment in Septal Occluder study
22 October 2012 W. L. Gore & Associates has enrolled the first patient in its GORE Septal Occluder clinical study, designed to assess safety and efficacy of the delivery system in percutaneous,...

FDA approves Paradigm motion preserving interlaminar stabilisation device
19 October 2012 The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Paradigm Spine's motion preserving interlaminar stabilisation system, designed for treating moderate to...

Medtronic introduces new MR-conditional pacing system in Japan
19 October 2012 US-based medical technology provider Medtronic has announced the Japanese launch of a new MR-conditional pacing system, designed to provide pacemaker patients with access to full body scans...

AngioScore initiates patient enrolment in CardioSculpt catheter FIH study
18 October 2012 Endovascular company AngioScore has commenced patient enrolment of a first-in-human (FIH) study to evaluate its CardioSculpt Valvuloplasty Scoring Balloon catheter in patients with...

Digital security expert says medical device companies are failing to make pacemakers safe
18 October 2012 The poor programming of wireless bedside transmitters in pacemakers and implantable cardioverter-defibrillators (ICDs) could lead to deaths, according to new...

FDA clears Roche wireless hospital blood glucose monitor
17 October 2012 The US Food and Drug Administration (FDA) has cleared Roche's wireless hospital blood glucose monitoring system for managing...

AngioDynamics acquires endomechanical device developer Vortex Medical
17 October 2012 AngioDynamics, a provider of minimally invasive medical devices used in image-guided procedures, has acquired endomechanical device developer Vortex...

Uroplasty presents tibial nerve stimulator long-term study results
16 October 2012 Medical device company Uroplasty has presented positive results from a nine-year follow-up study of a subcutaneous tibial nerve stimulator for treating overactive bladder (OAB)...

Astute gets CE mark for acute kidney injury immunoassay test
16 October 2012 The European Union has granted Astute Medical CE mark certification for its risk assessment tool for patients who may develop acute kidney injury...

Biotronik introduces subcutaneous implantable cardiac monitor in Europe
15 October 2012 Biotronik has announced the European launch of a subcutaneous implantable leadless cardiac monitoring system for patients with atrial fibrillation (AF) or unexplained syncope, bradycardia,...

Cytori treats first US patient in ADRC therapy trial
15 October 2012 Cytori Therapeutics has treated the first US patient in its ATHENA trial using the company's cell therapy based on patient's own adipose-derived stem and regenerative cells...

Boston Scientific takes first patient in REPRISE II TAVR trial
12 October 2012 Boston Scientific has completed enrolling the first patient in its REPRISE II clinical trial, designed to assess safety and efficacy of the Lotus Valve system in minimising aortic...

FDA clears Respiratory Motion non-invasive bedside respiratory monitor
12 October 2012 The US Food and Drug Administration (FDA) has cleared Respiratory Motion's non-invasive respiratory monitor, designed for monitoring breathing abnormalities often associated with potentially...

Covidien reports DEFINITIVE LE study final results
11 October 2012 Covidien has reported final 12-month results of the Determination of Effectiveness of SilverHawk / TurboHawk Peripheral Plaque Excision Systems for the Treatment of Infrainguinal Vessels /...

Boston Scientific's Victory guidewire now available in the US and Europe
11 October 2012 Boston Scientific has announced the US and European launch of Victory guidewire, designed for crossing resistant...

GE Healthcare patient-worn monitors to feature Masimo oximetry cable
10 October 2012 GE Healthcare has selected Masimo's new uSpO2 universal pulse oximetry cable for use in its patient-worn monitors, designed for use in ambulatory patient care...

St Jude Medical launches real-time cardiac navigation technology
10 October 2012 St Jude Medical has launched a real-time cardiac navigation and visualisation technology that evaluates vascular and cardiac anatomy on a recorded fluoroscopic image instead of live...

Alere presents positive results of PlGF blood test
09 October 2012 Alere has reported positive results from a clinical trial of its placental growth factor (PlGF) blood test, designed for the diagnosis of pre-eclampsia in women suspected of it before 35...

Boston Scientific to purchase Rhythmia Medical
09 October 2012 Boston Scientific has entered into a definitive agreement to buy all the assets of US-based Rhythmia Medical, a developer of next-generation mapping and navigation...

Medtronic completes patient enrollment for IN.PACT DEEP trial
08 October 2012 Medtronic has completed enrolling patients in its IN.PACT DEEP trial, designed to demonstrate the safety and efficacy of Amphirion drug-eluting balloon in treating critical limb...

Crimson announces new advertising services to cope with French Decree
08 October 2012 Crimson Life Sciences, a division of TransPerfect Translations International, has announced new services to assist US medical device manufactures planning to respond to the French Decree...

Given Imaging purchases SmartPill non-imaging capsule
05 October 2012 Given Imaging has purchased SmartPill's single-use non-imaging capsule, designed for evaluating motility disorders such as gastroparesis and constipation, for...

Phenogen introduces non-invasive breast cancer risk assessment test
05 October 2012 Phenogen Sciences, a subsidiary of Genetic Technologies, has introduced a non-invasive genetic risk assessment test for women with a higher-than-average chance of developing...

US GAO urges FDA to address digital security risk of medical devices
04 October 2012 The US Government Accountability Office (GAO) has urged the Food and Drug Administration (FDA) to develop a plan to address information security risks for medical devices, including insulin...

Akonni wins NIH grant for nucleic acid isolation instrument development
04 October 2012 The US National Institutes of Health (NIH) has awarded a grant to Akonni Biosystems to develop a fully automated nucleic acid isolation instrument, which has the potential to...

EndoGastric completes patient enrolment in TEMPO trial
03 October 2012 EndoGastric Solutions has completed patient enrolment in its Transoral Incisionless Fundoplication (TIF) versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD symptoms...

Medtronic commences renal denervation therapy trial in Japan
03 October 2012 Medtronic has commenced a Japanese clinical trial of its minimally invasive renal denervation therapy to treat patients who are not responding to different types of anti-hypertensive...

FDA approves Globus articulating intervertebral disc replacement device
02 October 2012 The US Food and Drug (FDA) has granted premarket approval (PMA) to Globus Medical's articulating intervertebral disc replacement device, designed for patients with intractable symptomatic...

FDA grants conditional approval to Sunshine heart assist device
02 October 2012 The US Food and Drug Administration (FDA) has granted conditional approval to Sunshine Heart to conduct an investigational device exemption (IDE)) clinical study on its implantable heart...

Boston Scientific cardiac rhythm management device wins FDA approval
01 October 2012 Boston Scientific has received regulatory approval from the US Food and Drug Administration (FDA) for its cardiac rhythm management device, which is designed to treat patients at risk for...

NanoString awarded CE mark for breast cancer testing kit
01 October 2012 The European Union (EU) has granted a CE quality mark to NanoString Technologies' PAM50-based gene expression test for breast...

September 2012

Top

FDA clears MindChild non-invasive fetal heart monitor
28 September 2012 The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification application of MindChild Medical's non-invasive fetal heart...

EC proposes new regulations for safer medical devices
28 September 2012 The European Commission (EC) has proposed new medical device regulations in response the the PIP breast implant...

FDA clears Advanced Brain Monitoring neuro-cardio diagnostic tool
27 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to Advanced Brain Monitoring's neuro-cardio diagnostic tool to assess sleep architecture and...

Abbott announces global launch of bioresorbable vascular scaffold
27 September 2012 Abbott has introduced a bioresorbable vascular scaffold (BVS), designed to treat patients with coronary artery disease, in Europe, parts of Asia Pacific and Latin America....

Strand Diagnostics introduces new breast biopsy error detection kit
26 September 2012 Strand Diagnostics, an identity confirmation testing services provider, has introduced a new system to detect misidentification of breast biopsy...

FDA clears Precision spinal deformity correction system
26 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Precision Spine's correction system to treat acute and chronic instabilities or deformities of the thoracic, lumbar...

FDA clears Smiths neuraxial medication delivery system
25 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to Smiths Medical's neuraxial medication delivery system, designed to minimise the risk of tubing misconnections that...

Medtronic awarded CE mark for oxygenation system
25 September 2012 The European Union has granted CE mark approval to the Medtronic-developed oxygenator, which is designed to oxygenate and remove carbon dioxide from blood during open-heart surgical...

FDA clears Intelomed new real-time blood volume measuring device
24 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Intelomed's real-time blood volume measuring device, designed for patients with declining cardiovascular...

Medtronic completes first patient enrolment in Improve Brady study
24 September 2012 Medtronic has completed enroling first patient in its Improve Brady study, designed to provide evidence-based guidelines and recommended therapies for patients with sinus node...

St Jude wins CE mark for new mini rechargeable neurostimulator
21 September 2012 The European Union has granted CE mark approval to a mini rechargeable neurostimulator, developed by St Jude Medical to relieve pain and disability associated with intractable chronic...

Given Imaging seeks Japan's approval for PillCam Colon 2 video capsule
21 September 2012 Given Imaging, a developer of GI medical devices, has submitted an application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval to use its PillCam Colon 2 video...

Dfine introduces minimally invasive spine ablation system in US
20 September 2012 Dfine, a radiofrequency-based medical device manufacturer, has introduced its small steerable Star tumor ablation system in the US, which is designed for the palliative treatment of...

Boston Scientific to buy BridgePoint Medical
20 September 2012 Boston Scientific has entered into a definitive agreement to purchase all the assets of BridgePoint Medical, the developer of a catheter-based system for treating coronary chronic total...

FDA clears Aptus thoracic-length aortic aneurysm repair device
19 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Aptus Endosystems' thoracic-length HeliFX aortic securement system, designed for treating thoracic aortic aneurysms...

Hemerus new red blood cell storage system wins CE mark
19 September 2012 Hemerus Medical has announced CE mark approval of its new SOLX red blood cell additive (AS-7), designed to reduce storage lesions and improve the quality of red blood...

Roche announces US launch of new cytomegalovirus viral load test
18 September 2012 Roche has introduced a new real-time polymerase chain reaction-based cytomegalovirus (CMV) test in the US, for use on the company's COBAS AmpliPrep/COBAS TaqMan system to quantify the DNA of...

Auxogyn introduces non-invasive early embryo viability assessment test
18 September 2012 Auxogyn has announced the European Union launch of its non-invasive early embryo viability assessment (Eeva) test, designed to improve in-vitro fertilisation...

Biotronik introduces new Pulsar-35 self-expanding stent system
17 September 2012 Biotronik has introduced a new Pulsar-35 self-expanding stent system, designed to reduce target lesion revascularisation in superficial femoral artery...

ConvaTec new hydrofibre technology dressing now available in US
17 September 2012 ConvaTec, a medical technology company, has announced the US release of its Aquacel Ag Extra wound dressing with Hydrofiber technology for at-risk and infected...

Tangent NovaCath Secure IV Catheter System wins FDA approval
14 September 2012 Tangent Medical has received FDA 510(k) clearance for the NovaCath Secure IV Catheter...

FDA approves AtriCureAblate post-approval study
14 September 2012 The US Food and Drug Administration (FDA) has approved AtriCure's three-year Ablate post approval study (PAS), designed for the surgical correction of atrial...

FDA clears expanded indication of Covidien LigaSure small jaw surgical instrument
13 September 2012 Covidien has announced FDA 510(k) clearance of its LigaSure small jaw surgical instrument for use in head and neck...

Welch Allyn to cut ten percent of workforce in response to US medical device tax
13 September 2012 Welch Allyn, a diagnostic equipment manufacturer, has announced plans to cut 10% of its workforce in response to the upcoming US medical device...

Global hearing aid devices market set to grow to $11.3bn by 2018
12 September 2012 GBI Research, a provider of business intelligence reports, has reported that the global hearing aid market is estimated to grow to $11.3bn by 2018, at a compound annual growth rate of...

Spinal USA gains FDA clearance for solo anterior cervical plate system
12 September 2012 Spinal USA, a wholly owned subsidiary of Precision Spine, has gained 510(k) clearance from the FDA for the Slimplicity Solo anterior cervical plate...

ENTrigue, fiagon to explore navigation, therapy solutions for ENT procedures
11 September 2012 ENTrigue Surgical has entered into a collaboration agreement with a developer of portable navigation systems,...

FDA clears Abiomed Impella percutaneous heart pump
11 September 2012 US-based Abiomed has received 510(k) clearance from the US FDA for its Impella percutaneous heart pump, which provides peak flows of approximately four litres of blood per...

ApniCure reports additional positive results from ATLAST trial
10 September 2012 ApniCure has reported additional positive results from the ATLAST trial of its Winx sleep therapy system, designed to treat patients with obstructive sleep apnea...

AngioDynamics new peripherally inserted central catheter wins FDA nod
10 September 2012 Interface Biologics has announced that its licensing partner, AngioDynamics, has obtained US Food and Drug Administration (FDA) clearance for use of BioFlo peripherally inserted central...

NeuroSigma new neuromodulation system wins CE mark
07 September 2012 NeuroSigma has obtained CE mark approval for its external Trigeminal Nerve Stimulation (eTNS) system, Monarch, designed for the treatment of epilepsy and major depressive disorder in adults...

SinuSys wins CE mark for new sinus dilation system
07 September 2012 SinuSys has received CE mark approval for its low pressure, self-expanding AerOs Sinus Dilation system, designed to open the maxillary ostia and treat painful chronic...

CircuLite wins CE mark for new micro-blood pump system
06 September 2012 CircuLite has obtained CE mark approval for its new micro-blood pump, Synergy circulatory support system, designed to treat ambulatory heart failure...

AFCell reports positive results of amnion-based wound covering
06 September 2012 AFCell Medical has reported positive results from a clinical study of its amnion-based allograft membrane, AmnioClear wound covering, designed for reducing post-operative adhesions and pain...

LDR receives FDA approval for new lateral lumbar fusion system
05 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to LDR's Avenue L lateral lumbar cage system, designed for lateral lumbar...

FDA clears OptiMedica new Catalys Precision Laser system
05 September 2012 The US Food and Drug Administration (FDA) has granted 510(k) approval to OptiMedica's new Catalys Precision Laser system, designed for creating single-plane and multi-plane arc cuts and...

Diopsys develops new electroretinography vision test
04 September 2012 Medical instrumentation company, Diopsys, has developed an office-based NOVA-Pattern electroretinography (PERG) vision test for use in hospitals and research facilities by optometrists...

ImThera reports positive results of aura6000 THN sleep therapy system
04 September 2012 ImThera Medical has reported positive results from a clinical study of its aura6000 targeted hypoglossal neurostimulation (THN) sleep therapy system, designed for the treatment of obstructive...

Vascular Insights initiates ClariVein system dose-finding study
03 September 2012 Vascular Insights, a manufacturer of minimally invasive peripheral vascular devices, has initiated a multi-centre dose-finding study of its non-thermal vein ablation ClariVein system, designed...

Quest Diagnostics introduces new cervical cancer detection test
03 September 2012 Diagnostic testing services provider, Quest Diagnostics, has introduced a new cervical cancer test to evaluate women whose Papanicolaou (Pap) and human papillomavirus (HPV) tests show...

August 2012

Top

Sunshine seeks investigational device exemption to commence C-Pulse system pivotal trial
31 August 2012 American medical device developer, Sunshine Heart, has submitted its C-Pulse Heart Assist system's investigational device exemption (IDE) application to the US Food and Drug Administration...

Medgenics to initiate subcutaneous autologous tissue implant Phase I/II trials
31 August 2012 Israel's Ministry of Health has granted biopharmaceutical company Medgenics approval to initiate two Phase I/II clinical trials of subcutaneous autologous tissue implant, Infradure, in...

FDA clears AngioDynamics BioFlo peripherally inserted central catheters
30 August 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics' BioFlo peripherally inserted central catheters (PICCs), designed to reduce the accumulation...

Elixir gains CE mark for DESyne BD novolimus eluting coronary stent system
30 August 2012 Elixir Medical, a medical device company, has gained Conformité Européenne (CE) mark approval for the DESyne BD novolimus eluting coronary stent system to treat coronary artery...

FDA clears Covidien iDrive Ultra powered stapling system
29 August 2012 Covidien, a healthcare products company, has gained 510(k) clearance from the US FDA for the iDrive Ultra powered stapling...

CardioKinetix reports positive data of Parachute device
29 August 2012 CardioKinetix has reported positive three-year clinical data of its minimally invasive Parachute ventricular partitioning device, designed to treat patients with heart failure caused by damage...

Maquet reports positive data from IABC therapy trial
28 August 2012 Maquet Cardiovascular, a subsidiary of Swedish Getinge Group, has reported positive results from the IABP-SHOCK II trial of its intra-aortic balloon counterpulsation (IABC) therapy, designed...

Pulmonx to commence US study of emphysema therapy
28 August 2012 The US Food and Drug Administration (FDA) has given pulmonary medical device manufacturers Pulmonx permission to initiate an investigational device exemption (IDE) pivotal clinical study for...

FDA grants conditional approval to GI Dynamics EndoBarrier liner
27 August 2012 The US Food and Drug Administration (FDA) has granted a conditional approval to initiate a pivotal clinical trial of GI Dynamics' non-surgical EndoBarrier...

Tornier to purchase OrthoHelix Surgical Designs
27 August 2012 Tornier, a provider of surgical solutions, has entered into a definitive agreement to purchase all the assets of OrthoHelix Surgical Designs for...

Penumbra introduces new Reperfusion catheter for clot removal
24 August 2012 Penumbra has introduced their 5MAX Reperfusion catheter, designed to remove clots in patients with acute ischemic...

Alphatec introduces minimally invasive device for spinal surgeries
24 August 2012 Alphatec Holdings has introduced their minimally invasive BridgePoint spinous process fixation system, designed to immobilise and stabilise spinal segments without the need for pedicle screw...

Transgenomic receives NIH STTR grant for pancreatic cancer test development
23 August 2012 National Institutes of Health's (NHI) National Center For Advancing Translational Sciences has awarded a $100,000 small business technology transfer programme (STTR) Phase I grant to...

FDA clears Toshiba America Medical Vantage Titan 1.5T series
23 August 2012 The US FDA has cleared Toshiba America Medical Systems' new Vantage Titan 1.5T series, which features the 8, 16 and 32-channel MR systems....

FDA clears Sotera ViSi mobile patient monitoring system
22 August 2012 Sotera Wireless, a medical device company based in San Diego, California, has gained 510(k) FDA clearance for its wireless ViSi mobile patient monitoring...

Abbott receives CE Mark for everolimus eluting coronary stent system
22 August 2012 Abbott, a healthcare company, has received the CE Mark in Europe for their Xience Xpedition everolimus eluting coronary stent system to treat coronary artery disease and is launching the product...

Medtronic Viva/Brava cardiac resynchronisation therapy devices win CE mark
21 August 2012 Medtronic, a medical technology company, has won CE mark approval for its Viva/Brava cardiac resynchronisation therapy...

Vascular Solutions purchases Venture wire control catheter from St. Jude
21 August 2012 Vascular Solutions, a medical device company, has purchased the Venture wire control catheter from St. Jude Medical for...

EndoStim wins CE mark for LES Stimulation system
20 August 2012 EndoStim has obtained CE mark approval for its LES stimulation system, designed to treat gastro-esophageal reflux disease (GERD) and eliminate the need for daily proton pump inhibitor...

NICE releases positive diagnostics guidance on DySIS cervical cancer screening product
20 August 2012 The National Institute for Health and Clinical Excellence (NICE), part of the UK's National Health Service (NHS), has published positive diagnostics guidance on DySIS Medical's cervical...

Neusoft Positron wins CE Mark for Attrius PET systems
20 August 2012 Neusoft Positron Medical Systems has won CE mark approval and International Organization for Standardization (ISO) certification for their Attrius Positron Emission Tomography (PET)...

Alfa Wassermann introduces ACE Axcel Clinical Chemistry system
17 August 2012 Alfa Wassermann Diagnostic Technologies has introduced the new self-contained ACE Axcel clinical chemistry system, designed for use in physician office laboratories to process up to 285 tests...

Med fusion to validate Theranostics Health TheraLink assays
17 August 2012 Laboratory reference testing and clinical trial services company, med fusion, has entered into a market development agreement to validate the clinical utility of Theranostics Health's...

SIRS-Lab completes patient enrolment for VYOO pathogen test trial
16 August 2012 Molecular diagnostics company, SIRS-Lab, has finished enrolling patients in a clinical study of its VYOO molecular diagnostic test, designed to detect the presence of pathogens' genetic...

Antigen Discovery wins SBIR grant for microfluidic POC device development
16 August 2012 The National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health has awarded a Phase I small business innovation research (SBIR) grant of $600,000...

Biotronik implants first US patient with Lumax 740 dual-chamber ICD
15 August 2012 Biotronik has reported that the first US patient has been implanted with its Lumax 740 dual-chamber implantable cardioverter defibrillator...

Teleflex to purchase LMA International
15 August 2012 Teleflex Incorporated has entered into a definitive agreement to acquire all the assets of LMA International for S$343.5m ($276m) in...

FDA clears Stryker new Trevo Pro Retriever
14 August 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker Neurovascular's new clot removal technology, Trevo Pro...

USAISR completes clinical study of OxyBand wound dressing
14 August 2012 The United States Army Institute of Surgical Research (USAISR) has completed a clinical trial of OxyBand Technologies' OxyBand wound dressing, designed to deliver therapeutic pure oxygen to...

Cytori expands Celution system CE mark for new indication
13 August 2012 Cytori Therapeutics has expanded the Celution system's CE mark approval to include new indications including cryptoglandular fistula, caused by perianal infection, abnormal fecal contamination...

Sapheon reports VenaSeal system one year follow-up data
13 August 2012 Sapheon has reported one year follow-up data from a clinical study of its VenaSeal Sapheon closure system, designed to treat saphenous vein...

FDA clears GeNO inhaled nitric oxide delivery system
10 August 2012 The US Food and Drug Administration (FDA) has cleared GeNO's inhaled nitric oxide (NO) delivery system, GeNOsyl MV-1000, designed to treat pulmonary...

FDA clears Ethicon Endo-Surgery's Harmonic Ace+ shears
10 August 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ethicon Endo-Surgery's new Harmonic Ace+ shears with adaptive tissue technology, designed for use during...

Perpetuum develops new implantable self-energising pacemaker
09 August 2012 Perpetuum, a member of UK-based Nanotechnology Knowledge Transfer Network (NanoKTN), has developed a new implantable self-energising pacemaker. Designed to generate energy from human power,...

Cohera completes patient enrolment in TissuGlu surgical adhesive trial
09 August 2012 Cohera Medical has completed patient enrolment for a US clinical study of its internal TissuGlu surgical adhesive, designed to help eliminate fluid accumulation and the need for post...

FDA clears Abbott Omnilink Elite Vascular Stent system
08 August 2012 The US Food and Drug Administration (FDA) has cleared Abbott's Omnilink Elite vascular balloon-expandable stent system, which is designed as a treatment for atherosclerotic iliac artery...

Celsion, Philips to initiate ThermoDox, MR-Guided HIFU Phase II study
08 August 2012 The US Food and Drug Administration (FDA) has granted clearance to Celsion and Royal Philips Electronics to commence a Phase II study of ThermoDox combined with Sonalleve MR-guided high...

FDA clears Bausch + Lomb, Technolas Victus Femtosecond Laser
07 August 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Bausch + Lomb and Technolas Perfect Vision's Victus Femtosecond Laser platform for use during cataract and corneal...

FDA grants conditional approval to Sunshine C-Pulse system driver
07 August 2012 The US Food and Drug Administration (FDA) has granted conditional approval to Sunshine Heart's new C-Pulse system driver, designed to provide moderate to severe heart failure patients with...

Stratasys releases 3D printing WREX device case study
06 August 2012 Additive manufacturing machines maker, Stratasys, has released a case study of its 3D printing Wilmington Robotic Exoskeleton (WREX), designed as a treatment for arthrogryposis...

UK funds Endomagnetics to explore melanoma cancer detection
06 August 2012 Endomagnetics has received UK Government funding to explore the clinical feasibility of applying its magnetic sentinel lymph node (SLN) technology for detecting melanoma...

Conventus completes enrolment in Conventus DRS Implant trial
03 August 2012 Conventus Orthopaedic has completed patient enrolment in a clinical study of its Conventus DRS Implant, designed as a treatment for common distal radius...

Echo reports positive data from Symphony tCGM system trial
03 August 2012 Echo Therapeutics has reported positive results from a clinical study of its Symphony tCGM system, designed as a non-invasive, wireless, transdermal continuous glucose monitoring...

NICE releases DySIS cervical cancer screening product guidance
02 August 2012 National Institute for Health and Clinical Excellence (NICE), a special health authority of the National Health Service (NHS), has published positive diagnostics guidance on DySIS...

SciBase reports positive data from Nevisense device trial
02 August 2012 SciBase has reported positive results from the pivotal SIMPS study of its non-invasive point-of-care Nevisense device, designed for the detection of malignant...

Benvenue completes patient enrolment in KAST study
01 August 2012 Benvenue Medical has completed the enrolment of patients in its Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial (KAST), designed to compare the system...

French Government to support PneumRx RePneu LVRC study
01 August 2012 France's Ministry of Health will fund €1.3m, under the soutien aux techniques innovantes couteuses (STIC) programme, to support PneumRx's RePneu lung volume reduction coil (LVRC)...

July 2012

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FDA clears Covidien Nellcor bedside SpO2 monitor
31 July 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system, designed to detect heart rate and oxygen saturation...

Transgenomic to provide genetic testing services for MCW
31 July 2012 Transgenomic, a provider of molecular technologies, has entered into a collaboration agreement to provide its next-generation genetic testing services, including the Nuclear Mitome test, to...

FDA clears Bracco MultiHance injection for MRA use
30 July 2012 The US Food and Drug Administration (FDA) has approved the use of Bracco Diagnostics' MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in magnetic resonance angiography (MRA), designed...

Corin wins Cormet device lawsuit in New York
30 July 2012 New York's state court, in the US, has ruled in favour of the UK medical-device manufacturer Corin by dismissing the lawsuit brought by plaintiff Robert...

Nfocus reports positive follow-up data of Luna implant
27 July 2012 Nfocus Neuromedical has reported positive one-year follow-up results from an ongoing clinical study of its Luna aneurysm embolisation system (AES), designed as a treatment for both pre...

Bard completes enrolment in LEVANT 2 IDE trial
27 July 2012 C. R. Bard's Lutonix technology centre has completed enroling patients in its pivotal investigational device exemption (IDE) LEVANT 2 trial, designed to evaluate the Lutonix drug coated...

Genalyte introduces Maverick ENA autoantibody assay kits
26 July 2012 Genalyte has introduced Maverick ENA 4 and ENA 6 assay kits, designed for use on the company's Maverick detection system to simultaneously screen several autoantibodies found in...

FDA clears Corindus robotic-assisted CorPath 200 system
26 July 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Corindus Vascular Robotics' CorPath 200 system, designed for use in percutaneous coronary intervention (PCI) procedures...

Allegro Diagnostics completes enrolment in AEGIS II trial
25 July 2012 Allegro Diagnostics has completed patient enrolment in the 1,320-patient Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer II (AEGIS II) trial, designed to evaluate the...

Sunshine Heart releases follow-up data of C-Pulse study
25 July 2012 Sunshine Heart has announced that the first patient has completed a two-year follow-up mark for the C-Pulse Heart Assist System in the North America feasibility...

Auxogyn early embryo viability assessment wins CE mark
24 July 2012 Auxogyn has won CE mark approval for its non-invasive early embryo viability assessment (Eeva) test, designed to improve in vitro fertilisation (IVF)...

Quick-Med wins Mexican patent for NIMBUS technology
24 July 2012 Quick-Med Technologies, a life sciences company, has gained a new patent for its NIMBUS technology from the patent office of Mexico (Instituto Mexicano de la Propiedad...

BG Medicine seeks FDA approval for Galectin-3 assay
23 July 2012 BG Medicine, a developer of cardiovascular diagnostics, has filed 510(k) premarket notification with the US Food and Drug Administration (FDA) for approval of its Architect Galectin-3...

Blockade Medical embolisation coil system wins CE mark
23 July 2012 Blockade Medical has won CE mark approval for its Barricade coil system, designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral...

IntelligentMDx wins CE mark for disease diagnostic test
20 July 2012 IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system to detect genital and oral...

Crux wins FDA approval for bi-directionally retrievable VCF
20 July 2012 The US Food and Drug Administration (FDA) has cleared Crux Biomedical's bi-directional retrieval inferior vena cava filter (VCF), designed to trap blood clots leading to fatal pulmonary...

Idaho begins blood culture identification panel clinical study
19 July 2012 Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has started clinical trial of its FilmArray blood culture identification (BCID)...

FDA approves Roche Accu-Chek Combo insulin pump
19 July 2012 The US Food and Drug Administration (FDA) has cleared Roche's Accu-Chek Combo system for insulin pump therapy as a treatment for...

Arterial reports positive data from bioresorbable stent trial
18 July 2012 Arterial Remodeling Technologies has reported positive results of its biodegradable stent from the first-in-human arterial remodelling transient dismantling vascular angioplasty (ARTDIVA)...

St Jude introduces Unify Quadra CRT-D in Japan
18 July 2012 St Jude Medical has introduced the Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) in Japan, as a treatment for heart...

Thermo Fisher to buy transplant diagnostics services provider
17 July 2012 Thermo Fisher Scientific has entered into a definitive agreement to purchase One Lambda, a provider of transplant diagnostics services, for $925m in...

Paragonix wins SBIR grant for cardiac transport system development
17 July 2012 The National Heart, Blood and Lung Institute has awarded a Phase I small business innovation research (SBIR) grant to Paragonix Technologies for the pre-clinical development of the Paragonix...

St Joseph Hospital enrols first patient in Medtronic trial
16 July 2012 St Joseph Hospital, a not-for-profit Catholic hospital, has enrolled its first patient for the SYMPLICITY HTN-3 trial, conducted by Medtronic, which designed to evaluate the...

Cohera initiates TissuGlu surgical adhesive trial in Germany
16 July 2012 Cohera Medical has initiated a no-drain clinical trial at two prominent surgery centres in Germany, designed to evaluate TissuGlu surgical adhesive as a treatment for reducing complications...

BD Medical to buy anti-needlestick devices developer
13 July 2012 Becton, Dickinson and Company (BD) has entered into a definitive agreement to purchase Safety Syringes, a developer of passive needle shields and guards for prefilled...

BioControl initiates CardioFit INOVATE-HF second phase study
13 July 2012 The US Food and Drug Administration (FDA) has granted approval to BioControl Medical to initiate the second phase of its increase of vagal tone in heart failure (INOVATE-HF) study, designed...

Terumo completes patient enrolment in OSPREY stent trial
12 July 2012 Terumo Interventional Systems has completed enrolment of patients in its occlusive / stenotic peripheral artery revascularization study (OSPREY), designed to assess the company's...

Rcadia reports hemodynamic assessment technology study results
12 July 2012 Rcadia Medical Imaging has reported positive study results of its proprietary technique, designed to assess hemodynamic significance of coronary lesions from coronary CT angiography (cCTA)...

OrSense introduces Glasswing haemoglobin measurement system
11 July 2012 OrSense, a developer of non-invasive monitoring systems, has introduced a new portable, wireless Glasswing haemoglobin (Hb) measurement system to monitor anaemic conditions, detect haemorrhages...

Cayenne Medical introduces new Quattro shoulder repair system
11 July 2012 Cayenne Medical, a sports medicine device company, has introduced the new Quattro Shoulder System for rotator cuff and labral...

Long Beach selects Toshiba perfusion imaging system to diagnose stroke patients
10 July 2012 Long Beach Memorial, a primary stroke care centre for MemorialCare Health System, has selected Toshiba's Aquilion ONE dynamic volume CT system for comprehensive diagnosis and treatment planning...

Cook Medical new colonic controlled-release stent wins FDA approval
10 July 2012 Cook Medical has received US Food and Drug Administration (FDA) approval for its new Evolution colonic controlled-release stent, designed to relieve large-bowel obstructions prior to...

FDA clears Roche new viral load test
09 July 2012 The US Food and Drug Administration (FDA) has granted premarket approval to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus (CMV) DNA in human...

FDA approves Qiagen new companion diagnostic assay
09 July 2012 The US Food and Drug Administration (FDA) has approved Qiagen's new molecular companion diagnostic product, the therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux...

3D spine tracking technology could benefit young tennis players
06 July 2012 Loughborough University's sports technology research group has partnered with Midlands-based Charnwood Dynamics and the Lawn Tennis Association (LTA) to use its 3D motion tracking hardware...

Miracor treats first STEMI patient in Prepare Ramses study
06 July 2012 Miracor Medical Systems has treated the first three ST segment elevation myocardial infarction (STEMI) patients, enrolled in the Prepare Ramses study, using its pressure-controlled...

Gore wins CE mark for new Excluder stent-graft sizing options
05 July 2012 US-based W. L. Gore & Associates has won CE mark approval for new diameter sizes of its Gore Excluder AAA Endoprosthesis endovascular stent-graft, designed to treat abdominal aortic aneurysm...

FDA clears OraSure in-home rapid HIV test kit
05 July 2012 The US Food and Drug Administration (FDA) has cleared OraSure Technologies' OraQuick in-home HIV test to help people learn whether or not they have been infected with the HIV...

FDA clears Syneron new aesthetic multi-platform device
04 July 2012 The US Food and Drug Administration (FDA) has cleared Syneron Medical's new elos Plus multi-platform...

EU consortium receives funds to develop bioartificial liver
04 July 2012 The European Union's (EU's) Seventh Framework Programme (FP7/ 2007-2013), under grant agreement number 304961, is providing €4.2m for the design and development of a biomimetic bioartificial...

Boston Scientific completes patient enrolment in Prevail study
03 July 2012 Boston Scientific has completed patient enrolment in its Prevail confirmatory study, designed to evaluate Watchman left atrial appendage (LAA) closure device as a treatment to reduce risk of...

ETView wins CE Mark for Viva-EB line of airway devices
03 July 2012 ETView Medical has won European pre-market clearance for the Viva-EB product family, designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures...

FSS gains CE mark for FlexStent Iliac Self Expanding Stent System
02 July 2012 Flexible Stenting Solutions (FSS), a developer of flexible peripheral arterial, venous, neurovascular and biliary stents, has gained CE mark approval for the FlexStent Iliac Self Expanding...

EndoGastric Solutions initiates TEMPO trial
02 July 2012 EndoGastric Solutions has initiated the TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO)...

June 2012

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AutoGenomics PGx testing system gains Health Canada approval
29 June 2012 Health Canada has granted medical device Class III approval to AutoGenomics' new automated microarray-based Infiniti pharmacogenomic (PGx) testing...

NLT Spine reports positive data from Prow Fusion device trial
29 June 2012 NLT Spine, a developer of minimally invasive spine surgical devices, has reported positive results from the clinical trial of its Prow Fusion lumbar interbody fusion delivery...

Antares announces positive data from VIBEX MTX device trial
28 June 2012 Antares Pharma has reported positive results from the human factors usability study of its VIBEX Methotrexate (MTX)...

FDA clears Nanosphere blood culture test for gram-positive bacteria
28 June 2012 Nanosphere, a molecular diagnostics products provider, has received a de novo petition from the US Food and Drug Administration (FDA) to market its gram-positive blood culture nucleic acid...

Tocagen to use MRI Interventions technology in brain cancer study
27 June 2012 Tocagen has formed strategic alliances with MRI Interventions and Brainlab to visualise local drug delivery in patients suffering from recurrent glioblastoma multiforme brain...

Seegene develops new HPV genotyping assay
26 June 2012 Molecular diagnostic technologies developer, Seegene, has developed a new genotyping assay, the QuantPlex HPV28 assay....

Teleflex purchases Semprus non-leaching polymer technology
26 June 2012 Speciality medical devices provider Teleflex Incorporated has purchased Semprus BioSciences' Sustain technology for an upfront payment of...

BD Biosciences introduces new FACSJazz cell sorter
25 June 2012 Medical technology company BD Biosciences has introduced its new FACSJazz flow cytometer cell...

Covidien introduces Nellcor SpO2 single parameter module
25 June 2012 Patient monitoring and respiratory care devices provider Covidien has introduced the Nellcor SpO2 single parameter module for use with Philips' IntelliVue MP40, MP90, MX 600, MX 700 and MX...

Cartiva completes patient enrolment in MOTION trial
22 June 2012 Orthopedic implants developer Cartiva has completed enrolling patients in its MOTION trial, designed to evaluate the Cartiva synthetic cartilage implant (SCI) as a treatment for reducing...

Zilico receives funding to develop new cervical cancer diagnostic device
22 June 2012 Zilico has received £750,000 in investment funding from the North West Fund for Biomedical and £235,000 from its new and existing investors, Fusion IP, to develop and manufacture a new...

Covidien introduces knotless suturing device for bariatric surgery
21 June 2012 Healthcare products company, Covidien, has introduced its new V-Loc knotless suture reload device, which is designed to increase operating room efficiency during single-incision bariatric...

Chembio presents positive data from HCV antibody assays
21 June 2012 Chembio Diagnostics has presented positive data from a study of three premarket, rapid hepatitis C virus (HCV) antibody...

MAQUET new antimicrobial vascular graft wins CE Mark
20 June 2012 Medical systems provider, MAQUET Cardiovascular, has obtained CE Mark approval for its new Intergard Synergy antimicrobial vascular...

University of Southampton, Roke develop new system for stroke patients
20 June 2012 The University of Southampton and Roke Manor Research, a Chemring company, are currently working on the use of Microsoft's Xbox Kinect system to help support stroke...

FDA clears St. Jude vascular plug for transcatheter embolisation procedures
19 June 2012 St. Jude Medical, a medical device company, has gained FDA clearance for the Amplatzer Vascular Plug 4 (AVP 4) for use in transcatheter embolisation procedures within the peripheral...

Seegene develops new QuantPlex RV-16 Assay for respiratory diseases
19 June 2012 South Korea-based Seegene has developed the QuantPlex RV-16 Assay for quantification of 21 respiratory viral pathogens associated with respiratory...

FDA clears Kinetic Concepts VAC therapy system for new indication
18 June 2012 Kinetic Concepts (KCI), a medical technology company, has won 510(k) FDA clearance for Vacuum Assisted Closure, or VAC therapy system, for the management of closed surgical...

UNITAID funds $30m to increase tuberculosis test access
18 June 2012 UNITAID, a global health initiative established by the governments of Brazil, Norway, Chile, France and the UK, has approved a fund worth $30m to reduce the cost of and increase access to...

Endosense completes patient enrolment in TOCCASTAR IDE study
15 June 2012 Switzerland-based Endosense has completed enrolment in the TOCCASTAR investigational device exemption (IDE) study of its TactiCath force-sensing ablation...

Continua approves TRaC Global as certified test laboratory
15 June 2012 TRaC Global, a UK-based testing, consultancy, certification and global approvals services provider for the communications industry, has received Continua Health Alliance approval as a...

FDA clears Siemens Somatom Perspective CT scanner
14 June 2012 Siemens Healthcare has received FDA clearance for its Somatom Perspective computed tomography (CT) scanner, designed to improve efficiency and reduce...

ConvaTec introduces Flexi-Seal Signal fecal management system in US
14 June 2012 ConvaTec, a developer of medical technologies, has launched the enhanced Flexi-Seal Signal fecal management system (FMS) in the...

Hospira upgrades TheraDoc clinical surveillance system
13 June 2012 Hospira, a provider of injectable drugs and infusion technologies, has introduced the enhanced TheraDoc clinical surveillance system, the TheraDoc system version 4.5, to help hospitals...

Endosense wins CE Mark for TactiCath Quartz force-sensing ablation catheter
13 June 2012 Geneva-based Endosense, a medical technology company, has won CE Mark approval for its TactiCath Quartz force-sensing ablation catheter for the treatment of atrial fibrillation and...

Aircraft Medical introduces disposable paediatric video laryngoscope
12 June 2012 UK-based Aircraft Medical has introduced the McGrath MAC 2 blade, a disposable paediatric video laryngoscope, compatible with the McGrath MAC video...

FDA clears MEVION S250 proton therapy system
12 June 2012 US-based Mevion Medical Systems has won FDA 510(k) clearance for its Mevion S250 proton therapy...

Nonin introduces cerebral/somatic sensor for neonatal, paediatric patients in US
11 June 2012 Nonin Medical, a manufacturer of non-invasive medical monitoring solutions, has launched the Equanox Advance Model 8004CB series neonatal / paediatric sensor in the...

FDA clears SomnoMed SomnoDent G2 technology
11 June 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for SomnoMed's SomnoDent G2...

CardioKinetix begins PARACHUTE III study of Parachute ventricular partitioning device
08 June 2012 CardioKinetix has commenced enrolment for a post-market safety surveillance trial, PARACHUTE III, of the Parachute ventricular partitioning device, in...

Neurotech wins CE Mark for neurostimulation device
08 June 2012 Belgium-based Neurotech has received CE Mark approval for its ADNS-300 system to treat refractory...

Medtronic introduces Endurant II AAA stent graft system in US
07 June 2012 Medtronic has introduced the Endurant II AAA stent graft system in the US, following approval from the Food and Drug Administration...

CeQur begins PaQ insulin delivery device study
07 June 2012 Switzerland-based CeQur has commenced a clinical study with the PaQ insulin delivery device for people with Type 2...

FDA clears Boston Scientific new lengths of Promus Element Plus stent system
06 June 2012 The US Food and Drug Administration (FDA) has cleared Boston Scientific's new 32mm and 38mm length Promus Element Plus everolimus-eluting platinum chromium coronary stent...

LabCorp to take over Medtox Scientific
06 June 2012 Laboratory Corporation of America Holdings (LabCorp) has signed an agreement to acquire Medtox Scientific for $27 a share in cash, representing a total enterprise value of approximately...

Covidien introduces Endo GIA Radial Reload
01 June 2012 Covidien, a manufacturer of medical and healthcare products, has introduced the Endo GIA Radial...

Menssana Research develops breath test to detect tuberculosis
01 June 2012 Menssana Research has developed a rapid point-of-care breath test in Newark, US, that accurately detects active pulmonary tuberculosis (TB), according to a report published in the...

May 2012

Top

European Commission clears Medtronic growth guidance system
31 May 2012 Medtronic has received a CE Mark for its Shilla growth guidance system designed to treat early-onset scoliosis (EOS), a curvature of the spine that can occur in the paediatric population before...

FDA clears Teleflex Arrow FlexTip Plus closed tip, multi-port catheter
31 May 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Teleflex's Arrow FlexTip Plus closed tip, multi-port epidural...

Maquet acquires Avalon Laboratories bi-caval dual lumen catheter
30 May 2012 Maquet Cardiopulmonary, a business unit of Maquet Cardiovascular, has executed an agreement to purchase Avalon Laboratories' Avalon Elite bi-caval dual lumen catheter and complimentary...

Nasa, ASU researchers develop new technique to diagnose early osteoporosis
30 May 2012 Nasa researchers, in collaboration with researchers from the Arizona State University (ASU), US, have developed a new way of detecting osteoporosis in the earliest disease...

European scientists develop new biosensor test to detect diseases earlier
29 May 2012 Researchers from Imperial College London and the University of Vigo, Spain, have developed an ultra-sensitive test to detect the signs of disease in its earliest...

Medtronic Resolute stent shows efficacy in two-year study
29 May 2012 Medtronic's Resolute drug-eluting stent (DES) has reported strong performance in coronary artery disease (CAD) patients, both with and without...

Stryker Trevo system found to improve post-device revascularisation
28 May 2012 Stryker's Trevo Retriever has met the primary effectiveness endpoint, achieving better post-device revascularisation compared to the Merci Retriever (86.4% in the Trevo Retriever arm compared...

European Commission clears TrueDX platform and TSH assay
28 May 2012 True Diagnostics has received CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in...

InspireMD concludes patient enrolment in MASTER trial
25 May 2012 InspireMD has completed patient enrolment in the MGuard for Acute ST Elevation Reperfusion (MASTER) trial, designed to evaluate MGuard and MGuard Prime coronary...

Smith & Nephew wound therapy system found to reduce healing time
25 May 2012 Smith & Nephew has announced the preliminary independent data demonstrating that patients using the Pico negative pressure wound therapy (NPWT) system had reduced healing times and increased...

Baxano concludes patient enrolment in iO-Flex system trial
24 May 2012 Baxano has concluded patient enrolment in its iO-Flex system study, designed to evaluate the efficacy of the device in decompressing patients with moderate to severe lumbar spinal stenosis,...

Biotronik presents positive six-month data of Pulsar stent
24 May 2012 Biotronik has reported positive data from the six-month 4EVER study which evaluated the efficacy and safety of the Pulsar stent system in 120 superficial femoral artery (SFA) patients....

ApniCure Winx device found effective against sleep apnea
23 May 2012 ApniCure's Winx sleep therapy system has reported improvements in apnea-hypopnea index (AHI), a common measurement of sleep apnea severity, oxygen desaturation index (ODI), and sleep...

Cambridge Cognition introduces dementia test for UK physicians
23 May 2012 Cambridge Cognition, a British developer of neuropsychological tests, has introduced its CANTABmobile device, designed to radically improve dementia care in the...

Boston reveals positive data from Platinum Small Vessel study
22 May 2012 Boston Scientific's 2.25mm Promus Element everolimus-eluting platinum chromium (PtCr) stent system has demonstrated safety and effectiveness in treating de novo coronary lesions in small...

Biotronik Pantera Lux balloon shows efficacy in DELUX registry
22 May 2012 Biotronik's Pantera Lux paclitaxel-releasing balloon has demonstrated safety and efficacy in treating restenotic coronary artery lesions after drug-eluting or bare metal stenting in the...

Boston Epic vascular stent now available in US
21 May 2012 The US Food and Drug Administration (FDA) has granted marketing approval for Boston Scientific's Epic vascular self-expanding stent...

CardioKinetix Parachute implant shows efficacy in two-year study
21 May 2012 CardioKinetix's Parachute ventricular partitioning device has demonstrated meaningful and sustained improvement in clinical outcomes in patients with ischemic heart failure, in a two-year...

UK health department, Wellcome Trust support new technologies for NHS patients
18 May 2012 The UK Department of Health and the Wellcome Trust are supporting the development of new gene therapies and medical devices to transform treatments on the NHS, through the Health...

Medtronic IN.PACT drug-eluting balloons show efficacy in treating narrowed arteries
18 May 2012 IN.PACT drug-eluting balloons from Medtronic have demonstrated benefits in the two multicentre, randomised controlled trials in treating patients with coronary and peripheral artery...

Biotronik reports positive data from BIOSOLVE-I trial
17 May 2012 Biotronik's drug eluting absorbable metal scaffold (DREAMS) demonstrated safety and confirmed vessel vasomotion in the 12-month multicentre BIOSOLVE-I...

PneumRx gain FDA approval to begin RePneu LVRC system pivotal trial
17 May 2012 PneumRx has received US Food and Drug Administration approval to initiate a 30-site pivotal clinical trial to support a premarket approval (PMA) application for the RePneu lung volume...

Maquet intra-aortic balloon catheters get FDA clearance
16 May 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Maquet Cardiovascular's new Mega 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB)...

SAMS seeks donated medical devices to save Syrian lives
16 May 2012 The Syrian American Medical Society (SAMS) will receive donated medical devices as part of its 'Save Syrian Lives' campaign in...

EC clears Boston Innova bare-metal stent system
15 May 2012 The European Commission (EC) has granted CE-mark approval for Boston Scientific's Innova self-expanding bare-metal stent system, which is designed to treat peripheral vascular lesions in...

Piramal Healthcare announces positive BST-CarGel implant study data
15 May 2012 Piramal Healthcare Bio-Orthopaedics, a division of Piramal Healthcare, has announced positive data from its pivotal Phase 3 clinical trial of...

Intel-GE Care Innovations' Guide proven effective in Italian pilot study
14 May 2012 Intel-GE Care Innovations' telehealth monitoring device, Guide, has been found effective in an Italian pilot study conducted at Istituto Mediterraneo per i Trapianti e Terapie ad...

Boston Scientific's Watchman LAAC device found to reduce stroke risk
14 May 2012 Boston Scientific's Watchman left atrial appendage closure (LAAC) device has reduced the risk of ischemic stroke by 75% in patients with atrial fibrillation who have a contraindication to...

FDA clears St. Jude Ellipse cardioverter defibrillator
11 May 2012 St. Jude Medical's Ellipse implantable cardioverter defibrillator (ICD) has gained US Food and Drug Administration (FDA) approval for treating lethal, abnormally fast heart rhythms that often...

European Commission approves Loma Vista True Dilatation balloon catheter
11 May 2012 Loma Vista Medical has received CE mark clearance for its True Dilatation balloon valvuloplasty catheter, indicated for preventing balloon ruptures in balloon aortic valvuloplasty (BAV)...

HeartWare concludes patient enrolment in Endurance therapy trial
10 May 2012 HeartWare International has completed patient enrolment in an Endurance pivotal destination therapy clinical study designed to evaluate the use of the HeartWare ventricular assist system...

Abbott releases FreeStyle glucose monitoring device in Canada
10 May 2012 Abbott's new FreeStyle InsuLinx blood glucose monitoring system designed for calculating suggested insulin doses is now available in diabetes centres and select pharmacies across...

St. Jude Assura defibrillators get FDA clearance
09 May 2012 The US Food and Drug Administration (FDA) has approved St. Jude Medical's Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy...

FDA clears Ventana p53 image analysis algorithm
09 May 2012 Ventana Medical Systems, a member of the Roche Group, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Companion Algorithm p53 (DO-7) image analysis...

Qiagen takes over AmniSure International
08 May 2012 Qiagen has acquired AmniSure International, the US-based medical device company responsible for the commercialisation of its AmniSure assay for determining whether a pregnant woman is...

Modern Mobility, Lumigene to develop molecular diagnostic products
08 May 2012 US-based Modern Mobility Aids has announced an agreement with Canada's ACGT to integrate its resources and expertise with LumiGene Technologies, to develop and commercialise molecular...

Boston Scientific cardiac pacemakers win FDA approval
08 May 2012 The US Food and Drug Administration (FDA) has granted Boston Scientific approval to market its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers...

Echo Therapeutics announces glucose monitoring system trial data
04 May 2012 Echo Therapeutics has reported positive results from the clinical trial of its Symphony transdermal continuous glucose monitoring (tCGM) system in elective cardiac surgery...

Advanced Brain Monitoring introduces oral sleep apnea device
04 May 2012 Advanced Brain Monitoring has launched Apnea Guard, the first validated temporary oral appliance with clinical equivalence to custom oral appliances for the treatment of snoring and sleep...

Edwards Lifesciences reports positive results from TRITON trial
03 May 2012 The European multicentre study conducted by Edwards Lifesciences has demonstrated the benefits of its Intuity valve system in facilitating small-incision surgery for aortic valve replacement...

Great Basin C. difficile diagnostic assay gets FDA approval
03 May 2012 The US Food and Drug Administration (FDA) has granted approval for Great Basin's molecular diagnostic test for Clostridium difficile (C....

Cohera treats first patient using TissuGlu surgical adhesive
02 May 2012 Cohera Medical announced that the first patient has been treated in a US prospective multicentre randomised clinical trial of its TissuGlu surgical...

FDA clears Nephros' hemodiafiltration system
02 May 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Nephros' hemodiafiltration (HDF) system, designed for the treatment of chronic kidney disease...

Hologic to take over Gen-Probe for $3.7bn
01 May 2012 Hologic, a developer of diagnostics products, medical imaging systems and surgical products, has signed a definitive agreement to acquire all outstanding shares of Gen-Probe for $82.75 per share...

Medtronic announces six month outcomes of Symplicity system
01 May 2012 Medtronic's Symplicity renal denervation system has shown sustained blood pressure reduction, with no evidence of renal impairment, at six months post treatment in patients with...

April 2012

Top

Biotronik introduces Evia HF-T pacemaker in Europe
30 April 2012 Biotronik has launched a new cardiac resynchronisation therapy (CRT-P) device, the Evia HF-T pacemaker, in the European...

Luminex wins CE mark for newborn screening platform
30 April 2012 Luminex has received CE mark approval for its newborn screening solutions, xMAP NeoPlex4 assay and NeoPlex...

FDA clears Galt VTI valved tearaway introducer
27 April 2012 Galt Medical, a wholly-owned subsidiary of Theragenics, has received US Food and Drug Administration 510(k) clearance to market its Galt VTI valved tearaway...

Lophius concludes study of T-Track CMV / EBV tests
27 April 2012 German-based developer of T-cell based diagnostic testing systems Lophius Biosciences has completed a prospective multicentre clinical validation study for its T-Track CMV / EBV...

JDRF joins with Dexcom to develop smart transmitter
26 April 2012 The Juvenile Diabetes Research Foundation (JDRF) has partnered with Dexcom, a medical device company focused on developing and marketing continuous glucose monitoring (CGM) systems, to...

Boston Emerge dilatation catheter gets European approval
26 April 2012 Boston Scientific has gained European marketing approval for its Emerge PTCA dilatation catheter designed for treating coronary artery...

Roche introduces sequencing assays against leukaemia
25 April 2012 Swiss-based Roche has introduced the GS GType TET2/CBL/KRAS and the GS GType RUNX1 Primer Sets for comprehensive genetic variation detection in leukaemia samples, using its 454 GS Junior and GS...

Boston concludes patient enrolment in Lotus valve system trial
25 April 2012 Boston Scientific completed patient enrolment for its Reprise I clinical trial designed to assess the acute safety of the Lotus aortic valve system, used to treat patients with severe aortic...

Miramar miraDry system reports efficacy in sweat reduction
24 April 2012 Miramar Labs has announced the 18 months of follow-up data from a study which evaluated the efficacy and safety of the miraDry system, a non-invasive technology designed to treat primary...

Natus Medical to buy CareFusion neurodiagnostic business
24 April 2012 CareFusion, a medical technology company, has signed an agreement with Natus Medical to divest its Nicolet business for a cash purchase price of around...

Sequana reports efficacy data from Pioneer study for ALFApump
23 April 2012 The Pioneer clinical study conducted by Sequana Medical demonstrated the safety and efficacy of its automated low-flow ascites pump (ALFApump) system for the management of ascites in patients...

Abbott's iFS laser system wins FDA nod for cataract surgery
23 April 2012 Abbott Medical Optics (AMO) has received US Food and Drug Administration (FDA) approval to use its iFS Advanced Femtosecond Laser system to produce bow-shaped or curved arcuate incisions in...

Brainsway reports positive Deep TMS system trial data
20 April 2012 Brainsway has announced positive results from its double-blind multicentre clinical trial of its deep transcranial magnetic stimulation (Deep TMS) system for treating major...

US clears Carestream mobile x-ray system
20 April 2012 The US Food and Drug Administration (FDA) cleared Carestream's DRX-Revolution mobile x-ray system which improves image quality, manoeuvrability and...

Artificial kidneys could reduce hospital re-admissions and costs
19 April 2012 Wearable Artificial Kidneys (WAKs) will minimise hospital re-admissions and medical expenditure related to hospitalisation and treatment for patients suffering from end stage renal disease...

Chembio completes patient enrolment for DPP HIV test trial
19 April 2012 Chembio Diagnostics has completed patient enrolment in a pivotal clinical trial of its dual path platform (DPP) human immunodeficiency virus (HIV) 1/2 assay, used for the detection of...

Medtronic Endurant stent shows positive results in US study
18 April 2012 Medtronic has announced the two-year results from its US clinical study of the Endurant AAA stent graft system, used to treat patients with abdominal aortic aneurysms (AAA) with a...

Isansys patient monitoring system wins CE mark approval
18 April 2012 UK-based Isansys Lifecare has received CE mark certification for what it claims is the world's first cloud-ready medical device, LifeTouch Patient Surveillance system, comprising the...

St. Jude Medical Ellipse ICD now available in Europe
17 April 2012 St. Jude Medical has gained European marketing approval for its Ellipse implantable cardioverter defibrillator (ICD), designed to treat potentially lethal, abnormally fast heart rhythms which...

Piramal reports positive Phase III results of PET imaging with florbetaben
17 April 2012 Piramal Imaging, a subsidiary of Piramal Healthcare, reported positive results from a Phase III study which indicated that PET imaging with florbetaben detects beta-amyloid in the brain, giving...

Seattle Genetics, Millennium, Ventana to develop diagnostic test for Adcetris
16 April 2012 Seattle Genetics, Millennium: The Takeda Oncology Company and Ventana Medical Systems have formed a collaboration to develop, manufacture and commercialise a molecular companion diagnostic test...

Medtronic treats first patients in US drug-eluting balloon study
16 April 2012 Medtronic has treated its first patients in its IN.PACT SFA II study, the company's first US clinical trial for its line of IN.PACT drug-eluting...

RiboMed (RCSL) introduces brain cancer prognostic assay
13 April 2012 RiboMed Clinical Services Laboratory (RCSL), a CLIA-certified subsidiary of RiboMed Biotechnologies, has launched a multimarker methylation prognostic test for grading gliomas, a common type...

OptiMedica wins CE mark for Catalys laser system
13 April 2012 The European Commission (EC) has granted CE mark approval for OptiMedica's Catalys precision laser system for creating single-plane and multiplane arc cuts / incisions in the cornea during...

Intact Vascular stapler device receives European approval
12 April 2012 The European Commission has granted CE mark approval and ISO Certification for Intact Vascular's Tack-it Endovascular Stapler device, used for treating peripheral artery disease...

Honeywell offers new touch screen tablet device
12 April 2012 Honeywell HomMed has revealed a new personal health device, Genesis Touch, designed to address the current and future needs of patients who use telehealth to manage their...

ReCor Medical announces updated data from REDUCE study
11 April 2012 ReCor Medical has announced updated data from the REDUCE first-in-man clinical study of its percutaneous renal denervation system (PARADISE), used for treating resistant hypertension, a major...

Boston Scientific pacemakers now available in Europe
11 April 2012 Boston Scientific has received CE mark approval to launch its Ingenio and Advantio pacemakers, along with Invive cardiac resynchronisation therapy pacemakers (CRT-P), in...

Japan clears Abbott's Xience Prime stent system
10 April 2012 Abbott has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Xience Prime everolimus eluting coronary stent system, designed for treating coronary...

Devon Medical extriCARE wound therapy device wins FDA nod
10 April 2012 The US Food & Drug Administration (FDA) has granted 510(k) clearance to market Devon Medical Products' extriCARE 2400 negative pressure wound therapy (NPWT)...

EnteroMedics Maestro RC system reports efficacy data
05 April 2012 EnteroMedics has published 2.5-year diabetes, hypertension and weight loss data from the company's DM2 Enable study of vagal blocking (VBLOC therapy) delivered via the Maestro Rechargeable...

Scripps scientists to develop new screening tests for HCV
05 April 2012 The National Institutes of Health (NIH), an agency of the US Department of Health and Human Services, has awarded a $1m grant to The Scripps Research Institute for a three-year study intended...

NICE issues positive draft guidance on DySIS colposcopy
04 April 2012 The National Institute for Health and Clinical Excellence (NICE), UK, has issued draft guidance on DySIS Medical's cervical cancer screening product for public...

Quidel C. difficile diagnosis assay wins CE mark
04 April 2012 Quidel, a provider of rapid diagnostic testing solutions and cell-based virology assays, received the CE mark for its Quidel Molecular Direct C. difficile Tox A/B assay for detection of...

Elekta gets approval to CE mark Agility device
03 April 2012 Elekta has received clearance to CE mark its Agility multileaf collimator (MLC), a beam-shaping device integrated into the head of a linear accelerator (linac) for treating...

German researchers develop remote power transmitter
03 April 2012 Researchers at the Fraunhofer Institute for Ceramic Technologies and Systems IKTS in Hermsdorf, Germany, have developed a portable transmitter module for wirelessly transmitting power to a...

Covidien introduces AccuMesh hernia repair system
02 April 2012 Covidien, a healthcare products company, has introduced the AccuMesh positioning system, a comprehensive, evidence-backed hernia repair...

Abbott receives CE mark for PLEX-ID identification system
02 April 2012 The European Commission has approved and granted the CE mark (Conformité Européene) to Abbott's PLEX-ID molecular system including three assays (PLEX-ID Viral IC Spectrum, PLEX-ID BAC Spectrum...

March 2012

Top

AlCath catheter with MVG technique delivers optimal results, say Biotronik
30 March 2012 Biotronik's AlCath Gold ablation catheter, together with the maximum voltage-guided (MVG) technique for radiofrequency catheter ablation of atrial flutter, has demonstrated improved...

Bristol-Myers joins Meso Scale to develop assays for brain disorder
30 March 2012 Bristol-Myers Squibb and Meso Scale Discovery have signed an agreement to develop diagnostic assays which measure cerebrospinal fluid biomarkers for use in Alzheimer's disease...

Tech company iSonea starts paediatric asthma trial of WheezoMeter
29 March 2012 Medical technology company iSonea has initiated a US post-market study of its WheezoMeter monitoring technology in paediatric patients with a range of asthma symptom...

DiaGenic, GE Healthcare to develop test for Alzheimer's
29 March 2012 DiaGenic has reached an agreement with GE Healthcare to develop a blood-based test using DiaGenic's peripheral gene expression profiling, in patients with mild cognitive impairment, a...

Study finds pharmacogenomic testing can improve adherence to statin therapy
28 March 2012 Medco Research Institute (MRI), a subsidiary of Medco Health Solutions and Quest Diagnostics, has announced the Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS) study...

Boston supports trial to evaluate coronary stents in AMI patients
28 March 2012 Boston Scientific announced its support for the Horizons II AMI clinical trial, designed to evaluate safety and efficacy of the Promus Element plus everolimus-eluting platinum chromium...

Medtronic pacemakers may help reduce fainting recurrence rates
27 March 2012 Medtronic has reported results from a double-blind randomised study which demonstrated that patients who suffered from fainting due to neurocardiogenic syncope had fewer occurrences when...

Medtronic Symplicity system reports blood pressure reduction
27 March 2012 Medtronic's Symplicity renal denervation system has demonstrated safe and sustained blood pressure reduction for up to three years in patients with treatment-resistant hypertension, according...

Boston commences US, international launch of WallFlex transhepatic stent
26 March 2012 Boston Scientific has initiated the US and international launch of its WallFlex biliary transhepatic stent system, along with a percutaneous delivery system, designed for use by...

Boston Promus Element shows superiority over Xience V stent
26 March 2012 Boston Scientific's Promus Element everolimus-eluting platinum chromium (PtCr) coronary stent system demonstrated superior safety and efficacy compared to the Promus (Xience V)...

Bioline illumigene GBS assay gets Australian clearance
23 March 2012 Bioline, a wholly-owned subsidiary of Meridian Bioscience, has received clearance from the Therapeutic Goods Administration (TGA) to commercialise its illumigene Group B Streptococcus (GBS) test...

Japanese researcher develops new pH image sensor
23 March 2012 A new pH image sensor for applications including the treatment of Alzheimer's disease has been developed by Kazuaki Sawada, a researcher at the Toyohashi University of Technology,...

Genomic reports positive results from Oncotype DX test trials
22 March 2012 Genomic Health has announced results of three new Oncotype DX studies, confirming the test's cost-effectiveness and impact on treatment decisions in early-stage invasive breast cancer patients...

OptiScanner helps monitor glucose levels in ICU patients
22 March 2012 OptiScan Biomedical has announced the positive clinical study results of its OptiScanner, an automated, bedside glucose monitoring system, for use in hospital intensive care units...

Gore enrols first Australian patients in endovascular aortic treatment registry
21 March 2012 W. L. Gore & Associates (Gore) has enrolled the first Australian patients at the Royal Prince Alfred Hospital, Camperdown, into the global registry for endovascular aortic treatment...

Benvenue starts enrolling patients for European LIFT study
21 March 2012 Benvenue Medical has started enrolling patients for its Luna interbody system for fusion trial (LIFT)...

FDA advisory panel to review Cameron S-ICD system PMA application
20 March 2012 The US Food and Drug Administration (FDA) Circulatory System Devices Panel will review Cameron Health's subcutaneous implantable defibrillator (S-ICD) system's premarket approval (PMA)...

Cytori Puregraft 850 system wins FDA nod
20 March 2012 The US Food and Drug Administration (FDA) granted 510(k) clearance for Cytori Therapeutics' Puregraft 850 System, used to contour a patient's body using their own...

Medtronic DBS therapy for epilepsy gets Health Canada licence
19 March 2012 US-based medical technology provider Medtronic has received a Health Canada licence for its deep brain stimulation (DBS) therapy for treating patients with refractory...

AppyScore blood test could diagnose acute appendicitis
19 March 2012 AspenBio Pharma has reported results from a pivotal clinical study of its AppyScore blood test, designed for the diagnosis of children and adolescents presenting abdominal...

ImThera sleep apnoea device now available in Europe after CE mark approval
16 March 2012 The European Commission has granted CE mark approval for ImThera Medical's aura6000 system, designed for the treatment of obstructive sleep apnoea...

Simpirica wins FDA clearance to commence LimiFlex device IDE study
16 March 2012 The US Food and Drug Administration (FDA) has paved the way for Simpirica Spine to initiate an investigational device exemption (IDE) pivotal clinical study for its LimiFlex spinal...

Sunshine Heart C-Pulse device meets FDA requirements
15 March 2012 Sunshine Heart announced that its C-Pulse heart assist system has met the requirements of the United States Food and Drug Administration (FDA) regulation 21CFR...

DFine treats first US patient using STAR ablation system
15 March 2012 DFine has successfully treated the first US patient with metastatic spinal tumours using its spinal tumour ablation with radiofrequency (STAR)...

Zynex takes over NeuroDyne Medical
14 March 2012 Zynex, through its subsidiary Zynex NeuroDiagnostics, has acquired all the assets of US-based NeuroDyne Medical for the sum of $320,000 payable at closing, with an additional $100,000 in...

Medtronic enrols first epilepsy patient in MORE registry
14 March 2012 Medtronic has enrolled the first patient at Kempenhaeghe-Heeze, the Netherlands, into the MedtrOnic Registry for Epilepsy (MORE) registry to evaluate the long-term efficacy, quality of life...

US surgery centre enrolls patients to evaluate AeroForm tissue expander
13 March 2012 Aesthetic Arts Institute of Plastic Surgery, US, is enrolling mastectomy patients into a clinical study to investigate a new tissue expansion method for women undergoing breast reconstruction...

Quidel Molecular RSV + hMPV diagnosis assay wins CE mark
13 March 2012 Quidel, a provider of rapid diagnostic testing solutions and cell-based virology assays, has received the CE mark for its Quidel Molecular RSV + hMPV assay for the identification of...

Hospira wins FDA approval for Symbiq infusion pump
12 March 2012 Hospira, a provider of injectable drugs and infusion technologies, has gained regulatory clearance from the US Food and Drug Administration (FDA) for its Symbiq 3.13 infusion device, the...

Icon's Nuloy coronary stent gets European clearance
12 March 2012 US-based medical device company, Icon Interventional Systems, has gained the CE mark for the Nuloy coronary stent system, used to treat patients with cardiovascular...

FDA clears Abbott Absolute Pro stent for iliac artery disease
09 March 2012 The US Food and Drug Administration (FDA) has approved Abbott's Absolute Pro vascular self-expanding stent system, intended for the treatment of iliac artery disease, a form of peripheral...

CardioKinetix reports positive data of Parachute implant
09 March 2012 CardioKinetix's Parachute ventricular partitioning device has showed positive data in the treatment of ischemic heart failure in a German sub-study of the Parachute Cohort B...

Abbott, Merck to develop companion diagnostic test for cancer
08 March 2012 Abbott will partner with Merck to evaluate the use of a fluorescence in situ hybridisation (FISH) based companion diagnostic test to aid the development of Merck's investigational cancer...

Covidien EverFlex peripheral stent wins FDA nod
08 March 2012 Covidien, a global provider of healthcare products, gained US Food and Drug Administration (FDA) approval for its EverFlex self-expanding peripheral stent system, for use in the superficial...

Avinger enrols first US patient in CONNECT II trial
07 March 2012 Avinger, a medical device manufacturer of multifunctional catheters, has enrolled the first US patient with peripheral artery disease (PAD) for the CONNECT II global clinical trial conducted at...

Medtronic wins CE mark for CapSure Sense MRI pacing leads
07 March 2012 Medtronic has received CE mark approval for its CapSure Sense MRI SureScan pacing...

Nobori stent reports safety, efficacy results in two year study
06 March 2012 Japan-based Terumo's Nobori drug eluting stent (DES) has demonstrated efficacy and long-term safety in the two-year large Nobori 2 study when used in high risk unselected...

Abbott, Genetics Laboratory to collaborate on diagnostic assay for infections
06 March 2012 Abbott said it will team with Genetics Laboratory to develop and commercialise the new molecular diagnostic test to detect microorganisms that cause serious infections in bones and...

Carestream mobile X-ray system gets Health Canada license
05 March 2012 Health Canada has issued a medical device license for Carestream Health's DRX-Revolution mobile X-ray system that enhances image quality, manoeuvrability and...

US researcher develops new melanoma detection device
05 March 2012 University of Missouri, Columbia, US, biomedical engineering and dermatology associate professor John Viator has developed a new medical diagnostic device to speed up the detection of...

Boston introduces Promus Element drug eluting stent in Japan
02 March 2012 Boston Scientific has launched its Promus Element everolimus-eluting platinum chromium coronary stent system in...

Ambry exome sequencing test found to diagnose genetic disorders
02 March 2012 Ambry Genetics has reported beneficial results from its Clinical Diagnostic Exome testing, used to diagnose individuals with genetic...

Medtronic Paradigm system meets efficacy endpoints in ASPIRE study
01 March 2012 Medtronic has reported positive efficacy results for its MiniMed Paradigm Real-Time Revel system from the in-clinic Automation to Simulate Pancreatic Insulin Response (ASPIRE)...

Critical Diagnostics' Presage ST2 assay predicts cardiac death
01 March 2012 Critical Diagnostics' Presage ST2 assay has demonstrated positive results in predicting sudden cardiac death in ambulatory chronic heart failure patients in a multicentre...

February 2012

Top

CASMED Fore-Sight oximeter wins FDA approval
29 February 2012 The US Food and Drug Administration (FDA) has approved CAS Medical Systems (CASMED) to market its Fore-Sight oximeter, designed to determine oxygen saturation of the abdomen of certain newborn...

MHRA calls for life-long checks on metal hip implants
29 February 2012 Patients with controversial metal-on-metal hip replacements may need annual checks for the life of the hip replacement to monitor problems, including exposure to toxic metals, according to...

Myriad's Prolaris assay found to detect prostate cancer
28 February 2012 Myriad Genetics' Prolaris test has demonstrated the prognostic ability in detecting prostate cancer in needle biopsy material, according to a study published in the British Journal of...

ATI begins European study of neurostimulation system
28 February 2012 Autonomic Technologies (ATI) commenced a European study to demonstrate the safety and efficacy of its investigational neurostimulation system, designed for the treatment of high frequency,...

Vessix treats patients with V2 renal denervation system
27 February 2012 Vessix Vascular has initiated patient treatment using its V2 renal denervation system in the international multicentre REDUCE-HTN renal denervation clinical study for uncontrolled...

Blue Belt Navio PFS system gets European approval
27 February 2012 The European Commission has granted CE Mark approval to Blue Belt Technologies' Navio precision freehand sculpting (PFS)...

NinePoint Medical commences Nvision VLE imaging system trial
24 February 2012 NinePoint Medical has started a clinical trial of its Nvision VLE imaging system, designed to evaluate high-resolution optical imaging of Barrett's esophagus, a condition that leads to...

Avinger enrolls first patient in European CONNECT II clinical trial
24 February 2012 Avinger, a medical device manufacturer of multifunctional catheters, has enrolled first the European patient, in Italy, for the CONNECT II global clinical...

Brainsway announces positive deep TMS device study results
23 February 2012 Brainsway has reported positive final results from a clinical trial investigating the efficacy of a deep transcranial magnetic stimulation (TMS) system to open the blood-brain barrier (BBB)...

Boston Scientific drug-eluting stent systems win FDA nod
23 February 2012 The US Food and Drug Administration (FDA) approved Boston Scientific's Ion paclitaxel-eluting platinum chromium coronary stent system and Taxus Liberte paclitaxel-eluting coronary stent system...

Sorin begins US study of stentless pericardial aortic valve
22 February 2012 Sorin Group has enrolled the first patient in the US investigational device exemption (IDE) study for its freedom solo stentless pericardial aortic...

CardioFocus treats first US patient using HeartLight ablation system
22 February 2012 CardioFocus has treated the first patient in the US pivotal trial intended to assess the safety and efficacy of the HeartLight endoscopic ablation system (EAS) in treating symptomatic...

ASI imaging for HER-2/neu analysis wins FDA approval
21 February 2012 The US Food and Drug Administration (FDA) has cleared Applied Spectral Imaging's (ASI) GenASIs automated scanning and image analysis...

Asuragen introduces miRInform pancreatic assay
21 February 2012 Asuragen has launched the miRInform pancreas test to aid clinicians in the diagnosis and management of pancreatic ductal adenocarcinoma (PDAC) when cytology is...

FDA approves Medtronic Resolute Integrity stent
20 February 2012 The US Food and Drug Administration (FDA) has approved Medtronic's Resolute Integrity™ drug-eluting stent (DES), designed for the treatment of coronary artery disease...

REVA Medical initiates patient enrolment in RESTORE trial
20 February 2012 REVA Medical has begun patient enrolment in Europe for the ReZolve™ sirolimus-eluting bioresorbable coronary scaffold RESTORE pilot study in addition to its primary site in Sao Paulo,...

Titan Medical, Columbia University to develop single port robotic surgery system
17 February 2012 Titan Medical and Columbia University have entered into an exclusive licence agreement to develop and commercialise a novel single port robotic surgery system, The Insertable Robotic...

MicroCHIPS announces positive trial data for microchip-based drug delivery device
17 February 2012 MicroCHIPS has announced the results of the first successful human clinical trial using an implantable, wirelessly controlled and programmable microchip-based drug delivery...

Gen-Probe prostate cancer assay gets FDA nod
16 February 2012 The US Food and Drug Administration (FDA) has cleared Gen-Probe's PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help demonstrate the need for repeat...

Delcath chemosaturation system gets Australian regulatory clearance
16 February 2012 The Therapeutic Goods Administration (TGA) division of the Australian government has approved Delcath Systems' Hepatic CHEMOSAT® delivery system for listing on the Australian Register...

FDA clears AngioDynamics' NeverTouch Direct procedure kit
15 February 2012 The US Food and Drug Administration has granted 510(k) clearance for AngioDynamics' NeverTouch Direct™ procedure kit for use with its VenaCure EVLT® laser vein ablation...

CardioSCORE assay could detect patients at high risk of cardiovascular events
15 February 2012 BG Medicine has announced positive results from the pivotal validation study of its CardioSCORE diagnostic blood test, which was formerly known as AMIPredict....

FDA clears Elekta Integrity R1.1 treatment control system
14 February 2012 Elekta, a human care company, has received 510(k) clearance from the US Food and Drug Administartion for its Integrity R1.1 device, which has been found to improve the speed and performance...

Medtronic begins Symplicity renal denervation system trials
14 February 2012 Medtronic has initiated two clinical programmes, SYMPLICITY-HF and Global SYMPLICITY Patient Registry, to demonstrate the clinical use of the company's Symplicity™ renal denervation system...

Forsyth, Quanterix, BIDMC to collaborate on TB test
13 February 2012 Quanterix Corporation, a developer of new generation molecular diagnostic tests, will join forces with Forsyth Institute and Beth Israel Deaconess Medical Center (BIDMC), to develop an...

Smith & Nephew reports trial data of BHR implant
13 February 2012 Smith & Nephew has announced the results of a new study conducted at The McMinn Centre in Birmingham, UK, evaluating the company's Birmingham Hip Resurfacing (BHR) system....

Endologix completes patient enrolment in PEVAR trial
10 February 2012 Endologix has concluded patient enrolment in the company's clinical trial of a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair...

Boston Scientific introduces TruePath CTO device in US
10 February 2012 Boston Scientific has introduced the TruePath™ CTO device in the US, designed to facilitate the crossing of chronic total occlusions (CTOs, or complete blockages) within the...

PositiveID begins glucose monitoring device trial
09 February 2012 PositiveID has begun a clinical trial of its Easy Check non-invasive breath glucose detection device, intended for use in people with...

Complete SE vascular stent found to treat atherosclerosis in SFA
09 February 2012 Medtronic has reported the one-year results from an international study of the Complete self-expanding (SE) vascular stent, designed for the treatment of atherosclerosis in the superficial...

Argus II retinal prosthesis system found to treat retinal pigmentosa
08 February 2012 Second Sight Medical Products' Argus II retinal prosthesis system has demonstrated improvements in blind people suffering from degenerative diseases, such as retinitis pigmentosa....

Boston Scientific introduces EUS aspiration needle
08 February 2012 Boston Scientific has announced the global launch of the Expect 19 flex endoscopic ultrasound aspiration needle, used for acquiring tissue samples under endoscopic ultrasound (EUS) guidance...

DINW introduces extremity MRI scanner in Northwest
07 February 2012 Diagnostic Imaging Northwest (DINW) has launched the new extremity 1.5 Tesla MRI scanner GE Optima in the...

MGuard shows superiority over bare metal stents: InspireMD reports
07 February 2012 InspireMD has reported the top-line clinical results from an investigator-sponsored controlled randomised trial of MGuard conducted in...

Spectranetics reports interim data from PATENT study
06 February 2012 Spectranetics has announced the six month interim results from the Photo-Ablation using the TURBO-Booster and Excimer Laser for In-Stent Restenosis Treatment (PATENT)...

Signal Genetics to acquire ChipDX
06 February 2012 Signal Genetics, a genetic testing company, has signed an agreement to acquire all the assets of New York based ChipDX, including patents for prognostic tests in lung, breast and colon...

Boston implants first patient with Promus Element stent
03 February 2012 Boston Scientific has announced the first European patient implant of its Promus Element Plus Stent System at the Columbus and San Raffaele Hospitals in Milan,...

Olive Medical unveils cost effective surgical imaging system
03 February 2012 US-based medical device company, Olive Medical, has launched the industry's first surgical camera system to enable surgical imaging at a lower...

AngioDynamics to take over Navilyst Medical
02 February 2012 AngioDynamics, a medical device provider, has signed a definitive agreement to acquire global medical device company Navilyst Medical from Avista Capital Partners for around...

FDA clears Roche CT/NG screening assay
02 February 2012 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Roche Molecular Diagnostics' cobas CT/NG test, used to detect chlamydia trachomatis (CT) and neisseria gonorrhoeae...

Endologix enrols first patient in Ventana device trial
01 February 2012 Endologix, a developer and marketer of innovative treatments for aortic disorders, has enrolled the first patient in the company's US clinical trial to evaluate the Ventana fenestrated stent...

CardioKinetix Parachute implant gets extended European approval
01 February 2012 The European commission has granted extended CE Mark approval for two additional sizes of CardioKinetix's Parachute ventricular partitioning device, used to treat patients with heart...

January 2012

Top

Global mobile health applications market to nearly double in 2012
31 January 2012 The global smartphone application market for mobile healthcare is expected to reach $1.3bn in 2012, up from $718m in 2011, according to a...

Gamma Therapeutics, Zeus Scientific partner to develop ELISA kits
31 January 2012 US-based early stage biotechnology venture Gamma Therapeutics has signed a manufacturing contract with Zeus Scientific, a manufacturer of autoimmune and infectious disease immunoassay kits...

US researchers develop new brain tumour diagnostic test
30 January 2012 Researchers at the UT Southwestern Medical Center, US, have developed a new imaging technique to diagnose brain tumours, avoiding the need for surgery in patients whose tumours are located in...

Accuray reports benefits of CyberKnife robotic radiosurgery system
30 January 2012 Accuray has announced the results of a study demonstrating the benefits of the CyberKnife robotic radiosurgery system in treating central lung tumours using stereotactic body radiotherapy...

FDA clears Interventional Spine intervertebral body fusion device
27 January 2012 The US Food and Drug Administration has approved Interventional Spine's Opticage expandable intervertebral body fusion device, used for the treatment of degenerative disc disease...

DiagnoCure announces colorectal cancer assay results
27 January 2012 DiagnoCure has announced that its partner for the Previstage GCC colorectal cancer staging test Signal Genetics has reported the results of a new study at the 2012 American Society of...

Medtronic enrols first patient in Arctic Front cardiac system comparison trial
26 January 2012 Medtronic has enrolled its first patient in the Fire and Ice clinical trial, which is designed to compare the long-term safety, effectiveness and ease of use of the Medtronic Arctic Front...

Boston IVF develops new saliva test to monitor infertility treatment
26 January 2012 Boston IVF, a medical practice centre providing specialised infertility treatment, has introduced the first needle-free saliva test that will replace the daily blood tests required to...

Covidien EverFlex stent meets safety and efficacy endpoints
25 January 2012 Covidien, a global provider of healthcare products, has reported the one-year results on the use of its EverFlex stent for superficial femoral artery stenting at the International Symposium...

Alere wins FDA CLIA waiver for rapid flu test
25 January 2012 Alere has received a clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its influenza A&B...

Amarantus licenses Power3 Medical NuroPro blood test
24 January 2012 US-based Amarantus BioSciences has licensed the NuroPro blood test from Power3 Medical...

Verisante presents positive Aura clinical study data
24 January 2012 Verisante Technology has announced positive data from the Aura clinical study conducted by the University of British Columbia (UBC),...

CardioComm heart monitoring device wins FDA nod
23 January 2012 CardioComm Solutions has gained marketing clearance from the US Food and Drug Administration (FDA) for its consumer-based, hand-held heart rhythm monitor, the HeartCheck Pen handheld...

FDA approves Quest STRATIFY JCV blood test
23 January 2012 The US Food and Drug Administration (FDA) has announced a de novo classification petition to Quest Diagnostics' STRATIFY JCV Antibody ELISA testing...

Sapheon Closure system shows efficacy in first in-man safety trial
20 January 2012 A medical adhesive and single-use catheter-based delivery system, designed to treat saphenous vein reflux disease, has demonstrated efficacy in a one year follow-up first in-man safety...

FDA clears Gore TAG for endovascular repair of TAA
20 January 2012 The US Food and Drug Administration (FDA) has approved W. L. Gore & Associates's Conformable Gore TAG for endovascular repair of isolated lesions of the thoracic aorta, including traumatic...

Medtronic Endurant stent graft receives European marketing approval
19 January 2012 Medtronic has received the CE Mark for its Endurant II AAA stent graft system, used to treat patients with abdominal aortic aneurysms (AAA) through a minimally invasive technique...

St Jude reports benefits of FFR-guided coronary treatment
19 January 2012 St Jude Medical's Fame II trial has found that fractional flow reserve (FFR)-guided assessment reduces the need for hospital readmission and urgent revascularisation in patients with...

Ventana and Bayer partner to develop diagnostic assay for cancer therapy
18 January 2012 Ventana Medical Systems, a member of the Roche Group, has signed a strategic partnership agreement with Bayer Pharma to develop a molecular companion diagnostic test for identifying patients...

Life Technologies and DaAn Gene form JV to develop IVD assays
18 January 2012 Life Technologies, a global biotechnology company, has entered into an agreement with China's in-vitro diagnostics (IVD) company DaAn Gene to form Life Technologies DaAn Diagnostics, a...

Boston reports positive results of Epic stent trial
17 January 2012 Boston Scientific has presented the positive results from the nine-month Orion trial, evaluating its Epic self-expanding nitinol stent system in patients with iliac artery disease, a form...

LINX reflux management system wins nod from FDA panel
17 January 2012 US-based medical device company Torax Medical has received a positive recommendation from the US Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Advisory Panel for...

Endosense introduces TactiCath 75 force-sensing catheter
16 January 2012 Endosense has launched the TactiCath 75 force-sensing ablation catheter in Europe, as well as results of the Efficas clinical study of contact force-sensing in catheter ablation procedures....

PLC Systems reports positive results of RenalGuard trial
16 January 2012 The Mythos investigator-sponsored clinical trial of PLC Systems' RenalGuard conducted in Italy has showed superiority in treating contrast-induced nephropathy (CIN) and in-hospital dialysis...

Biosense completes patient enrollment in SMART-AF trial
13 January 2012 Biosense Webster, a specialist in the diagnosis and treatment of cardiac arrhythmias, has completed patient enrollment in its SMART-AF Investigational Device Exemption study, designed to...

St.Jude pacemaker device predicts higher risk of stroke
13 January 2012 A study, sponsored by St. Jude Medical, has demonstrated the efficacy of pacemaker-based diagnostics in predicting hypertensive patients with a higher risk of...

St Jude reports efficacy results of DBS systems
12 January 2012 St Jude Medical's first controlled study on deep brain stimulation (DBS) confirms the benefits of a constant current system for patients with Parkinson's disease...

Agilent and Integrated Diagnostics partner to develop protein-based assays
12 January 2012 Agilent Technologies and Integrated Diagnostics have formed a strategic partnership to develop protein-based assays that detect major human diseases at an early...

FDA approves Neomend Progel extended applicator spray tip
11 January 2012 The US Food and Drug Administration (FDA) has granted premarket approval for Neomend's new Progel extended applicator spray tip, designed specifically for thoracic...

Ventana partners with Pfizer and CST to develop lung cancer diagnostic test
11 January 2012 Ventana Medical Systems has signed a collaboration agreement with Pfizer and a license agreement with Cell Signaling Technology (CST) to develop the first fully automated and...

Qiagen and MPIIB partner to develop tuberculosis diagnostic assay
10 January 2012 Qiagen and Max Planck Institute for Infection Biology (MPIIB) have partnered to develop a molecular diagnostic test to evaluate the risk of an individual with latent tuberculosis (TB)...

Smith & Nephew wound therapy system gets FDA clearance
10 January 2012 The US Food and Drug Administration (FDA) has cleared Smith & Nephew's pocket-sized PICO system, a single-use negative pressure wound therapy system for use both in a hospital and homecare...

Genous stent shows efficacy in dual antiplatelet therapy patients
09 January 2012 OrbusNeich has announced that 12-month follow-up data from a post-hoc analysis of the e-HEALING registry has revealed that its Genous stent achieved good and comparable clinical and safety...

VisionGate automates 3D cancer detecting system
09 January 2012 VisionGate, a developer of non-invasive tests for the early detection of lung cancer, has achieved full automation of its Cell-CT system, a proprietary imaging platform that...

NinePoint Medical VLE imaging system wins FDA nod
06 January 2012 NinePoint Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Nvision VLE imaging system, a next-generation, high-resolution optical imaging...

GI Dynamics introduces EndoBarrier device in the Netherlands
06 January 2012 GI Dynamics has announced the commercial launch of the EndoBarrier gastrointestinal liner, a non-surgical device designed for the treatment of type 2 diabetes and obesity, in the...

BioLineRx commences BCM CE mark registration trial
05 January 2012 BioLineRx has begun a CE Mark registration trial, Preservation I, of Bioabsorbable Cardiac Matrix (BCM, BL-1040), a novel medical device designed to prevent cardiac remodelling following an...

Medtronic launches remote glucose monitor in the US
05 January 2012 Medtronic has launched its mySentry remote glucose monitor in the US following approval from the Food and Drug Administration...

SeptRx enrols patients in InterSEPT trial
04 January 2012 SeptRx has concluded enrolment of the first 20 patients in its ongoing InterSEPT clinical trial at Sankt Katharinen Hospital in Frankfurt,...

InSightec concludes patient enrolment in MRgFUS feasibility trial
04 January 2012 InSightec has completed patient enrolment in the first feasibility study assessing the use of MR-guided focused ultrasound (MRgFUS) for treatment of essential tremor using ExAblate Neuro at...

Mindframe's Capture LP devices get European approval
03 January 2012 The European regulatory commission has granted the CE mark for MindFrame's new series of Capture low-profile (LP) devices, intended for treatment of ischaemic...

Critical Diagnostics assay help predict mortality risk in heart patients
03 January 2012 US-based biomarker company Critical Diagnostics has announced that Hospital Germans Trias i Pujol in Barcelona, Spain, is using its Presage ST2 assay for routine care and management of...

December 2011

Top

Australian TGA approves Uptake InterVapor system
23 December 2011 Uptake Medical has received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor system, designed for endoscopic lung volume reduction as a treatment for patients...

BD Flu A+B detection system gets FDA nod
22 December 2011 Becton, Dickinson and Company has received the US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its BD Veritor system...

Reva initiates patient enrolment for coronary scaffold trial
22 December 2011 Reva Medical has commenced patient enrolment in a pilot study designed to investigate its ReZolve bioresorbable sirolimus-eluting coronary...

Cerevast stroke treatment device gets European marketing approval
21 December 2011 Cerevast Therapeutics' Clotbust ER, a sonoLysis headframe system used to treat ischaemic stroke in emergency room settings, has received CE mark...

Devon Medical brain access system wins Chinese approval
21 December 2011 Developed in US by Vycor Medical, VBAS is a brain access and retraction device that provides higher precision for surgeons in reaching target areas in the brain in a minimally invasive...

Verisante skin cancer detection system wins Australian approval
20 December 2011 Verisante Technology, a specialist in skin cancer detection technology, has received Australian regulatory approval to commercialise Verisante Aura, an innovative, non-invasive medical device...

Metabolomx colorimetric sensor array could detect lung cancer
20 December 2011 Metabolomx has announced the results from a clinical study evaluating its first-generation colorimetric sensor array, which can detect and differentiate types of lung cancer in...

FDA clears Presage ST2 assay for cardiovascular disease
19 December 2011 US-based biomarker company Critical Diagnostics has received US Food and Drug Administration (FDA) approval for its Presage ST2 assay, which is used to help determine the prognosis of...

AtriCure Synergy ablation system wins FDA nod
19 December 2011 AtriCure has received US Food and Drug Administration (FDA) clearance for its Synergy ablation system, used to treat persistent and long-standing persistent atrial fibrillation during...

Honeywell introduces triage solution for emergency responders
16 December 2011 Honeywell has released a new technology solution, Safe Triage Pro, to help emergency responders provide faster and more accurate on-scene support and diagnosis....

Pathwork reports Tissue of Origin test clinical utility
16 December 2011 Pathwork Diagnostics has reported study results that confirming the clinical utility of the Pathwork Tissue of Origin test in diagnosing challenging cancer...

VertiFlex completes patient enrolment in Superion IDE trial
15 December 2011 VertiFlex, a developer of minimally invasive and motion-preserving spinal surgery technologies, has concluded patient enrolment in its pivotal IDE clinical trial of the Superion Interspinous...

AngioScore enrols patients in drug-coated AngioSculpt balloon catheter trial
15 December 2011 AngioScore, a developer of angioplasty catheters, has commenced patient enrolment in its drug-coated AngioSculpt scoring balloon catheter first-in-human (FIH)...

St Jude Medical implants first patient with Portico transcatheter aortic valve implant
14 December 2011 US-based St. Jude Medical has implanted the first patient with its Portico transcatheter aortic valve implant in a European clinical...

FDA clears Meridian illumigene GBS assay
14 December 2011 Meridian Bioscience has received US Food and Drug Administration (FDA ) clearance for a new molecular diagnostic test for Group B Streptococcus (GBS) on the illumigene...

New York approves Rosetta Genomics miRview mets^2 test
13 December 2011 Rosetta Genomics has received approval from the New York State Department of Health to use miRview mets^2 testing on patient tumour...

Aptus HeliFX system found to fix aortic endografts
13 December 2011 Aptus Endosystems, a medical device company that develops advanced technology for endovascular aneurysm repair, has successfully treated the first series of patients in the US with its...

Medtronic neurostimulation system found effective in chronic pain treatment
12 December 2011 Medtronic's AdaptiveStim with RestoreSensor neurostimulation system has been found to be more effective at treating chronic back or leg pain than conventional...

Abbott begins Phase II trial of Absorb bioresorbable vascular stent
12 December 2011 Abbott has commenced Absorb II clinical trial, which will investigate the safety, efficacy and performance of its Absorb bioresorbable vascular stent against its Xience Prime...

Echo reports positive results of glucose monitoring system
09 December 2011 Echo Therapeutics has announced the positive results from a clinical study of its Symphony transdermal continuous glucose monitoring system in patients with type 1 and type 2...

DFine wins approval to launch StabiliT system in Canada and Mexico
09 December 2011 DFine has received clearance to introduce its StabiliT RadioFrequency Targeted Vertebral Augmentation system throughout Canada and Mexico...

Genomic Oncotype breast cancer test to predict risk of recurrence
09 December 2011 Genomic Health's Oncotype DX has met its primary endpoint in a clinical validation study investigating patients with ductal carcinoma in situ (DCIS), a type of breast...

Xeltis to commence tissue-engineered vascular grafts trial
09 December 2011 Biomedical technology company Xeltis has received conditional approval from the Paul Erlich Institute in Germany to initiate the first clinical study of its tissue-engineered cardiovascular...

Apollo signs MoU to test Titan robotic surgical technologies
08 December 2011 Titan Medical and India's Apollo Hospitals Enterprise has signed a non-binding memorandum of understanding (MoU), which is being facilitated by PrimeSource MedTech, a medical device...

Estech enrols patients in staged hybrid ablation study
08 December 2011 Estech has announced that the first three patients with persistent and long-standing persistent atrial fibrillation (AF) have been enrolled in the HISTORIC-AF European multicentre staged...

Sorin Group adult oxygenator wins European approval
08 December 2011 Sorin Group, a global medical device company, has received European approval for its Inspire oxygenator system, designed for cardiopulmonary bypass procedures in adult...

OrbusNeich presents safety profile of Genous stent
08 December 2011 OrbusNeich's Genous stent was found to be safe when combined with a ten-day dual antiplatelet therapy (DAPT) in the multicentre...

AirXpanders treats first patient in XPAND trial
07 December 2011 AirXpanders has treated the first mastectomy patient undergoing breast reconstruction in the AirXpanders patient activated controlled tissue expander system for breast reconstruction (XPAND)...

Roche cobas EGFR mutation assay gets European approval
07 December 2011 Swiss-based Roche has received CE mark approval for its companion diagnostic cobas epidermal growth factor receptor (EGFR) mutation test to treat non-small-cell lung cancer...

NSF funds UA researchers' development of new imaging device
07 December 2011 The National Science Foundation (NSF) has awarded a $530,000 grant to the University of Arizona (UA) College of Engineering, US, to develop a terahertz spectral...

Quidel Sofia fluorescent immunoassay wins CE mark
07 December 2011 Quidel, a diagnostic testing solutions provider, has received CE mark approval for its Sofia strep A fluorescent immunoassay (FIA) test for use with its Sofia...

FDA clears Covidien SpiderFX embolic protection device
06 December 2011 The US Food and Drug Administration (FDA) has cleared Covidien's SpiderFX device, indicated for use in arteries in the lower extremities to treat severely calcified...

Inova Labs oxygen concentrator system gets CE Mark
06 December 2011 US-based Inova Labs, developer of products to treat chronic obstructive pulmonary disease, has received the CE Mark for its LifeChoice portable oxygen concentrator...

Researchers develop blood test for membranous nephropathy
06 December 2011 Researchers at Boston University School of Medicine and Boston Medical Center have developed a blood test to diagnose membranous nephropathy in its early...

Wound Management Technologies to acquire Juventas
06 December 2011 Wound Management Technologies has signed a letter of intent to acquire US-based medical device distributor...

Quanterix to develop botulinum toxin assay
05 December 2011 Quanterix has entered into a collaboration agreement with the Botulinum Research Center to develop and validate an assay to measure low levels of the botulinum toxin within complex...

Boston gets FDA clearance for new cardiac devices
05 December 2011 Boston Scientific has received US Food and Drug Administration (FDA) approval for its Incepta, Energen, and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and...

Cytori Celution One system gets European approval
05 December 2011 Cytori's Celution One system, intended for hospitals as a platform device with life-critical applications across multiple specialties, has been granted the CE...

Cognizant wins multi-year contract from AstraZeneca
05 December 2011 Business process outsourcing services provider Cognizant has signed a multi-year agreement with AstraZeneca to deliver comprehensive biostatistics and medical reporting...

Uptake Medical treats first patient with InterVapor system
02 December 2011 Uptake Medical has treated the first patient using its InterVapor system, designed for endoscopic lung volume reduction in patients with severe...

St Jude CRT-D and pacing lead gets FDA clearance
02 December 2011 St Jude Medical has received US Food and Drug Administration (FDA) approval for its Unify Quadra cardiac resynchronisation therapy defibrillator (CRT-D) and Quartet left ventricular...

Staar astigmatism lenses get Japanese marketing approval
02 December 2011 The Japanese Ministry of Health, Labour and Welfare has cleared Staar Surgical's Visian Toric implantable Collamer lens (ICL) for the treatment of myopia and...

Covidien Endo Stitch suturing device found effective against benign conditions
02 December 2011 Covidien's Endo Stitch automated suturing device delivers a reduction in mean hospital costs and operating room time during total laparoscopic hysterectomies to treat benign conditions, a study...

Neuros gets FDA approval begin electrical nerve block technology study
01 December 2011 The US Food and Drug Administration (FDA) has granted Neuros Medical investigational device exemption approval to initiate a pilot clinical trial to investigate its patented...

UK researchers develop new blood-pressure monitor
01 December 2011 Researchers at the University of Leicester in the UK have developed a new wristwatch device to monitor blood pressure in collaboration with HealthStats, a Singaporean biotechnology...

Sapiens secures funding to develop deep-brain stimulation therapy
01 December 2011 Sapiens Steering Brain Stimulation has received a €3.5m (£3m) award from Wellcome Trust to develop next-generation deep-brain stimulation...

Avita Medical acquires intellectual property rights from McComb Foundation
01 December 2011 Avita Medical has successfully completed the transfer and acquisition of intellectual property from the Australia-based McComb...

November 2011

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Toshiba America Medical Systems introduces Aquilion imaging system
30 November 2011 Toshiba America Medical Systems has introduced its new Aquilion Prime CT at the Radiological Society of North America's annual meeting in Chicago,...

FirstMark PREvent blood assay could diagnose coronary artery disease
30 November 2011 FirstMark, a diagnostic division of GenWay Biotech, has presented the study results for PREvent, a multiple biomarker test that diagnoses near term risk of myocardial infarction for suspected...

FDA clears Philips' whole-body PET/MR imaging system
30 November 2011 Royal Philips Electronics' whole body PET/MR imaging system, the Ingenuity TF PET/MR, has received 510(k) clearance from the US Food and Drug Administration...

Ansell acquires minority stake in Yulex
30 November 2011 Ansell, a provider of health and safety protection solutions, has purchased a minority share of Yulex, a manufacturer of bio-based elastomer products derived from...

Proteome develops in-vitro assays to treat allergies
29 November 2011 Proteome Sciences has developed in-vitro assays to treat allergies associated with the skin and respiratory system that are induced by chemical compounds and...

Allergan introduces silicone gel-filled breast implants in Canada
29 November 2011 Multi-speciality healthcare company Allergan has developed a new silicone gel-filled breast implant and introduced it in...

New airflow control device found to reduce asthma symptoms
29 November 2011 According to a study published in medical journal Thorax, asthma patients can improve their quality of life and reduce persistent symptoms during the day by using a simple bedside...

US researchers develop new device for urinary problems
29 November 2011 Case Western Reserve University in the US is developing a neurotechnology device to treat patients suffering from urinary problems due to spasms in the urethral...

Biotronik implants first patients with new Lumax 740 ICDs
28 November 2011 Biotronik has implanted the first patients with its new Lumax 740 implantable cardiac defibrillator (ICD), the first such device suitable for use with...

Philips launches Veradius Neo mobile C-arm
28 November 2011 Royal Philips Electronics has introduced its new Philips Veradius Neo mobile C-arm to enhance patient...

BD MAX MRSA assay gets European approval
28 November 2011 BD Diagnostics has received the CE mark for an assay to identify patients infected with...

Boston's Promus Element Stent gets FDA nod
28 November 2011 The US Food and Drug Administration (FDA) has approved Boston Scientific's Promus Element plus everolimus-eluting platinum chromium coronary stent...

Sphere Medical's Proxima blood analyser meets primary endpoint
25 November 2011 Sphere Medical's Proxima Generation 2 has met its primary endpoint in a multicentre clinical trial conducted at two UK hospitals, Queen Elizabeth Hospital Birmingham and West Suffolk...

FDA approves Medtronic continuous glucose monitoring system
25 November 2011 Medtronic has received US Food and Drug Administration (FDA) approval for its iPro2, a next-generation continuous glucose monitoring...

FSS enrols first patients in FlexStent studies
25 November 2011 Flexible Stenting Solutions (FSS) has enrolled the first patients in two trials of its FlexStent, a femoropopliteal stent and delivery system....

3D Systems to acquire Vidar Systems and Z Corporation
25 November 2011 3D Systems has signed an agreement to purchase Contex Group subsidiaries Vidar Systems and Z Corporation for...

Genesis to produce Future Path urine-management bag
24 November 2011 Genesis Plastics Welding has announced that it will manufacture Future Path Medical's iBag urine-management...

FDA clears Abbott Chagas disease test
24 November 2011 The US Food and Drug Administration has approved a test developed by Abbott Laboratories to detect antibodies to Trypanosoma cruzi, the cause of Chagas...

Aptus EndoStapling system gets FDA nod
24 November 2011 Aptus Endosystems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HeliFX aortic securement...

Covidien to acquire Barrx Medical
24 November 2011 Covidien has signed a definitive agreement to acquire all outstanding capital stock of Barrx Medical for around...

SuperNova and Concile to develop point-of-care diagnostic test
23 November 2011 SuperNova Diagnostics has entered into a commercial partnership with European specialist healthcare distributor Concile to develop the point-of-care diagnostic test for assessing...

Cervilenz device receives CE mark
23 November 2011 Cervilenz Inc has received the CE mark for its CerviLenz device, designed to measure vaginal cervical...

Deep brain stimulation therapy show promise in depression treatment
23 November 2011 The multicentre pilot study of the Libra deep brain stimulation system for major depressive disorder has demonstrated improvement in symptoms among patients who are highly treatment...

BSD cancer treatment system gets FDA approval
23 November 2011 The US Food and Drug Administration (FDA) has granted humanitarian device exemption marketing approval to BSD Medical's BSD-2000 hyperthermia...

Sanuwave dermaPACE found effective against diabetic foot ulcers
22 November 2011 Sanuwave Health has presented positive data from its Phase III clinical trial of dermaPACE, used as a treatment for diabetic foot...

CerMed cervical specimen collection device wins CE mark
22 November 2011 CerMed International has received CE mark approval for its CerMap cervical specimen collection...

FDA clears Medtronic pain management system
22 November 2011 The US Food & Drug Administration (FDA) has approved Medtronic's AdaptiveStim with RestoreSensor neurostimulation system for the management of chronic...

AtriCure completes patient enrollment in DEEP AF trial
22 November 2011 AtriCure has completed patient enrolment in its DEEP AF feasibility trial, designed to assess the safety and efficacy of integrating the company's minimally invasive products in the treatment...

Boston implants first patient with left atrial appendage closure device in Colombia
21 November 2011 Boston Scientific's Watchman left atrial appendage closure device has been implanted in the first group of patients at Angiografia de Occidente in Cali,...

Spiracur begins SNaP wound care system study
21 November 2011 Spiracur has initiated a study to evaluate its SNaP wound care system to treat lower extremity diabetic, venous and mixed etiology wounds at Cardiff University School of...

FDA clears PositiveID diabetes management system
21 November 2011 PositiveID has received US Food and Drug Administration (FDA) clearance for its iglucose mobile health system for diabetes...

CorMatrix gets FDA approval to begin CorMatrix ECM trial
21 November 2011 The US Food and Drug Administration (FDA) has granted investigational device exemption approval to CorMatrix Cardiovascular for an ongoing, multicentre, prospective and randomised clinical trial...

X-spine spinal implant system gets FDA approval
18 November 2011 The US Food and Drug Administration has approved X-spine's Calix PC spinal implant system, an intervertebral body fusion system designed to treat spinal...

Landauer acquires IZI Medical Products
18 November 2011 Landauer, a provider of personal and environmental radiation monitoring services, has acquired all outstanding equity interests of US-based IZI Medical Products for around...

CardioDx gene-expression performs well in trial
18 November 2011 CardioDx's Corus CAD blood-based gene expression test has demonstrated superior performance in a...

DFine commences StabiliT vertebral augmentation system trial
18 November 2011 DFine, a developer of minimally invasive radiofrequency targeted therapies, has begun a prospective and randomised study to investigate the clinical effectiveness of minimally invasive...

Abbott Absorb drug-eluting scaffold found to restore blood flow
17 November 2011 Abbott has presented positive long-term data from a two-stage, prospective and non-randomised trial investigating the Absorb drug-eluting bioresorbable vascular scaffold as a treatment for...

Torax continence restoration system wins CE mark
17 November 2011 Torax Medical has received the CE mark for its Fenix continence restoration...

MDxHealth prostate cancer assay shows efficacy
17 November 2011 MDxHealth's Prostate ConfirmMDx test has been found to help urologists to distinguish between true negative biopsies and occult prostate cancers undetected by biopsy and histopathological review....

Telecare solutions maker wins UKTI competition
17 November 2011 Geonovo, a developer of telecare solutions and mobile GPS alarms, has won a UK Trade & Investment (UKTI)...

St Mary's Hospital in London performs surgery with Hansen Magellan Robotic System
16 November 2011 Hansen Medical's Magellan Robotic System has been used for the first time at St Mary's Hospital for the treatment of peripheral vascular...

Elixir initiates DESolve bioresorbable coronary system study
16 November 2011 Elixir Medical has begun patient enrolment in an international pivotal clinical study to assess the safety and efficacy of its DESolve novolimus-eluting bioresorbable coronary scaffold system...

Boston PolarCath dilatation system found to reduce restenosis rate
16 November 2011 Boston Scientific's PolarCath peripheral dilatation system has demonstrated positive results from the COBRA clinical trial, which investigated post-dilation of nitinol stents using CryoPlasty...

BioVentrix completes enrolment in heart failure treatment system trial
16 November 2011 BioVentrix has completed patient enrolment in a pilot human clinical trial of its PliCath HF heart failure treatment...

St Jude reports positive transcatheter heart valve results
15 November 2011 St Jude Medical has presented positive results from a feasibility study of its Portico transcatheter aortic heart valve, conducted at Royal Victoria Hospital in Belfast, Northern...

Biotronik Pantera Lux paclitaxel-releasing balloon meets endpoint
15 November 2011 Biotronik has announced the positive six-month results from the DELUX registry and 12-month results from the PEPPER study of its Pantera Lux paclitaxel-releasing...

FDA clears Idev transhepatic biliary stent system
15 November 2011 The US Food and Drug Administration (FDA) has granted 510(k) clearance for Idev Technologies' 6 French (6Fr) Supera Veritas transhepatic biliary stent...

Abbott new hepatitis assay gets CE mark
15 November 2011 Abbott's Architect hepatitis B surface antigen (HBsAg) diagnostic test has been awarded the CE...

Verisante skin cancer detection system wins CE mark
14 November 2011 Verisante Technology has received the Conformite Europeenne (CE) mark for its Verisante Aura, used to diagnose skin...

New Electronic Nose could detect tuberculosis
14 November 2011 Researchers from the International Centre for Genetic Engineering and Biotechnology (ICGEB), India, and Next Dimension Technologies US, have developed a new hand-held breathalyser for...

Westhouse Medical acquires Battlebridge cancer screening patents
14 November 2011 Westhouse Medical Services has purchased the US and UK patents for the Profemme breast cancer screening technology from Battlebridge Group for...

Medtronic Aquamantys system found to lower blood loss during surgery
14 November 2011 Medtronic has announced the results from a retrospective study of its Aquamantys system that demonstrated the efficacy in limiting blood loss and reducing transfusions during spinal...

FDA clears Femasys low-pressure hysterosalpingography device
11 November 2011 Femasys has received US Food and Drug Administration (FDA) clearance for its FemChec pressure management device, designed to deliver a low-pressure hysterosalpingography as a confirmation...

Carotid Wallstent found to provide safe carotid artery stenting
11 November 2011 Boston Scientific's carotid Wallstent Monorail endoprosthesis with FilterWire EZ Embolic protection system has been found to be safe for high surgical risk patients in routine clinical...

Svelte treats first patient in DIRECT study
11 November 2011 Svelte Medical Systems has treated its first patient at Auckland City Hospital in Auckland, New Zealand, in the DIRECT...

Micell reports positive DESSOLVE I study data
11 November 2011 Micell Technologies has announced the preliminary data from the DESSOLVE I study of the MiStent Sirolimus drug-eluting coronary stent...

NIH funds Kensey Nash for tendon product research
10 November 2011 The National Institutes of Health (NIH) has awarded a two-year, $1.9m Phase II small business innovation research grant to Kensey Nash, to further evaluate the use of a bioadhesive surgical...

Medtronic direct aortic therapy system gets CE mark
10 November 2011 Medtronic has received the CE mark for its CoreValve system, used for direct aortic and subclavian transcatheter aortic valve implantation in patients with severe aortic...

Sunshine C-Pulse system found effective against cardiovascular disorder
10 November 2011 Sunshine Heart has presented the results of a US Food and Drug Administration-approved feasibility study of the C-Pulse heart assist...

Maquet Cardiovascular acquires Atrium Medical
10 November 2011 Maquet Cardiovascular has secured US Federal Trade Commission approval to acquire Atrium Medical, a developer of medical device technologies for interventional cardiology and radiology,...

Terason introduces new portable ultrasound system
09 November 2011 Terason, a diagnostic ultrasound technology company, has introduced the new Terason t3200 vascular series ultrasound system, which is expected to quicken the pulse of vascular...

K2M develops two new spinal fusion treatment systems
09 November 2011 K2M, a spinal device company, has developed two new solutions for the treatment of complex spinal pathologies, the Aleutian Transforaminal-Lumbar II interbody system and...

TATRC funds PhysioSonics to optimise cerebral blood-flow monitor
09 November 2011 PhysioSonics has received a $2.5m grant from the Telemedicine and Advanced Technology Research Center (TATRC) to optimise its proprietary cerebral blood-flow monitor to detect...

Johnson & Johnson company acquires SterilMed
09 November 2011 Ethicon Endo-Surgery, a Johnson & Johnson company, has acquired SterilMed, which is involved in the reprocessing and remanufacturing of single-use medical devices in the...

Solta Medical weight reduction system receives Health Canada clearance
08 November 2011 Solta Medical has received Health Canada clearance for its second-generation LipoSonix system, designed for non-invasive waist circumference...

Thoratec enrolls first patient in left ventricular assist system study
08 November 2011 Thoratec has enrolled the first patient in a study intended to evaluate and compare the effectiveness of the HeartMate II left ventricular assist system as a destination therapy device in...

Asuragen pancreatic cancer assay found effective
08 November 2011 Asuragen's microRNA-based test, miRInform Pancreas, has demonstrated improvements in the diagnosis of pancreatic ductal...

TriVascular abdominal stent graft gets FDA approval
08 November 2011 The US Food and Drug Administration (FDA) has approved TriVasculars' Ovation abdominal stent graft system to treat abdominal aortic...

Quanterix PSA assay proven effective
07 November 2011 Quanterix's fifth-generation digital immunoassay prostate specific antigen (PSA) test, demonstrated a 2-log improvement in sensitivity to measure PSA levels in patients following a...

FDA approves Edwards transcatheter aortic heart valve
07 November 2011 The US Food and Drug Administration (FDA) has cleared Edwards Lifesciences' Sapien transcatheter aortic heart valve, designed to treat inoperable patients with severe symptomatic aortic...

SpyGlass system demonstrates effectiveness in bile duct disease diagnosis
07 November 2011 Boston Scientific's SpyGlass direct visualisation system, a single-operator cholangioscopy device, has demonstrated an overall procedural success rate of 89% in diagnosing bile duct...

Medtronic commences transcatheter valve trial
07 November 2011 Medtronic has implanted the first patient with its CoreValve system in a clinical trial in...

Quest to introduce new influenza test in Europe
04 November 2011 Quest Diagnostics is to introduce the new Simplexa Flu A/B & RSV Direct test in...

Brainsway gets FDA approval to begin bipolar disorder trial
04 November 2011 Brainsway has received investigational device exemption approval from the US Food and Drug Administration (FDA) to initiate a multicentre clinical trial to investigate the efficacy of its...

SMSI secures funding to develop glucose-monitoring system
04 November 2011 Sensors for Medicine and Science (SMSI) has secured $54m in Series D equity financing to develop and commercialise an implantable, long-term continuous glucose monitoring system, used to...

FDA approves Abbott's Xience Prime drug-eluting stent
04 November 2011 The US Food and Drug Administration (FDA) has approved Abbott's next-generation Xience Prime everolimus-eluting coronary stent system, used to treat coronary artery...

Everist Genomics acquires Angiologix
03 November 2011 Everist Genomics has acquired Angiologix, the developer of the AngioDefender diagnostic device for assessing endothelial function....

Medtronic's Assurant stent gets FDA nod
03 November 2011 Medtronic has received US Food and Drug Administration (FDA) clearance for its Assurant cobalt iliac balloon-expandable stent system, designed to treat narrowed iliac...

FDA clears new Gen-Probe HPV assay
03 November 2011 The US Food and Drug Administration (FDA) has approved Gen-Probe's Aptima human papillomavirus (HPV) assay, used to diagnose cervical...

Spine Wave initiates NuCore injectable nucleus device study
03 November 2011 Spine Wave has begun a clinical study to determine the feasibility of implanting its NuCore injectable nucleus device using a proprietary percutaneous technique to treat degenerative disc...

EarlySense to introduce new patient monitoring system at MEDICA 2011
02 November 2011 EarlySense will unveil a new contact-free patient monitoring system at MEDICA 2011 in Düsseldorf, Germany, which will be held on 16-20...

Sensei and Ideal Life partner for wireless health devices
02 November 2011 Sensei has partnered with Ideal Life to integrate Ideal Life's wireless heath devices into the Sensei Connect platform....

Medtronic gets FDA approval to begin diabetes device study
02 November 2011 Medtronic has received investigational device exemption approval from the US Food and Drug Administration (FDA) to conduct a pivotal in-home study using its MiniMed Paradigm...

FDA approves two Spinal USA spinal fusion products
02 November 2011 Spinal USA has received US Food and Drug Administration (FDA) 510(K) clearance for its new VAULT stand-alone ALIF system and S-Lok PC posterior cervical...

FDA approves Stealth Therapeutics implantable arm port
01 November 2011 The US Food and Drug Administration (FDA) has granted approval for Stealth Therapeutics' Invisiport implantable arm port, intended for use in patients requiring long-term intravenous...

Stellar partners with Life Diagnostics to develop ELISA test kits
01 November 2011 Stellar Biotechnologies has entered into a manufacturing and supply agreement with Life Diagnostics to develop Stellar brand keyhole limpet haemocyanin ELISA test kits, used to detect...

Spineology develops new pedicular fixation system
01 November 2011 Spinal implants and instruments maker Spineology has developed a new, minimally invasive pedicular fixation...

Apnex sleep apnoea treatment system wins European approval
01 November 2011 Apnex Medical has gained CE Mark approval for its hypoglossal nerve stimulation system, used to treat patients with obstructive sleep...

October 2011

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Tryton Medical completes patient enrollment for Tryton IDE Study
31 October 2011 Tryton Medical has completed patient recruitment in the intravascular ultrasound (IVUS) group of the Tryton IDE Study, investigating the Tryton side branch stent, built on its Tri-zone...

Exonhit secures IRB approval to begin AclarusDx test trial
31 October 2011 Exonhit has received an Institutional Review Board (IRB) approval to start a 160-patient pilot clinical trial to evaluate the clinical utility of AclarusDx, a blood-based test as a diagnostic...

Medtronic enrolls first patient for Symplicity HTN-3 clinical trial
31 October 2011 Medtronic has enrolled the first patient at the Prairie Heart Institute, St. John's Hospital in Springfield, US, in the Symplicity HTN-3 clinical trial of the Symplicity Renal Denervation...

FDA clears Quidel analyser and influenza assay
31 October 2011 Quidel, a rapid diagnostic testing solutions and cell-based virology assays provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia analyser and...

OrbusNeich Genous stent proven effective in study
28 October 2011 Twelve-month follow-up data from a clinical trial of OrbusNeich's Genous stent has revealed that the device is safe and...

Accuray wins FDA clearance for Dose Control System
28 October 2011 Radiation oncology company Accuray has been granted US Food and Drug Administration (FDA) approval for the Dose Control System, a new feature for the company's TomoTherapy...

Microline Surgical acquires Starion Instruments
28 October 2011 US-based Microline Surgical has acquired Starion Instruments, a developer of surgical technology to seal and divide soft...

Interface Biologics signs licensing agreement with Navilyst
28 October 2011 Interface Biologics has signed a definitive licence and supply agreement with Navilyst Medical, a leading manufacturer of image-guided medical...

Zygo wins contract to develop extreme ultraviolet optics for MET-5
27 October 2011 Zygo's optical systems division has received a $9m contract to develop extreme ultraviolet lithography optics for the fifth-generation micro-exposure tool...

CryoLife enrols first patient in BioFoam trial
27 October 2011 CryoLife has enrolled the first patient in a US investigational device exemption trial for its BioFoam surgical matrix, designed for cellular aggregation and enhanced...

FDA clears Abbott AML diagnostic test
27 October 2011 The US Food and Drug Administration (FDA) has granted approval for an in vitro diagnostic test to determine the prognosis of patients with acute myeloid leukaemia...

Medicis Technologies LipoSonix system gets FDA clearance
27 October 2011 Medicis Pharmaceutical's subsidiary Medicis Technologies has received US Food and Drug Administration (FDA) clearance for its second generation LipoSonix system, designed for non-invasive...

PSA test could predict low-risk prostate cancer, says study
26 October 2011 A study by Mayo clinic has found that the prostate-specific antigen (PSA) test could be a vital tool in predicting which men should have biopsies and which are likely to be diagnosed with...

NeuroSigma to fund ADHD nerve stimulation trial
26 October 2011 NeuroSigma has signed a contract with the University of California, Los Angeles to fund a paediatric trial to investigate a non-invasive, external trigeminal nerve stimulation as a treatment...

OncoSec submits device master file to FDA
26 October 2011 OncoSec Medical, a developer of OMS ElectroOncology therapies for the treatment of solid-tumour cancers, has submitted the device master file for its patented OncoSec Medical System to the US...

Sonitus unveils new hearing device
26 October 2011 Sonitus Medical unveiled its SoundBite hearing system, a non-surgical and removable hearing prosthetic to treat single-sided deafness and conductive hearing...

Sorin Group enrolls first patient in ISIS-ICD clinical trial
25 October 2011 Sorin Group has enrolled the first patient in its ISIS-ICD clinical trial, designed to evaluate the percentage of patients implanted with an implantable cardioverter-defibrillator featuring...

Bolton completes enrolment in abdominal stent-graft trial
25 October 2011 Bolton Medical has completed patient enrolment in a Phase I trial designed to evaluate the safety and efficacy of the Treovance abdominal stent-graft with the Navitel delivery system in...

FDA clears Canon TX-20 tonometer
25 October 2011 Canon USA's TX-20 Full Auto Tonometer has received 510(k) clearance from the US Food and Drug Administration...

Covidien reports six-month plaque excision study results
25 October 2011 Covidien has reported six-month results from a study assessing the effectiveness of plaque excision as a frontline therapy for the treatment of peripheral arterial...

Hansen Medical begins study of robotic catheter system
24 October 2011 Hansen Medical has initiated a study to evaluate its flexible catheter Sensei X robotic system in patients with ventricular...

Verisante skin cancer detection system gainsHealth Canada approval
24 October 2011 Verisante Technology has secured a Health Canada licence for Verisante Aura, a non-invasive optical system designed to detect of skin cancers...

Jan Medical begins concussion system study
24 October 2011 Jan Medical has begun an outpatient clinical study to validate the Nautilus NeuroWave continuous brain-sensing system's ability to detect a unique 'signature' that strongly correlates with...

BioMimetic's Augment bone graft gains Australian aaproval
24 October 2011 Australia's Therapeutic Goods Administration has approved BioMimetic Therapeutics' Augment bone graft for marketing and listing on the Australian Register of Therapeutic...

First German patient completes treatment with Sapheon closure system
21 October 2011 Sapheon has treated its first patient with bilateral saphenous reflux in Germany using its Sapheon closure...

Spineology interbody fusion system wins FDA nod
21 October 2011 Spineology has received US Food and Drug Administration (FDA ) clearance for its new Rampart line of Interbody fusion...

CSI Predator 360 systems found to effectively treat PAD
21 October 2011 Cardiovascular Systems' (CSI) Predator 360° prospective single-centre clinical study has demonstrated beneficial long-term durability of the Predator 360 PAD system in treating peripheral...

InfraReDx LipiScan imaging system could detect LCPs associated with heart stroke
21 October 2011 InfraReDx has announced new data showing its LipiScan coronary imaging system can rapidly and accurately detect extensive lipid core plaques (LCPs) linked to an increased risk of heart...

Ventus Medical sleep apnea therapy shows positive results
20 October 2011 Ventus Medical has reported positive long-term clinical data from its proprietary Provent sleep apnea therapy, an innovative, non-invasive treatment for obstructive sleep apnea...

St. Jude Medical renal denervation technology to treat hypertension
20 October 2011 As part of a feasibility study, Royal Adelaide Hospital in South Australia has performed the first procedure using St. Jude Medical's renal denervation catheter and generator system to...

FDA clears Medtronic Aquamantys system for hemostatic sealing
20 October 2011 Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for its Aquamantys3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand...

OrSense hemoglobin monitor to detect hemorrhage in less time
20 October 2011 OrSense's non-invasive hemoglobin (Hb) measurement system, NBM 200MP, was found to monitor blood loss continuously and detect hemorrhages within...

EMKinetics commences neuromodulation system trial
19 October 2011 EMKinetics has begun the TranStim transdermal neuromodulation system trial in patients suffering from urge incontinence and overactive bladder....

FDA approves PLC Systems to begin RenalGuard trial
19 October 2011 The US Food and Drug Administration (FDA) has granted approval for PLC Systems to initiate its US pivotal trial to study the efficacy of the company's RenalGuard Therapy and RenalGuard System...

Paramit signs agreement to buy Lemtronics
19 October 2011 Medical device and instrument manufacturing services provider Paramit has entered into an agreement with Lemarne to purchase its Malaysian-based manufacturing organisation,...

Biodesix VeriStrat test could identify RCC disease characteristics
19 October 2011 Biodesix has reported that its pretreatment blood-based test, VeriStrat, was able to stratify renal cell carcinoma (RCC) patients treated with a combination of two targeted therapies,...

FDA approves Unisense FertiliTech EmbryoScope
18 October 2011 Unisense FertiliTech's EmbryoScope has received Food and Drug Administration (FDA) clearance for clinical use in...

Echo Therapeutics commences Symphony tCGM system trial
18 October 2011 Echo Therapeutics has initiated a clinical study of its Symphony transdermal continuous glucose monitoring (tCGM) system in patients with Type 1 and Type 2 diabetes....

Isto Technologies' bone graft substitute and extender wins CE mark
18 October 2011 Isto Technologies, an orthobiologics company, has received the Conformite Europeenne (CE) mark approval for its InQu bone graft substitute and...

PCF joins Exosome for biofluid molecular diagnostics technology clinical validation
18 October 2011 The Prostate Cancer Foundation (PCF) and Exosome Diagnostics have entered into a multiyear collaboration agreement to accelerate clinical validation of Exosome's biofluid molecular...

FDA clears CorMatrix carotid tissue repair implant
17 October 2011 CorMatrix Cardiovascular has received US Food and Drug Administration (FDA) 510(k) clearance for its CorMatrix ECM, a device designed for pericardial closure and carotid tissue repair...

Sanuwave's dermaPACE technology shows positive results
17 October 2011 Sanuwave Health's dermaPACE extracorporeal shockwave technology has demonstrated superiority over hyperbaric oxygen therapy in increasing angiogenic and tissue regenerative molecular changes...

BSD hyperthermia system found to benefit cancer patients
17 October 2011 BSD Medical has reported the positive study results of its BSD-2000 hyperthermia system, which is used to treat...

Northrop Grumman wins contract to develop human DNA identification system
17 October 2011 The US Army Biometrics Operations and Support Services - Unrestricted (BOSS-U) has awarded a contract to Northrop Grumman to further develop and supply IntegenX's RapidHIT 200 human...

Chembio syphilis assay obtains CE mark
14 October 2011 Chembio Diagnostics, which develops, manufactures, markets and licences point-of-care diagnostic tests, has received CE marking for its Dual Path Platform syphilis screen and confirm...

Innocoll surgical adhesion barrier wins European approval
14 October 2011 Innocoll has secured European approval for its CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic...

Cappella coronary sidebranch stent shows positive data
14 October 2011 Cappella Medical Devices has announced the initial long term follow up data for its Sideguard coronary sidebranch stent from Manchester Royal Infirmary in the...

EMA grants orphan drug status to OctreoPharm's SOMscan
14 October 2011 The European Medicines Agency (EMA) has granted orphan drug status to OctreoPharm Sciences' SOMscan, used for the diagnosis of gastro-entero-pancreatic neuroendocrine...

Cardiac treats first patient in Titan II study
13 October 2011 Cardiac Dimensions has treated the first patient in a clinical trial of its carillon mitral contour system, a novel therapy for treating heart failure patients suffering from functional...

Presbia Flexivue Microlens gets Israel registration approval
13 October 2011 Ophthalmic-device company Presbia has received medical device registration approval in Israel for its Flexivue Microlens solution for treating...

Japan approves Masimo pulse co-oximeter
13 October 2011 Masimo has received Japanese Ministry of Health Labor and Welfare regulatory clearance for its Rad-87 pulse co-oximeter with rainbow acoustic monitoring...

Bovie Medical to develop electrosurgical safety device
13 October 2011 Bovie Medical, a manufacturer and marketer of electrosurgical products, is set to develop a laparoscopic electrosurgical electrical leakage detection...

Medtronic reports positive ablation system trial results
12 October 2011 Medtronic has reported positive data from a trial of its Phased RF Ablation System for persistent atrial...

MagForce treats glioblastoma with NanoTherm therapy
12 October 2011 MagForce, a medical technology company focused on nanomedicine in oncology, has announced that it has treated a recurrent glioblastoma patient using NanoTherm...

NuVasive acquires US-based intra-operative monitoring provider
12 October 2011 NuVasive, a minimally disruptive surgical products maker, has acquired Impulse Monitoring, a US-based intra-operative monitoring...

Japan approves Vitrolife IVF treatment tools
12 October 2011 Vitrolife has secured Japanese regulatory approval for its aspiration needles and micro pipettes, which are used in IVF...

Novus reports pre-clinical data of TIGR surgical mesh
11 October 2011 Novus Scientific has reported the three-year pre-clinical data of the adsorbable TIGR matrix surgical mesh versus a permanent mesh in a sheep...

GE Healthcare 3T wide-bore MR system gets FDA clearance
11 October 2011 GE Healthcare has received US Food and Drug Administration (FDA) approval of the Discovery MR750w wide-bore 3T system with the Geometry Embracing Method (GEM) suite of...

St Jude Medical Penta surgical lead wins Japanese regulatory approval
11 October 2011 Japanese Ministry of Health, Labor and Welfare has approved St Jude Medicals' Penta surgical lead, designed for neurostimulation therapy to treat chronic...

Kerecis completes first human trial of lipid collagen matrix
11 October 2011 Kerecis, a manufacturer of tissue-regeneration materials, has completed the first human clinical trial of its MariGen Lipid Collagen...

Positive trial results for Brainsway deep TMS system
10 October 2011 Brainsway has reported additional interim results of a clinical trial being conducted at the Ichilov Medical Center in Israel to evaluate the efficacy of a deep transcranial magnetic...

FDA approves Ventana H. pylori antibody
10 October 2011 Ventana Medical Systems, a member of the Roche Group, has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Helicobacter pylori...

Bioness completes foot drop study enrolment phase
10 October 2011 Bioness has completed the initial enrolment phase of the FASTEST study to further examine the affect of its Ness L300 wireless neurostimulation technology on individuals with foot...

Carticept's Navigator DS gets FDA clearance
10 October 2011 The US Food and Drug Administration (FDA) has granted 510(k) approval for Carticept Medicals' Navigator Delivery System (Navigator DS) to treat cartilage injuries and...

Brainsway TMS device wins Israeli Ministry of Health approval
07 October 2011 Israel's Ministry of Health has approved Brainsway to market and sell the deep transcranial magnetic stimulation (TMS) device to four medical centres to treat neurological and...

Abbott enrols first patient in EXCEL trial
07 October 2011 Abbott has enrolled its first patient in the evaluation of XIENCE PRIME/XIENCE V versus coronary artery bypass surgery for the effectiveness of left main eervascularization (EXCEL)...

FDA, European commission clears Bioness wireless hand paralysis device
07 October 2011 Bioness has received US Food and Drug Administration (FDA) and CE mark approval for its NESS H200 wireless hand rehabilitation...

Illumina joins UNTHSC for forensic DNA analysis
07 October 2011 Illumina has entered into a collaborative research agreement with the Department of Forensic and Investigative Genetics and the Institute of Applied Genetics at the University of North Texas...

Siemens new mobile digital X-ray system wins FDA approval
06 October 2011 The US Food and Drug Administration (FDA) has approved Siemens Healthcare's Mobilett Mira, a mobile digital X-ray system with a wireless...

Vermillion PAD blood test shows positive results
06 October 2011 Vermillion, a molecular diagnostics company, has reported positive results from the intended use study for its peripheral artery disease (PAD) blood test,...

Expanding Orthopedics initiates XPED system post-market study
06 October 2011 Expanding Orthopedics, a medical device company developing innovative solutions for spinal care, has initiated a multicentre post-market study of its XPED Pedicle Screw for spinal fusion in...

GI Dynamics EndoBarrier found effective against diabetes, obesity
06 October 2011 GI Dynamics' EndoBarrier Gastrointestinal Liner has demonstrated blood sugar control and weight loss benefits beyond the implant period in the 12-Month Diabetes and Obesity...

Getinge to buy Atrium Medical
05 October 2011 Getinge, a global medical technology company with operations in the areas of surgery, intensive care, infection control, care ergonomics and wound care, has signed a binding agreement to...

JenaValve transapical TAVI system receives CE mark approval
05 October 2011 JenaValve Technology, a Germany-based medical device company, has received CE mark approval for its second-generation transapical transcatheter aortic valve implantation (TAVI) system, designed...

DARPA funds Aethlon to develop sepsis therapeutic device
05 October 2011 Defense Advanced Research Projects Agency (DARPA) has awarded a $6.8m contract to Aethlon Medical to develop a therapeutic device to reduce the incidence of...

FDA clears Nucletron new VCMC applicator for gynecologic cancers
05 October 2011 Nucletron, an Elekta company, has received US Food and Drug Administration (FDA) clearance for its new Vaginal CT/MR Multi Channel (VCMC) applicator, which enables very precise dose delivery...

Cardiac Dimensions wins CE mark approval for mitral contour system
04 October 2011 Cardiac Dimensions has received CE mark approval for its carillon mitral contour system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation...

Boston Scientific enrols first patient in NECTAR-HF trial
04 October 2011 Boston Scientific has completed first patient enrolment in a prospective randomised international neural cardiac therapy for heart failure (NECTAR-HF) clinical...

Atrium Advanta stent shows superiority against PAD
04 October 2011 Atrium Medical's covered versus balloon expandable stent trial (COBEST) demonstrated positive results of Atrium's proprietary balloon expandable covered stent technology over traditional bare...

FDA approves Roche diabetes test strip
04 October 2011 Roche has received US Food and Drug Administration (FDA) clearance for its Accu-Chek Aviva Plus test...

Calypso receives IDE approval for lung cancer study
03 October 2011 The US Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for Calypso Medical's clinical study evaluating Calypso systems' viability to precisely track...

NuVasive to purchase Impulse Monitoring
03 October 2011 NuVasive has accomplished a definitive agreement to acquire Impulse Monitoring, an intra-operative monitoring (IOM) provider in the United States for $80m, comprised of $40m in cash and $40m in...

FDA clears KCHC pediatric face mask
03 October 2011 Kimberly-Clark Health Care (KCHC) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its pediatric face mask....

Johnson & Johnson unit to acquire SterilMed
03 October 2011 Endo-Surgery, a Johnson & Johnson company, has signed a definitive agreement to acquire the US-based medical device repair company...

September 2011

Top

Aton acquires OrthoScan
30 September 2011 German private investment company Aton has acquired OrthoScan, an innovator in the orthopaedic imaging market that specialises in mini C-arm...

Boston bronchial thermoplasty system shows long-term efficacy results
30 September 2011 Boston Scientific has reported positive clinical data from a trial, demonstrating the long-term safety of bronchial thermoplasty in patients treated with the company's Alair bronchial...

FDA clears Titan Spine fixation device
30 September 2011 US-based medical implant surface technology company, Titan Spine, has received US Food and Drug Administration (FDA) clearance for its Endoskeleton TAS system, incorporating an ALIF device...

Medtronic commences Engager system trial
30 September 2011 Medtronic has initiated the pivotal trial to obtain CE mark approval for its Engager transcatheter aortic valve implantation system, used to treat patients suffering from severe aortic...

Given Imaging PillCam shows sensitivity against colorectal lesions
29 September 2011 Given Imaging has reported positive data from a prospective, blinded, multicentre study that investigated the sensitivity of PillCam Colon 2 video capsule for detecting clinically relevant...

FDA clears Zynex electrotherapy device
29 September 2011 Electrotherapy medical device maker Zynex has received US Food and Drug Administration (FDA) clearance for its NexWave...

Avinger Ocelot catheter receives CE mark
29 September 2011 Avinger has received the CE mark for its Ocelot catheter, designed to treat peripheral artery...

Aesculap acquires Aragon Surgical
29 September 2011 German-based surgical instruments and sterilisation container systems maker Aesculap has acquired the assets of Aragon...

Mela Sciences MelaFind PMA receives FDA approvable letter
28 September 2011 The US Food and Drug Administration (FDA) has issued an approvable letter to Mela Sciences for the MelaFind pre-market approval (PMA)...

Uptake Medical's InterVapor system gets CE mark
28 September 2011 Uptake Medical has received the CE mark for its InterVapor system, an endoscopic lung volume reduction system to treat severe...

Pulmonx pulmonary assessment system effectively treats emphysema
28 September 2011 Pulmonx has announced the final results of its Chartis multi-centre study confirming that the use of the Chartis pulmonary assessment system effectively treats...

OncoSec ElectroChemotherapy shows efficacy against cancer
28 September 2011 OncoSec Medical has presented positive results a Phase IV head and neck cancer trial, which has demonstrated that OMS ElectroChemotherapy is safe and...

IRIS prognostic cancer test secures FDA 510(k) clearance
27 September 2011 The US Food and Drug Administration (FDA) has granted 510(k) clearance for IRIS Internationals' Nucleic Acid Detection Immunoassay (NADiA) ProsVue prognostic cancer...

Sapheon gets CE mark for new varicose vein treatment
27 September 2011 Sapheon has received CE Mark approval for its new approach of treating varicose veins using the Sapheon Closure...

FDA urges epinephrine inhaler users to switch to replacement medication
27 September 2011 The US Food and Drug Administration (FDA) has said that users of epinephrine inhalers containing chlorofluorocarbons should switch to a replacement product, as these inhalers will not be made...

AirXpanders breast tissue expansion device shows efficacy
27 September 2011 AirXpanders has reported the positive results of Patient Activated Controlled Expansion (PACE) feasibility study investigating the AeroForm breast tissue expansion...

Stentys completes patient enrolment in APPOSITION III study
26 September 2011 Stentys has enrolled 500-patients in the APPOSITION III study for its self-apposing stent, used to treat acute myocardial...

Quidel human metapneumovirus assay receives CE mark
26 September 2011 Quidel, a provider of rapid diagnostic testing solutions and cell-based virology assays, has received the CE mark for its Quidel molecular RT-PCR assay for human...

Gynesonics commences study for the VizAblate system
26 September 2011 Gynesonics has begun a multicentre clinical trial to assess the effectiveness of the VizAblate system for the treatment of uterine fibroids associated with heavy menstrual...

FDA clears Toshiba M-Power interface
26 September 2011 Toshiba America Medical Systems' M-Power interface has received US Food and Drug Administration (FDA)...

FSS begins patient treatment with FlexStent system
23 September 2011 Flexible Stenting Solutions (FSS) has treated the first two patients in a clinical trial using the FlexStent Femoro popliteal self-expanding...

CardioKinetix secures financing to develop ventricular partitioning device
23 September 2011 CardioKinetix has raised $44m in Series E financing to progress the development of the Parachute ventricular partitioning...

Biotronik completes patient enrolment in BIOLUX P-I study
23 September 2011 Biotronik has completed patient enrolment in the BIOLUX P-I clinical study, which will investigate the use of a drug-eluting balloon catheter to treat peripheral artery...

Anulex fiXate Tissue Band gets FDA clearance
23 September 2011 Anulex Technologies has received US Food and Drug Administration (FDA) approval for its fiXate Tissue Band, designed to secure spinal cord stimulation lead anchors to the fascia or interspinous...

Varian Medical to acquire Calypso Medical Technologies
22 September 2011 Varian Medical Systems has signed a definitive agreement to acquire Calypso Medical Technologies, a privately owned developer and supplier of products and software for real-time tumour tracking...

Arbor Vita HPV biomarker test shows promise
22 September 2011 Arbor Vita's has announced positive interim clinical study results for its diagnostic human papillomavirus (HPV) E6 test for cervical cancer and precancerous...

Covidien reports positive results of stapling system
22 September 2011 Covidien has reported positive results from a trial of its first powered surgical stapling system, which offers deeper access, better visibility and easier placement inside the low pelvis than...

Nanosphere blood culture test demonstrates efficacy against bacterial targets
22 September 2011 Nanosphere's Verigene Gram-positive blood culture test has demonstrated 100% sensitivity and specificity for detection of drug-resistant bacteria MRSA and VRE, and an overall sensitivity of...

Ivantis reports positive Hydrus implant study results
21 September 2011 Ivantis has reported the six-month results from its multicentre, prospective and international Hydrus I study, which was designed to evaluate the safety and efficacy of the Hydrus...

Researchers develop new fluorescence-guided technology to detect tumours
21 September 2011 Surgeons at University of Groningen in the Netherlands have successfully performed the first fluorescence-guided surgery on an ovarian cancer patient using a cancer cell 'homing device' and...

Roche cobas HPV test shows promise in cervical cancer screening
21 September 2011 Roche's ATHENA study has demonstrated that human papillomavirus (HPV) DNA tests, including the Roche cobas HPV Test, provide an additional primary screening test for cervical...

New test for sleeping sickness
21 September 2011 Geneva-based not-for-profit foundation FIND and Japanese diagnostics company Eiken have developed a next-generation molecular test for sleeping...

DMC to begin sleep apnoea trial
20 September 2011 Detroit Medical Center has been selected to participate in a pivotal clinical study to evaluate the safety and effectiveness of Inspire upper airway stimulation therapy as a treatment for...

PediGuard shows efficacy in spine surgery
20 September 2011 SpineGuard has reported that its PediGuard platform has demonstrated a reduced incidence of clinically relevant misplaced screws during enhanced pedicle screw placement in its latest...

GI Dynamics' EndoBarrier shown to improve glycaemic control rate
20 September 2011 GI Dynamics' EndoBarrier gastrointestinal liner has demonstrated improvement in glycaemic control and weight loss as part of a trial. Seventeen obese patients with type 2 diabetes were...

Medtronic spinal system wins second FDA clearance
20 September 2011 Medtronic has received a second clearance from the US Food and Drug Administration (FDA) for its Texas Scottish Rite Hospital spinal system pedicle screw to treat adolescent idiopathic...

Zimmer spinal fixation system gets paediatric clearance
19 September 2011 Zimmer Holdings has received additional clearance for its proprietary Universal Clamp spinal fixation system, indicated for the treatment of idiopathic and neuromuscular scoliosis in patients...

Tests prove efficiency of chlorhexidine gluconate adhesive delivery system
19 September 2011 Avery Dennison Medical Solutions' chlorhexidine gluconate adhesive delivery system provides antimicrobial efficacy across a broad range of bacteria and yeast, according to tests conducted by...

US FDA approves Advanced Bionics cochlear implant for re-entry
19 September 2011 Advanced Bionics, a subsidiary of Switzerland-based Sonova, has received US Food and Drug Administration (FDA) approval for re-entry of its HiRes 90K cochlear implant in the US. The...

AxoGen reports Avance Nerve Graft study results
19 September 2011 A clinical study has demonstrated that AxoGen's Avance Nerve Graft is a safe method for reconstructing nerve discontinuities, with meaningful recovery achieved in 87.3% injuries. ...

Propel shows efficacy against chronic sinusitis
16 September 2011 Intersect ENT's prospective, randomised, controlled, double-blind, multicentre Advance II trial demonstrated that the Propel mometasone furoate implant improves outcomes for patients...

Baxano enrols first patient in STRiDE trial
16 September 2011 Baxano has completed the enrolment of the first patient in its post-market STRiDE (spondylolisthesis treated with an iO-Flex System enabled decompression) trial. The trial will enrol...

Solta to acquire Medicis Technologies
16 September 2011 Solta, a provider in the medical aesthetics market, has agreed to acquire all of the outstanding shares of Medicis Technologies, a subsidiary of US-based Medicis Pharmaceutical. Solta will...

FDA clears two Circa Scientific devices
16 September 2011 The US Food and Drug Administration has cleared Circa Scientific's Circa S-Cath and Circa Temperature Monitoring System. The S-Cath and temperature monitoring system address the...

Cytta deploys CyttaConnect medical monitoring system
15 September 2011 Cytta has completed the first patient implantation of its remote medical monitoring system, CyttaConnect. CyttaConnect delivers verifiable, real-time medical data transmission from...

Delcath presents oncology device trial results
15 September 2011 Delcath Systems has presented results from the metastatic neuroendocrine tumour cohort of a Phase II trial of its chemosaturation system. In the study, 24 patients with unresectable...

Integra to acquire Ascension Orthopedics
15 September 2011 Integra LifeSciences has signed an agreement to acquire Ascension Orthopedics for around $65m in cash, subject to adjustments. The acquisition will provide Integra with upper-extremity...

FDA clears IsoRay radiation therapy system
15 September 2011 The US Food and Drug Administration (FDA) has cleared IsoRay's GliaSite radiation therapy system, a balloon catheter device used in the treatment of brain cancer. The FDA clearance means...

Crescendo secures financing to develop diagnostic test
14 September 2011 Crescendo Bioscience has raised $56m in funding to develop and market a diagnostic test for inflammatory diseases. The funding includes $31m in series C equity financing and $25m of...

Trimega develops new test to diagnose foetal alcohol syndrome
14 September 2011 Trimega Laboratories has developed a new test to diagnose and analyse foetal alcohol syndrome in newborn babies in South Africa. Trimega's technology tests meconium, the first stool samples of...

HeartWare ventricular assist device completes GLP studies
14 September 2011 HeartWare's MVAD pump has achieved the objectives for system performance, haemocompatibility and biocompatibility in good laboratory practice (GLP) animal studies. The pump, a...

Siemens provides blood-gas analyser to GB Rowing Team
14 September 2011 Siemens has provided the GB Rowing Team with the RapidPoint blood-gas analyser to assist in training and improve performance. The blood-gas analyser enables the team to receive performance...

Vasomedical acquires Fast Growth Enterprises and Biox Instruments
13 September 2011 Vasomedical Global, a newly formed subsidiary of Vasomedical, has acquired Fast Growth Enterprises and Biox Instruments. The consideration of the acquisition includes a cash payment of $1m...

Jan Medical enrols first patient in cerebral vasospasm study
13 September 2011 Jan Medical has enrolled its first patient in a clinical study of the company's portable, continuous brain-sensing system to detect cerebral vasospasm. The study, to be conducted at...

Fluke Biomedical's ProSim simulators get FDA nod
13 September 2011 The US Food and Drug Administration (FDA) has granted 510(k) clearance to Fluke Biomedical's ProSim vital signs simulators for patient-monitor testing. The ProSim 8 all-in-one...

Concentric Medical concludes patient enrolment in Trevo trial
13 September 2011 Concentric Medical has completed patient enrolment in a study designed to assess the ability of the Trevo system to restore blood flow to the brain. Trevo system component Trevo...

Neoprobe receives guidance for RIGScan
12 September 2011 Neoprobe has received positive scientific guidance from the European Medicines Agency for the development of RIGScan CR, the company's proprietary radiopharmaceutical for the detection...

Nexera to submit amended antimicrobial claims for respiratory device
12 September 2011 Nexera Medical plans to submit new data to the US Food and Drug Administration to amend its current 510 clearance for the SpectraShield 9500 Surgical N95 Respirator with embedded...

St Jude neurostimulation device wins CE mark approval
12 September 2011 St Jude Medical has received European CE mark approval for its Genesis neurostimulation device for peripheral nerve stimulation of the occipital nerves associated with intractable chronic...

Croma partners with Ruck Tmed to develop ophthalmic surgical systems
12 September 2011 German-based speciality pharmaceutical and surgical company Croma Pharma and Ruck Tmed have entered into a partnership to develop and market a new generation of ophthalmology surgery...

CardioFocus reports HeartLight endoscopic ablation system trial results
09 September 2011 CardioFocus has reported one-year follow-up data from a trial of its HeartLight endoscopic ablation system as a treatment for atrial fibrillation. HeartLight consists of an...

US and Chinese universities partner to develop colorectal cancer diagnostics
09 September 2011 Arizona State University in the US and Sun Yat-Sen University in China are working together to develop early and predictive diagnostics to improve outcomes for patients with colorectal...

ResQCPR system shown to improve long-term brain function
09 September 2011 Advanced Circulatory Systems has reported that patients given new CPR devices have improved long-term brain function following cardiac arrest. A trial funded by the National Institutes of...

Hemosphere HeRO graft wins CE mark approval
09 September 2011 Hemosphere has received CE mark and ISO 13485 certification for the Haemodialysis Reliable Outflow (HeRO) graft, a vascular access graft for haemodialysis patients. HeRO graft is an...

U-Systems installs somo*v ABUS system in Canada
08 September 2011 U-Systems has completed the first Canadian installation of its somo*v automated breast ultrasound system at VIP Breast Imaging in Toronto, Canada. The device uses proprietary technology...

Aeris gets expanded EU approval for AeriSeal system
08 September 2011 Aeris Therapeutics has received expanded CE Mark approval in Europe for the AeriSeal System used to treat patients with emphysema. The move follows the availability of new clinical data from...

NeuroSigma receives grant for trigeminal nerve stimulation therapy development
08 September 2011 US-based NeuroSigma has received a notice of award for a $750,000 small business technology transfer Phase I grant from the National Institute of Neurological Disorders and Stroke. The...

Qiagen and Lilly to develop companion diagnostic test for JAK2 compound
08 September 2011 Dutch sample and assay technology provider Qiagen has partnered with Eli Lilly to develop, manufacture and commercialise a molecular companion diagnostic for Lilly's early-stage...

Phase II trial of chemosaturation system shows inconclusive efficacy
07 September 2011 Delcath Systems has reported top-line results from the metastatic colorectal (adenocarcinoma) cohort of a Phase II clinical trial of the Delcath chemosaturation system with melphalan in...

Medrad purchases Pathway Medical
07 September 2011 Medrad, a subsidiary of Bayer HealthCare, has purchased the assets of Pathway Medical Technologies. The acquisition allows Bayer HealthCare to strengthen its Medrad Interventional business...

ConvaTec acquires Boston Medical Device
07 September 2011 ConvaTec, a developer of medical technologies, has purchased all assets of Boston Medical Device. Boston Medical Device distributes specialised medical devices, and related healthcare...

EnteroMedics presents results of vagal blocking therapy trial
07 September 2011 EnteroMedics has presented data from the VBLOC-DM2 Enable trial evaluating effectiveness and safety of the company's second generation Maestro rechargeable system in the treatment of...

Medtronic purchases Peak Surgical and Salient Surgical
06 September 2011 Medtronic has acquired Peak Surgical and Salient Surgical Technologies to broaden its portfolio of surgical products. Salient's Aquamantys System uses patented Transcollation technology,...

Brainsway reports positive results from magnetic stimulation study
06 September 2011 Brainsway has presented preliminary efficacy results of a study exploring the efficacy of deep transcranial magnetic simulation in opening the blood-brain barrier in patients with brain tumours. ...

Stryker to acquire Concentric Medical
06 September 2011 Stryker has signed a definitive agreement to acquire US-based Concentric Medical for $135m. Concentric Medical develops, manufactures and markets minimally invasive products for the treatment...

Orthocon to develop Bezwada technology
06 September 2011 Orthocon, a manufacturer of products that stop bone bleeding, has entered into a worldwide licence agreement to develop and commercialise Bezwada Biomedical's technology for bone...

EMD Millipore acquires Amnis
05 September 2011 EMD Millipore, the Life Science division of Merck, has agreed to acquire Amnis, a US-based manufacturer of high-speed cell imaging systems. The acquisition will allow Amnis to expand its...

LaserGen raises funds to develop sequencing system
05 September 2011 LaserGen has raised $5m in series A financing to demonstrate accurate sequencing of the E. coli genome and to develop the company's next-generation sequencing system. The financing was led...

UK researchers say simple blood test can diagnose diabetes
05 September 2011 Researchers at Durham University and The James Cook University Hospital, both in the UK, have demonstrated that a simple finger prick test during routine eye examinations can help to...

Implantable oxygen generator developed to fight tumours
05 September 2011 Researchers from Purdue University and the Indiana University School of Medicine have developed and tested a miniature device that can be implanted in tumours to generate oxygen and enhance...

Metabolon completes series D financing
02 September 2011 Clinical diagnostics and services company Metabolon has secured $13.1m in series D financing to support further growth in the company's metabolytics division and the ongoing development of...

Unilife develops new range of auto-injectors
02 September 2011 US-based Unilife has developed a proprietary range of auto-injectors for the self-administration of injectable drugs outside of healthcare facilities. The auto-injectors are intended to be...

Mauna Kea endomicroscopy system wins FDA approval
02 September 2011 Mauna Kea Technologies has received US Food and Drug Administration (FDA) approval for its endomicroscopy system Cellvizio 100 Series to visualise and detect abnormalities in the...

Biotronik reports home monitoring system study results
02 September 2011 Biotronik's ECOST trial has demonstrated that its home monitoring system reduces inappropriate shocks and improves battery longevity in long-term follow-up of patients with an...

CoreValve system found effective for heart surgery
01 September 2011 Medtronic has presented the positive long-term study results of its CoreValve transcatheter aortic valve replacement system. The CoreValve system is designed to provide a minimally...

Qiagen acquires Cellestis
01 September 2011 Dutch sample and assay technology provider Qiagen has completed the acquisition of all ordinary shares in Cellestis. Upon completion of the transaction, Cellestis will become a...

FDA clears Toshiba's Kalare imaging system
01 September 2011 Toshiba America Medical Systems has received US Food and Drug Administration (FDA) approval for its Kalare HDR-08A imaging system. The system provides an intuitive user interface and...

Apollo reports first use of OverStitch system for colonic polyp resection
01 September 2011 Apollo Endosurgery has reported that surgeons at Vall d'Hebron University Hospital in Barcelona, Spain, have successfully performed a full-thickness resection of a colonic polyp using the...

August 2011

Top

Medtronic reaffirms information security commitment
31 August 2011 Following reports that its commercially available insulin pump is vulnerable to attacks, Medtronic has announced that device information security is an integral part of its product design process....

Israeli scientists develop new breast cancer scanner
31 August 2011 Israeli scientists have developed a new radiation-free scanner that can detect breast cancer more effectively than traditional X-ray mammograms. The machine detects tumours using infrared...

FDA approves Abbott gene test
31 August 2011 Abbott has received US Food and Drug Administration (FDA) approval for its Vysis ALK Break Apart FISH Probe test, which detects rearrangements of the anaplastic lymphoma kinase gene...

Biotronik reports home-monitoring study results
31 August 2011 Biotronik has reported the results of its Home Monitoring in Cardiac Resynchronisation Therapy clinical study. The international, multicentre, non-randomised and prospective study was...

ITM treats first patient in rhenium-PTA catheter trial
30 August 2011 ITM FlowMedical has treated the first patient in a clinical trial that compares ITM rhenium-PTA to a standard PTA for the treatment of peripheral artery occlusive disease. After a...

Thermo Fisher acquires Phadia
30 August 2011 Thermo Fisher Scientific has purchased all the assets of Phadia, a provider of blood tests for the clinical diagnosis and monitoring of allergies and autoimmune diseases. Phadia will become...

GeNO receives grant to develop Nitrosyl system
30 August 2011 GeNO has received a Phase I small business innovation research grant from US National Institutes of Health to develop its Nitrosyl system to treat multiple chronic pulmonary diseases. The...

FDA clears IQuum influenza A/B assay
30 August 2011 IQuum has received US Food and Drug Administration (FDA) clearance for its Liat influenza A/B assay and the Liat analyser. The Liat system integrates sample-volume metering, on-board...

Gen-Probe's Panther system receives Health Canada approval
26 August 2011 Gen-Probe has received Health Canada approval for its Panther system, an automated and integrated molecular testing system. The system will be used to run Gen-Probe's Aptima Combo 2 assay,...

Gore reports zero erosions with Helex septal occluder
26 August 2011 W L Gore & Associates has said that it has received no reports of erosion of the aortic root or the free wall of the atrium associated with the use of the Gore Helex septal occluder. ...

Aptiv Solutions acquires Medical Device Consultants
26 August 2011 Aptiv Solutions has completed the acquisition of Medical Device Consultants, a provider of expert medical device consulting and clinical trial management and execution. The acquisition adds...

NHGRI funds DNA sequencing technology development
26 August 2011 National Human Genome Research Institute (NHGRI) has granted Stratos Genomics $829,000 to develop DNA sequencing techniques using Expansion technology. Stratos will use the funds to...

Vention Medical buys Ansamed
25 August 2011 Vention Medical has acquired Ireland's Ansamed, a provider of advanced medical tubing solutions, including catheter design, development and manufacturing services. The acquisition will...

Abbott ophthalmic viscosurgical device wins CE mark approval
25 August 2011 Abbott has received CE mark approval for its Healon EndoCoat ophthalmic viscosurgical device for intraocular lens lubrication and insertion. The Healon EndoCoat delivery system includes...

Cleveland HeartLab completes series B financing
25 August 2011 Speciality clinical laboratory and disease management company Cleveland HeartLab has raised $18.4m in series B financing through Excel Venture Management and HealthCare Ventures. The funds...

Delcath reports top-line results of chemosaturation system
25 August 2011 Delcath Systems has reported encouraging top-line results from the hepatobiliary cohort of a Phase II clinical trial of its chemosaturation system with melphalan as a treatment of patients...

Medrad to acquire Pathway Medical Technologies
24 August 2011 Medrad, a unit of Bayer Healthcare, has reportedly agreed to acquire US-based Pathway Medical Technologies for $125m. Sources have told Xconomy that the transaction is still awaiting...

nContact EPi-Sense device receives CE mark
24 August 2011 nContact has received CE mark approval for its fourth generation EPi-Sense guided-coagulation device with VisiTrax for the treatment of cardiac arrhythmias, including atrial fibrillation. ...

US researchers receive grant to develop fall prediction and monitoring system
24 August 2011 Researchers at Virginia Tech and the University of Virginia have received a $1.2m grant from the National Science Foundation's Smart Health and Wellbeing Program to develop a portable...

Quanterix reports Crohn's study results
24 August 2011 Quanterix has reported the results of a pilot study to measure inflammation biomarkers in patients with Crohn's disease. The precise measurement of low-abundance cytokines, which was...

PositiveID completes Phase II glucose-sensing microchip testing
23 August 2011 PositiveID has successfully completed Phase II testing of its GlucoChip glucose-sensing microchip for patients with diabetes. GlucoChip is based on PositiveID's FDA-cleared microchip for...

Medtronic CoreValve system receives CE mark
23 August 2011 Medtronic has received CE mark approval for its 31mm Medtronic CoreValve System, which is designed to provide a minimally invasive treatment option for patients with symptomatic, severe...

BD and Biodiversity to develop assays for BD MAX system
23 August 2011 Becton, Dickinson and Company (BD) and Biodiversity have collaborated to develop and commercialise a comprehensive molecular diagnostic menu for immunocompromised patients on the BD MAX System. ...

Devicor acquires Neoprobe gamma detection devices
23 August 2011 GTCR portfolio company Devicor Medical Products has completed the acquisition of the neoprobe gamma detection system (GDS) products and related assets from Neoprobe for $30m in cash and...

U-Systems ultrasound device receives Health Canada approval
22 August 2011 U-Systems, a provider of automated breast ultrasound technology, has received the Health Canada approval for its Somo V Automated Breast Ultrasound (ABUS) system as an adjunct to mammography...

OrbusNeich presents Genous stent study results
22 August 2011 OrbusNeich has presented two years of follow-up data regarding the Genous stent. Genous, OrbusNeich's patented endothelial progenitor cell (EPC) capture technology, consists of an...

BD acquires Carmel Pharma
22 August 2011 Becton, Dickinson and Company (BD) has acquired Sweden-based Carmel Pharma, manufacturer of closed-system drug transfer device the PhaSeal System. The PhaSeal System is used for the...

Seattle Institute receives grant for newborn respiratory device
22 August 2011 Seattle Children's Research Institute, US, has received a two-year $2.3m grant from the Bill & Melinda Gates Foundation to complete prototype development of its new respiratory support device...

QSI to acquire CQI Solutions
19 August 2011 Quality Systems (QSI) has entered into an agreement to acquire Texas-based CQI Solutions. Upon acquisition, CQI will become part of QSI's wholly owned subsidiary NextGen Healthcare...

Spinal Restoration announces Biostat system study results
19 August 2011 Spinal Restoration has reported the final two-year outcome from a 15-patient FDA-regulated pilot study of its Biostat system. The Biostat system features a Biologx Fibrin sealant and...

Qiagen partners with Pfizer to develop companion diagnostic test
19 August 2011 Qiagen has entered into partnership with Pfizer for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound dacomitinib (PF-00299804), an...

FDA approves Intersect sinusitis implant
19 August 2011 The US Food and Drug Administration (FDA) has approved Intersect ENT's pre-market Approval (PMA) application for the Propel mometasone furoate implant, which offers localised, controlled...

Medtronic InterStim Therapy Improves Bowel Control, Study Reveals
18 August 2011 Medtronic has reported three-year safety and effectiveness data from a study of 120 patients who were given sacral nerve stimulation with implantable InterStim Therapy to treat chronic...

Prometheus and Medco Partner to Evaluate Thiopurine Metabolite Testing
18 August 2011 Prometheus Laboratories and the Medco Research Institute have announced that they will evaluate the use of Prometheus' thiopurine metabolite testing to optimise dosing of...

Seegene Presents Seeplex DV Assay Trial Results
18 August 2011 Seegene has reported positive results from a study that evaluated the Seeplex Diarrhea-V ACE (Seeplex DV) assay as a means of detecting diarrheal pathogens. Seeplex DV, a multiplex...

ArthroCare Knotless Fixation Device Wins FDA Clearance
18 August 2011 ArthroCare has received US Food and Drug Administration (FDA) approval for its SpeedLock knotless fixation device. SpeedLock, a push-in implant made of polyetheretherketone, provides...

FDA Clears IntriCon Cardiac Monitoring Device
17 August 2011 IntriCon has received US Food and Drug Administration (FDA) 510(k) marketing clearance for the Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring device. ...

New Urine Test to Help Diagnose Prostate Cancer
17 August 2011 Researchers at the University of Michigan Health System are investigating a Gen-Probe urine test to identify two genetic markers, TMPRSS2:EG and PCA3, that are known to be present in...

Crosstrees Pod Delivery Technology Awarded US Patent
17 August 2011 Crosstrees Medical's Pod delivery technology has been granted a patent from the US Copyright and Patent Office for use in vertebral fracture repair devices. Research and development staff...

US Researchers Develop Device to Monitor Nerve and Muscle Functions
17 August 2011 Researchers at the University of Illinois in the US have developed a device platform to monitor nerve and muscle activity that combines electronic components for sensing, medical...

MindFrame Reports Capture LP Device's First Implantation in Germany
16 August 2011 MindFrame's Capture LP low-profile device has been implanted in an ischaemic stroke patient at Katherinen Hospital in Stuttgart, Germany. Due to reduced microcatheter size, the MindFrame...

Ibis Biosciences Develops New Vector-Borne Pathogen Test
16 August 2011 Abbott subsidiary Ibis Biosciences has developed a new molecular assay to detect vector-borne microorganisms that are known to cause Lyme disease, Rocky Mountain spotted fever,...

Boston Scientific Stent Receives Canadian Approval
16 August 2011 Boston Scientific's WallFlex Biliary RX fully covered stent has received approval from Health Canada for the treatment of benign biliary strictures, which supplements its current indication...

New Blood Test to Analyse Foetal Sex
16 August 2011 Researchers have found that a new blood test can determine a baby's sex as early as seven weeks into pregnancy if used correctly. The non-invasive test analyses foetal DNA in the...

US Researchers Develop Biomarker Blood Test for Prostate Cancer
15 August 2011 Researchers at University of Cincinnati in the US have developed a DNA-based biomarker blood test to complement the prostate-specific antigen (PSA) test currently used to screen men for...

Abbott Receives FDA Clearance for Herculink Elite Renal Stent System
15 August 2011 Abbott has received US Food and Drug Administration (FDA) approval for the RX Herculink Elite renal stent system as a treatment for renal artery stenosis in patients with uncontrolled...

SHS Acquires Spiegelberg Shares
15 August 2011 Livingstone Partners' Healthcare sector team has advised the shareholders of Germany-based medical device maker Spiegelberg on the sale of its business to investor group SHS. ...

Medtronic Reports First Use of Symplicity Catheter System
15 August 2011 Medtronic has reported the first use of its minimally invasive Symplicity Catheter System to treat a patient with resistant hypertension at Clinica Santa Maria in Santiago, Chile. ...

US FDA Clears Toshiba 3T MR Imaging System
12 August 2011 The US Food and Drug Administration (FDA) has cleared Toshiba America Medical Systems' new Vantage Titan 3T open bore MR, which is designed to improve patient comfort and workflow. The...

Researchers Develop New Hormone Test to Predict Menopause
12 August 2011 Researchers at St Andrews University, Scotland, have developed a simple hormone test that could predict when a woman is likely to start the menopause. In collaboration with scientists...

SI-Bone Initiates Second Phase Study for iFuse Implant System
12 August 2011 SI-Bone has initiated a clinical study at high volume clinical sites in the US as part of its initiative to achieve clinical and economic evidence for its iFuse implant system. ...

CEMD and Leica Microsystems Collaborate to Develop FISH Kits
12 August 2011 China Medical Technologies (CMED) and Leica Microsystems division Leica Biosystems have formed a sales, research and development collaboration to co-develop and market automated FISH kits to...

Masimo Lifts Voluntary Recall on Pronto-7 Device
11 August 2011 Masimo has lifted the voluntary recall on the non-invasive finger sensor of its Pronto-7 handheld device. The palm-sized Pronto-7 measures hemoglobin, pulse oximeter oxygen saturation...

FDA Approves New GE Healthcare Imaging System
11 August 2011 GE Healthcare has received US Food and Drug Administration (FDA) clearance for its Optima CT660, a compact computed tomography (CT) system that offers enhanced diagnostic capabilities at low...

Ascendx Completes Mixed Financing for VCF Repair System
11 August 2011 Ascendx Spine has raised $4.8m in mixed financing to initiate commercialisation efforts for its vertebral compression fractures VCF Repair System. The mixed financing includes $1.7m in cash...

RapidArc Radiotherapy Effectively Treats Blood Cancer: Study
11 August 2011 Varian Medical Systems' RapidArc radiotherapy can treat patients with blood cancers quickly and accurately delivering clinically favorable total marrow irradiation (TMI), according to a study by...

NIH Funds ProTECT Trial to Study Biomarkers in TBI Patients
10 August 2011 The US National Institutes of Health (NIH) has awarded a five-year, $2.2m grant to researchers to study biomarkers in the blood of traumatic brain injury (TBI) patients. The research...

Antares Vibex MTX Injector Safely Delivers MTX in RA Patients
10 August 2011 Antares Pharma has reported positive results of a clinical study evaluating Vibex MTX, a proprietary auto injector designed to give a rapid subcutaneous injection of methotrexate (MTX) for...

Imris 3D Imaging Tool Receives Canadian Approval
10 August 2011 Imris has received a Health Canada medical device licence for its AccuTrack 3D image guidance tool, for use in Imris neurosurgery suites. The tool will enable surgeons to localise target...

Merge Healthcare Acquires Ophthalmic Imaging Systems
10 August 2011 Merge Healthcare has completed the acquisition of Ophthalmic Imaging Systems (OIS). The acquisition will add OIS ophthalmic imaging and informatics solutions, including a single...

Siemens Biograph mMR Receives Canadian Approval
09 August 2011 Siemens Canada Healthcare has received a Health Canada Medical Device Licence for its Biograph mMR. Biograph mMR offers simultaneous MR and positron emission tomography (PET) data acquisition....

Apnex Given Clearance for Obstructive Sleep Apnoea System Study
09 August 2011 Apnex Medical has received investigational device exemption approval from the US Food and Drug Administration to begin a clinical study of its hypoglossal nerve stimulation system in patients...

Vessix Vascular Completes Series B Financing
09 August 2011 Vessix Vascular has completed a $23m Series B preferred stock financing to accelerate product development initiatives and to conduct a series of multicentre clinical trials to further...

Covidien Commences Patient Enrolment in Anti-Restenosis Study
09 August 2011 Covidien has started patient enrolment in the ev3 definitive anti-restenosis study, designed to address the challenge of restenosis in patients with peripheral arterial disease. The study...

Trimega Labs Shortlisted for Orange Innovation Award
08 August 2011 UK-based substance abuse testing company Trimega Laboratories has been shortlisted for the Orange Innovation Award at the tenth annual National Business Awards. The company was...

Symmetry to Acquire Olsen Medical
08 August 2011 Symmetry Medical has signed a definitive agreement to acquire Olsen Medical's assets in an all-cash transaction. Olsen manufactures single-use and reusable bipolar and monopolar forceps,...

Becton Dickinson and Lab21 Partner to Develop Aspergillus Assay
08 August 2011 US-based Becton Dickinson Diagnostics has collaborated with Lab21 to develop a molecular diagnostic assay to detect the life-threatening Aspergillus fungus using its fully automated BD...

IMDx C. Difficile Assay Awarded CE Mark
08 August 2011 UK-based Intelligent Medical Devices (IMDx) has received CE mark approval for a high-throughput automated assay for the detection of C. difficile, including the A-B+ 1470 variant and the...

Intuity Medical Secures Financing For Glucose Monitoring System
05 August 2011 Intuity Medical has raised $76m in Series D Financing to obtain US Food and Drug Administration clearance of its Pogo all-in-one glucose monitoring system, and to prepare for the device's...

US Researchers Develop New High-Speed 3D Imaging System
05 August 2011 Researchers at Massachusetts Institute of Technology in the US have developed an imaging system that enables high-speed, 3D imaging of microscopic pre-cancerous changes in the oesophagus or colon....

Tornier Announces First Implant of Shoulder Joint Replacement System
05 August 2011 Tornier has announced that the first patient has been given its Simpliciti stemless shoulder joint replacement system as part of a investigational device exemption study in the US. The...

MindFrame LP Devices Win CE Mark
05 August 2011 MindFrame has received CE mark approval for its Capture LP and Flow LP devices, which are used to treat patients suffering from ischaemic stroke through microcatheter-based flow restoration...

CareFusion Acquires Rowa
04 August 2011 CareFusion has purchased German-based Rowa for approximately $150m. Rowa's core products enable high-density, high-speed storage and retrieval of a pre-packaged pharmaceutical inventory. ...

PathoGenetiX Completes Financing for Pathogen Identification System
04 August 2011 PathoGenetiX has received $4m in the first closing of series B financing to complete development of its pathogen identification system, which is based on genome sequence scanning (GSS) technology....

Pathwork Tissue of Origin Test Detects Metastatic Cancers
04 August 2011 Pathwork Diagnostics' tissue of origin test has demonstrated its capability to diagnose cancers such as those that are metastatic or have a complex clinical history. The test measures the...

FDA Approves Medtronic Advisa MRI System Trial
04 August 2011 The US Food and Drug Administration (FDA) has approved Medtronic's investigational device exemption (IDE) application to start the advisa DR MRI surescan pacing system clinical trial. ...

Infectious Disease Blood Test Shows Promise
03 August 2011 Researchers have tested a new portable blood test to detect HIV, syphilis and other infectious diseases. The new device – mChip –is about the size of a credit card and can diagnose...

AtCor and SunTech Establish Clinical Trials Data Management Agreement
03 August 2011 AtCor Medical and SunTech Medical have entered into an exclusive, multi-year clinical trials distribution and data management agreement. In addition to its SphygmoCor systems, AtCor will...

Prosthetic Knee System Offered to US Patients
03 August 2011 Prosthetic Orthotic Solutions International is offering Otto Bock Healthcare's Genium Bionic Prosthetic System to patients in Marlton, New Jersey, and Horsham, Pennsylvania. The Genium system,...

Mirador Pressure-Measurement Device Platform Receives CE Mark
03 August 2011 Mirador Biomedical has received the CE mark and ISO 13485 certification for its Compass pressure-measurement platform. Compass is a single-use, inexpensive, digital pressure-measurement...

Roche xCELLigence System to Quantify Cell Proliferation
02 August 2011 Researchers at the German Cancer Research Center in Heidelberg have used Roche's xCELLigence instrument to quantify human kinome RNAi in order to assay the effects of large numbers of...

VeraLight Scout DS Device Receives CE Mark
02 August 2011 VeraLight has received European CE mark approval for its Scout DS device for non-invasive diabetes screening. The device measures skin fluorescence using proprietary technology to...

HIV Combo Test Proven Effective
02 August 2011 Abbott's Architect HIV Ag/Ab combo assay, a combination antigen-antibody test, has been found to detect HIV infections earlier than antibody-only tests. The HIV Ag/Ab combo assay, the...

Histogenics Reports NeoCart Implant Study Results
02 August 2011 Regenerative medicine company Histogenics has announced positive results from a Phase II trial of its NeoCart Autologous Cartilage Tissue Implant for the treatment of knee cartilage...

Rheonix Device Could Diagnose Septicaemia
01 August 2011 Rheonix has announced the results of a study of SeptiCARD, a device to detect septicaemia in the blood. SeptiCARD uses a whole-blood sample for an accurate detection of bacteria in the blood. ...

Stryker Presents Aneurysm Coil Results
01 August 2011 Stryker Neurovascular, a division of Stryker Corporation, has presented the comparative study results of its Matrix Detachable Coils versus GDC Detachable Coils in the treatment of ruptured...

Covidien Embolisation Device Could Treat Uncoilable or Failed Aneurysms
01 August 2011 Covidien has announced that its Pipeline embolisation device has met the safety and efficacy endpoints of a study to assess its use in the treatment of uncoiled or failed aneurysms. The...

Vicor Signs Agreement with Zoll Medical
01 August 2011 Vicor Technologies has entered into a licensing and development agreement with Zoll Medical. The agreement allows Zoll to incorporate Vicor's patented, proprietary PD2i non-linear algorithm...

July 2011

Top

Ontario Officials Award Grant to Cancer Research Institute
29 July 2011 The Government of Ontario in Canada has awarded a five-year grant worth $420m to the Ontario Institute for Cancer Research to continue its research into the prevention, early detection,...

Micell Completes Patient Enrolment in Coronary Stent Study
29 July 2011 Micell Technologies has completed patient enrolment for the DESSOLVE II clinical study of its MiStent drug-eluting coronary stent system. MiStent is ultra-thin and is designed to...

OraSure to Acquire DNA Genotek
29 July 2011 OraSure Technologies is planning to acquire Canada-based DNA Genotek for approximately $53m in cash, subject to certain adjustments. The acquisition will strengthen OraSure's leadership in...

ArthroCare Suture System Receives FDA Clearance
29 July 2011 ArthroCare has received US Food and Drug Administration (FDA) approval for its SpeedFix Suture System. SpeedFix, a push-in anchor made of polyether-etherketone, is designed for the repair...

Lutonix Enrols First Patient in Levant 2 Study
28 July 2011 Lutonix has completed the enrolment of the first patient in the Levant 2 clinical trial, which will evaluate the safety and efficacy of the Moxy drug-coated balloon compared to a...

US Researchers Develop Artificial Lung
28 July 2011 Researchers at Case Western Reserve University, US, have developed an artificial lung that uses air as a ventilating gas instead of pure oxygen. The artificial lung was developed by...

Bio-Rad HIV Assay Receives US Pre-Market Application Approval
28 July 2011 Bio-Rad Laboratories has received pre-market application approval from the US Food and Drug Administration for its fourth-generation HIV assay, the GS HIV Combo Ag/Ab Enzyme Immunoassay. ...

Penumbra Initiates Stroke Trial
28 July 2011 Penumbra has initiated a randomised and concurrent controlled trial designed to prove the clinical benefits of its Penumbra system as an interventional treatment for acute ischaemic...

Medtronic Drug-Eluting Stent Proven Effective in Clinical Trial
27 July 2011 Medtronic's Resolute drug-eluting stent has been proven superior to Boston Scientific's Taxus drug-eluting stent in a clinical study in patients with coronary artery disease. The study...

EndoBarrier Gastrointestinal Liner Receives Australian Approval
27 July 2011 GI Dynamics has received Australian Therapeutic Goods Administration approval for its EndoBarrier Gastrointestinal Liner for the treatment of Type 2 diabetes and obesity. The EndoBarrier...

Roche to Provide Early Infant Diagnosis HIV/AIDS Tests
27 July 2011 Roche Diagnostics has been awarded a contract by National Health Laboratory Services in South Africa to support the Early Infant Diagnosis programme, which aims to identify HIV-infected...

Christie Radiotherapy Centre Installs Novalis System to Treat Cancer
27 July 2011 The Christie NHS Foundation Trust in England has installed the Novalis system, jointly developed by Varian Medical Systems and Brainlab, at its radiotherapy centre to treat cancer using...

Roche Colorectal Cancer Diagnostic Test Receives CE Mark
26 July 2011 Roche has received CE mark approval for its cobas KRAS mutation test for colorectal cancer. The cobas test identifies mutations in the KRAS gene of colorectal cancer tissues that are...

Breath Analyser Could Diagnose Breast Cancer at 'Stage 0'
26 July 2011 RNL Natural has developed a new method of detecting breast cancer as early as 'stage 0' through the presence of volatile organic compounds in patients' breath. Researchers at RNL conducted...

New Trial for Throat Cancer Test
26 July 2011 Cancer Research UK has initiated a large multicentre trial to determine whether a new device, the cytosponge, is effective at detecting Barrett's oesophagus, a precursor to throat cancer. ...

Canadian Heritage Fund Awards Grant for Cancer Research
26 July 2011 Northern Ontario Heritage Fund has granted $100,000 to Canada-based RNA Diagnostics to conduct further research into the development of a medical tool that assesses the effectiveness...

Malvern and Paraytec to Develop Imaging Technology
25 July 2011 UK-based Malvern Instruments has signed a development and licensing agreement with Paraytec, under which Paraytec will add its ActiPix technology to Malvern's materials characterisation portfolio....

National Institutes of Health Awards Grant to Mbio for Flu Test
25 July 2011 MBio Diagnostics has received a $5.2m grant from the US National Institutes of Health to detect respiratory pathogens in humans. The five-year Partnerships for Biodefence programme will...

Cutera Laser System Receives Canadian Approval
25 July 2011 US-based Cutera has received Health Canada approval for its GenesisPlus laser system as a treatment for onychomycosis (nail fungus), warts and scars. The laser system uses Cutera's...

Artegraft Bovine Carotid Artery Effective for Haemodialysis Access
25 July 2011 A three-year, prospective and randomised clinical study has demonstrated the superiority of Artegraft bovine carotid artery vascular grafts over cuffed ePTFE grafts for haemodialysis access. ...

nanoMR Completes Financing for Pathogen Capture System
22 July 2011 nanoMR has raised $13m in equity financing to develop commercial instruments for the clinical microbiology market, perform clinical studies and prepare for product launch. The proceeds...

ImaCor's ClariTEE Probe and Zura System Receive CE Mark
22 July 2011 ImaCor has received CE mark approval for its ClariTEE probe and Zura system. ClariTEE, a miniaturised TEE probe, is designed for haemodynamic assessment of high-acuity patients that can...

Sorin Group Acquires Estech Cannulae Portfolio
22 July 2011 Sorin Group has purchased Estech's cannulae portfolio, which supports minimally invasive and traditional cardiac surgery procedures, to meet current demands within its cardiac suite. ...

Roche to Acquire mtm laboratories
22 July 2011 Roche Diagnostics has signed an agreement to acquire mtm laboratories for an upfront payment of $180m. Roche will also pay $85m to mtm upon reaching performance-related milestones. Once...

OrbusNeich Presents Results of Genous Stent Study
21 July 2011 OrbusNeich's single-centre study of Genous endothelial progenitor cell-capture stent in patients with a high angiographic risk demonstrated good clinical and safety outcomes. The stent has...

Alphatec Receives Japanese Approval for Illico System
21 July 2011 Alphatec Spine has received Japanese regulatory Shonin approval for its Illico SE posterior fixation percutaneous screw system, for use in minimally invasive surgery. The Illico SE...

Bacterin Buys Robinson MedSurg Assets
21 July 2011 Bacterin International has acquired the assets of US-based medical device distribution company Robinson MedSurg for $1m. Bacterin acquired approximately $500,000 in inventory,...

IHD-Amy Blood Test Could Diagnose Alzheimer's
21 July 2011 Innovative Health Diagnostics has presented first results of its IHD-Amy blood test for Alzheimer's disease. The clinical study was carried out in partnership with Colmar Civil Hospitals on...

BioTime Receives Grant to Develop HyStem Microcarriers
20 July 2011 BioTime has been awarded a $335,900 small business innovation research grant from the National Institutes of Health to develop and test HyStem microcarriers in disease-relevant...

Non-Invasive Eye Test Could Reveal Alzheimer's
20 July 2011 Researchers at Australia's Commonwealth Scientific and Industrial Research Organisation believe that a simple eye test that detects differences in retinas can help in the early diagnosis...

Ellipse Presents Clinical Data of Scoliosis Device
20 July 2011 Ellipse Technologies has presented the preliminary clinical data of its non-invasive remote-controlled MAGEC system as a treatment for early-onset scoliosis in children. Ellipse claims...

St Jude's Ilumien System Receives CE Mark
20 July 2011 St Jude Medical has received the European CE mark approval for its Ilumien system, which is designed to improve the diagnosis and treatment of coronary artery disease. The system...

Biosense Enrols First Patient in SMART-AF Trial
19 July 2011 Biosense Webster, a Johnson & Johnson company, has enrolled the first patient in the SMART-AF investigational device exemption clinical trial of the Thermocool SmartTouch contact...

ActiViews CT-Guide System Approved in US
19 July 2011 The US Food and Drug Administration has cleared ActiViews' CT-Guide needle guidance system, which was developed to assist physicians during CT-guided interventional procedures. The system,...

Non-Invasive Breath Test Could Diagnose H1N1 Strain
19 July 2011 Researchers from Cleveland Clinic in Ohio, US, and New Zealand-based Syft Technologies have investigated an easy, non-invasive breath test to identify people infected with the H1N1 flu...

US Regulator to Unveil Medical Device ID Rule
19 July 2011 The US Food and Drug Administration is set to introduce a new rule that requires a unique identification system for medical devices in September 2011. Under the proposed rule, medical...

Vapotherm's Heliox Device Receives Canadian Approval
18 July 2011 Vapotherm has received approval for its Precision Flow Heliox device from the Medical Device Bureau of Health Canada. The device, part of Vapotherm's High Flow Specialty Gas Program, will...

US Researchers Begin CoreValve Device Study
18 July 2011 Researchers at Johns Hopkins University School of Medicine in the US have treated two Maryland patients with a new CoreValve device as part of a nationwide study. The CoreValve device...

InfraReDx Enrols First Patient in CANARY Trial
18 July 2011 InfraReDx has enrolled the first patient in a Phase II clinical trial of its LipiScan intravascular ultrasound system, a multimodality coronary imaging device. LipiScan, which...

Biotronik Begins Bioflow-II Study
18 July 2011 Biotronik has initiated an international study - Bioflow-II - to compare its Orsiro sirolimus-eluting coronary stent with Abbott’s Xience Prime everolimus-eluting coronary stent in Europe. ...

Exact Sciences Initiates Patient Enrolment in Colorectal Cancer Screening Trial
15 July 2011 Exact Sciences has initiated patient enrolment for the pivotal trial of its multi-marker molecular diagnostic screening test for the early detection of colorectal cancer. The multicentre...

Boston Completes Patient Enrolment in ASTI Study
15 July 2011 Boston Scientific has completed patient enrolment in the ASTI study of its Adapt Monorail carotid stent system for the treatment of carotid artery disease. The stent features thin struts...

Sanuwave Announces 24-Week Data from Diabetic Foot Ulcers Trial
15 July 2011 Sanuwave Health has presented positive results from a Phase III clinical trial designed to quantify the safety and efficacy of four 20-minute, non-invasive procedures with dermaPACE as a...

Sequana Receives CE Mark for ALFApump System
15 July 2011 Sequana Medical has received the CE mark for its ALFApump System, a proprietary implantable pump system designed to remove excess abdominal fluid (ascites) in patients suffering from...

Calmare Pain Therapy Device Receives Korean Approval
14 July 2011 Competitive Technologies has received Korea Food and Drug Administration approval for its non-invasive Calmare pain therapy device. Calmare is indicated to treat patients...

US Study Demonstrates Pathwork Tissue of Origin Test Efficacy
14 July 2011 Researchers at the University of California San Francisco have conducted a study to demonstrate the accuracy of Pathwork Diagnostics' Tissue of Origin Test in diagnosing cancers. The Tissue...

IlluminOss Bone Stabilisation System Used to Treat Osteoporotic Fracture
14 July 2011 IlluminOss Medical has announced the first implant of its photodynamic bone stabilisation system to repair and stabilise a fibula fracture in an 80-year-old woman at the Paracelsus Klinik...

US Approves St Jude Deep Brain Stimulation Study Expansion
14 July 2011 St Jude Medical has received US Food and Drug Administration approval to expand the BROADEN study of the Libra deep brain stimulation system for depression. With this approval, St.Jude can...

Medtronic to Buy Peak Surgical
13 July 2011 Medtronic has entered into a definitive agreement to acquire Peak Surgical for $120m. It has previously invested in Peak Surgical and currently holds an ownership stake in the company. Net...

US Researchers Develop High-Resolution Imaging Technology
13 July 2011 Researchers at the Wellman Center for Photomedicine at Massachusetts General Hospital in the US have developed an optical coherence tomography with a 1µm-resolution that can reveal...

Japan Approves Cardiac Science's Powerheart G3 Automated External Defibrillator
13 July 2011 Japan's Ministry of Health, Labour, and Welfare has approved Cardiac Science's new model of Powerheart G3 automated external defibrillator. The company is partnering with Japan-based...

Qiagen to Acquire Stake in Ipsogen
13 July 2011 Qiagen has entered into binding agreements to purchase a 61% stake in Ipsogen for €12.90 ($18.29) per share. The acquisition will provide Qiagen with access to a broad range of...

Medtronic to Acquire Salient Surgical Technologies
12 July 2011 Medtronic has agreed to acquire medical technology company Salient Surgical Technologies for $525m. The firm currently holds an ownership stake in the company. Net of this stake,...

New Assay to Detect Lung Cancer
12 July 2011 Researchers at the University of Chile's Center for Cancer Technologies have found that Radient Pharmaceuticals' Onko-Sure DR70 assay can effectively detect early lung cancer. In a...

Intra-Operative Ultrasound Found Effective for Hepatic Cancer
12 July 2011 ALOKA Holding Europe has announced a collaboration with the University of Milan's School of Medicine Surgery to explore the clinical benefits of intra-operative ultrasound in hepatic cancer cases....

ThromboView Found to be Well-Tolerated by Patients
12 July 2011 Agenix has reported the results of a study that evaluated the safety and efficacy of its ThromboView diagnostic test in patients with suspected acute pulmonary embolism. The 52...

Laser Raman Spectroscopy System Detects Lung Cancer
11 July 2011 Verisante Technology has announced positive results from a pilot study of a laser Raman spectroscopy prototype to detect lung cancer. The Verisante Core system reduced lung cancer...

Zebrafish Embryo Could Detect Medical Device Toxicity
11 July 2011 A fast-track test that uses zebrafish embryos could help scientists screen plastics and polymers in medical devices for toxicity. A study conducted by Microtest Laboratories found that the...

Radiofrequency Augmentation Therapy Treats Vertebral Compression Fractures
11 July 2011 DFINE has announced beneficial results from a study demonstrating the ability of radiofrequency-targeted vertebral augmentation (RF-TVA) with the StabiliT system in the treatment of...

Endosense and GE Healthcare Sign Joint Development Agreement
11 July 2011 Endosense and GE Healthcare have entered into a joint development agreement to integrate the contact-force data provided by Endosense into GE's CardioLab electrophysiology recording and...

Prototype Device Could Help Doctors Prescribe Appropriate Medication
08 July 2011 Scientists at Imperial College London in the UK have successfully tested a prototype handheld device designed by DNA Electronics to determine whether patients are genetically predisposed...

CareFusion to Acquire Rowa
08 July 2011 CareFusion has signed an agreement to acquire Germany-based Rowa for approximately $150m. The acquisition is expected to accelerate growth of CareFusion Pyxis dispensing technologies into...

Researchers Develop Robotic Endoscopy Surgery to Treat Gastric Tumours
08 July 2011 Researchers at Nanyang Technological University and National University Hospital in Singapore have developed a new technology to treat gastric tumours. The master and slave...

US Researchers Say PACE Technology is Effective for Ischaemia
08 July 2011 Researchers at Cleveland Clinic in the US have presented positive results from a study of Pulsed Acoustic Cellular Expression (PACE) technology, used for the treatment of ischaemic tissues. ...

Merck Receives European Approval for Pre-Filled Pen Injectors
07 July 2011 Merck Serono has received European Commission approval for three pre-filled, ready-to-use pen injectors for fertility treatment. The pen injectors are designed for self-administration of...

SQI Diagnostics to Buy Scienion
07 July 2011 SQI Diagnostics has entered into an agreement to acquire all of Scienion's share capital for CDN$15m (US$15.63m) in cash and the issuance of 735,294 common shares in the capital of SQI. ...

Pocket Ultrasound Could Reduce Costs and Improve Care
07 July 2011 Research conducted by the Scripps Translational Science Institute and Scripps Health has proved that General Electric's Vscan pocket ultrasound device, used for point-of-care assessment of...

MedMira to Develop Rapid Hepatitis B Test
07 July 2011 MedMira has been awarded a $2.3m contract by the US Army Medical Research Acquisition Activity to develop and commercialise a multi-marker rapid test for the detection of the Hepatitis B core...

Auxogyn Initiates Clinical Study of Embryo Assessment System
06 July 2011 Auxogyn has initiated a multicentre clinical study of its non-invasive early embryo viability assessment system, which is used during IVF treatment. The system is designed to help...

Sonitus SoundBite Hearing System Receives Additional FDA Clearance
06 July 2011 Sonitus Medical has received the second US Food and Administration (FDA) approval for its SoundBite hearing system. The hearing system is a non-surgical and removable hearing solution...

US Scientists Develop Personal Dosimeter to Measure Radiation Exposure
06 July 2011 The US Department of Homeland Security's Science and Technology Directorate has developed a miniature dosimeter, a portable device to measure ionising radiation exposure. The device is...

Ansell Acquires Sandel Medical Industries
06 July 2011 Ansell has acquired Sandel Medical Industries, an innovator in surgical safety solutions, for $13.5m. The purchase agreement includes sales and growth-based earn-outs over the next five years. ...

US Medical Facility Conducts Study of New Technology for Insomnia
05 July 2011 Wake Forest Baptist Medical Center in the US is conducting the first randomised and controlled clinical study using Brainwave Optimisation to treat insomnia, a sleep disorder. ...

Xlumena Receives CE Mark for NAVIX Access Device
05 July 2011 Xlumena has received the CE mark for its NAVIX Access Device, which enables exchange-free access, tract dilation and guidewire delivery during endoscopic pancreatic pseudocyst drainage. ...

US Surgeon Implants Pacemaker-Like Device for Bowel Incontinence
05 July 2011 A surgeon at the University of Rochester Medical Center in the US has become the first in the country to implant a pacemaker-like device that could help people with faecal incontinence regain...

Aegea to Develop Endometrial Ablation System
05 July 2011 Aegea Medical has raised $13.3m from Covidien Ventures, Alloy Ventures and Delphi Ventures to complete the development and clinical testing of its endometrial ablation system. The...

CardioFocus Endoscopic Ablation System Proven Effective for Atrial Fibrillation
04 July 2011 CardioFocus has announced successful results from a study of the HeartLight endoscopic ablation system, which is used for the treatment of atrial fibrillation, at the European Heart...

NEC Medical Diagnostic Monitor Receives FDA Clearance
04 July 2011 US monitor designer NEC Display Solutions has received US Food and Drug Administration (FDA) approval for its 30in MultiSync MD301C4 medical diagnostic display, used for displaying and...

US Students Invent Device to Reduce Dialysis Risks
04 July 2011 Graduate students at Johns Hopkins University in the US have designed a device to reduce the risks of infection, clotting and narrowing of the blood vessels in kidney failure patients who...

Canadian Researchers Develop Drug Delivery Device
04 July 2011 Researchers at the University of British Columbia in Canada have developed an implantable drug delivery device to treat retinal damage caused by diabetes. The device, implanted behind the...

New Hybrid Procedure to Treat Atrial Fibrillation
01 July 2011 Doctors at Washington University School of Medicine in Missouri, US, are performing a new hybrid procedure using minimally invasive surgical techniques and catheter ablation to treat...

Radiofrequency Ablation Therapy Could Treat Spinal Tumours
01 July 2011 DFINE has announced the successful clinical results of the first patient treatment using the Spinal Tumor Ablation with Radiofrequency (STAR) system, used to treat painful metastatic...

UK Researchers Identify E Coli Proteome Using Orbitrap Technology
01 July 2011 Researchers at the UK's Health Protection Agency have identified the proteome of the organism responsible for the recent E. coli outbreak in Europe using Thermo Scientific LTQ Orbitrap...

Left Ventricular Assist Device Therapy Proven Effective in Older Patients
01 July 2011 Sharp Memorial Hospital in California, US, has reported positive results from a study of left ventricular assist device therapy in patients with heart failure aged 70 or older. The...

June 2011

Top

Biotronic Completes Patient Enrolment in 4EVER Clinical Study
30 June 2011 Biotronic has successfully completed the enrolment of 120 patients into the physician-initiated 4EVER clinical study of Astron Pulsar and Pulsar-18 stents. The prospective,...

US University Develops New Software for Brain Scan Research
30 June 2011 Researchers at University of Colorado Boulder in the US have developed software that will allow neuroscientists to archive and retrieve brain images from hundreds of individual studies. ...

Arch Biopartners and Canadian Research Council to Develop BTIC Diagnostic Imaging Agents
30 June 2011 Arch Biopartners and its subsidiary Arch Cancer Therapeutics have entered into an agreement with the National Research Council of Canada to develop prototype brain tumour initiating cell...

Ivantis Receives Funds for Hydrus Device Clinical Study
30 June 2011 Ivantis has received $17m from New Enterprise Associates and Delphi Ventures to expand clinical activities for its CE-marked Hydrus device, used for the treatment of primary open-angle glaucoma. ...

ATI Reports Positive Study Results of Neurostimulation System
29 June 2011 Autonomic Technologies (ATI) has announced positive preliminary results from a study evaluating the safety and efficacy of its neurostimulation system for the treatment of cluster headaches. ...

ArtVentive's EOS Device Proven Effective for Vessel Occlusion
29 June 2011 ArtVentive Medical Group has conducted first human clinical study of its EOS peripheral vascular occlusion device. EOS is a catheter-based, self-expandable device used to achieve permanent...

Space Research Could Lead to New Cancer Treatment
29 June 2011 Astronomers at Ohio State University in the US are working with medical physicists and radiation oncologists to develop a new radiation treatment for cancer. They discovered that heavy...

Non-Invasive Ultrasound Treatment Could Heal Broken Bones
29 June 2011 A non-invasive treatment option is available to heal bone fractures without the need for surgery. The battery-powered Exogen Ultrasound Bone Healing System emits low-intensity soundwaves...

Saliva Test Can Predict Age
28 June 2011 Researchers at University of California Los Angeles in the US have developed a saliva test to determine a person's age and predict age-related diseases. Dr Eric Vilain and his colleagues...

Non-Invasive Breath Test Could Detect Vitamin B12 Deficiency
28 June 2011 Researchers from Metabolic Solutions and the University of Florida in Gainesville, US, have developed a simple, non-invasive and low-cost breath test to measure vitamin B12 levels. Vitamin...

Researchers Say Proton Beam Therapy Can Control Breast Cancer
28 June 2011 Researchers at Loma Linda University Medical Center in the US have reported successful Phase II clinical trial results of proton beam therapy, used to control breast cancer with minimal...

GE Healthcare Mobile X-Ray Systems Receive FDA Clearance
28 June 2011 GE Healthcare has received US Food and Drug Administration (FDA) approval for three mobile X-ray systems. The Optima XR220amx, Optima XR200amx and Brivo XR285amx have touchscreens and...

MiMedx Receives FDA Clearance for HydroFix Ortho Shield
27 June 2011 MiMedx Group has received US Food and Drug Administration (FDA) approval for its HydroFix Ortho Shield device, used for the management and protection of tendon injuries. The HydroFix...

Australia and New Zealand to Form Joint Medical Devices Regulatory Body
27 June 2011 Australia and New Zealand have announced plans to establish a joint regulatory body for medical devices. A five-year plan has been proposed to form the Australia New Zealand Therapeutic...

US Firm Develops New Fluid Evacuation Pad
27 June 2011 US-based O R Innovation has developed a pad to absorb fluids that flow off of operating room tables. The Remora fluid evacuation pad can absorb 3.7l of a minute, helping to speed...

Dentsply to Acquire Astra Tech for $1.8bn
27 June 2011 Dentsply International has signed a definitive agreement to acquire AstraZeneca dental implants and medical devices unit Astra Tech for $1.8bn in cash. The deal will increase Dentsply's...

Researchers Reveal Spinal Proteins That Could Predict Alzheimer's
24 June 2011 Researchers at the Technical University of Munich in Germany have trialled a spinal fluid test in patients with mild cognitive impairment. The study involved analysis of a number of spinal...

Japanese Researchers Develop Remote-Control Endoscope
24 June 2011 Japanese researchers have developed a self-propelled and remote-controlled capsule endoscope to image the stomach and colon. The tadpole-shaped capsule of the Mermaid endoscope is about 1cm...

Philips Acquires AllParts Medical
24 June 2011 Royal Philips Electronics has acquired AllParts Medical so that it can supply the imaging market with service parts, training programmes and technical support. Philips Healthcare...

BSD Presents Results of Microwave Ablation System
24 June 2011 BSD Medical has presented the beneficial results of the MicroThermX Microwave Ablation System at the World Conference on Interventional Oncology in New York City, US. The microwave...

US University to Develop 3D Neural Probe for Tinnitus
23 June 2011 National Science Foundation has awarded $330,000 to Wayne State University in Michigan, US, to develop a 3D neural probe to suppress tinnitus, a hearing disorder. Researchers aim to...

MedShape Develops New Versions of its Interference Fixation Device
23 June 2011 MedShape Solutions has developed several larger versions of it ExoShape CL, a two-part PEEK Altera interference fixation device. The device simplifies and improves soft tissue graft...

National Institutes of Health Awards Grant for Bartonella Test Development
23 June 2011 The National Institute for Allergies and Infectious Disease at the US National Institutes of Health has awarded a grant of $188,000 to Galaxy Diagnostics to further develop its Bartonella test. ...

X-spine Interspinous Fusion System Receives CE Mark
23 June 2011 X-spine has received the CE mark for its AXLE interspinous fusion system, which is designed to provide spinal stability for the treatment of degenerative disk disease, spinal tumours and trauma. ...

London Surgeon Develops New Spinal Fixator
22 June 2011 Orthopaedic surgeon Dr Seyed Rezaian has invented a new spinal fixator to help restore proper spinal function. The Rezaian Spinal Fixator is used to replace the broken vertebrae, creating...

Myoguide Injection Site Targeting System Receives CE Mark
22 June 2011 Intronix Technologies has received the CE mark for its Myoguide injection site targeting system, which is used to treat patients suffering from acute and chronic pain or spasticity. The...

New Brain Implant Shown to Improve Memory in Rats
22 June 2011 Scientists at Wake Forest University in North Carolina, US, have designed a brain implant shown to restore lost memory function and strengthen new information recall in laboratory rats. ...

Optical Microchip Technology Detects Foot and Mouth Disease
22 June 2011 Stratophase has demonstrated the feasibility of a transportable foot and mouth disease detection unit that uses company's proprietary optical microchip technology. The sample is mixed with...

Non-Invasive Brain Implant Could Treat Paralysis
21 June 2011 Researchers at the University of Michigan in the US have developed a brain implant to reactivate paralysed limbs. The BioBolt implant consists of a thumbnail-sized film of microcircuits that...

Medtronic Thoracic Stent Graft System Successful in Trial
21 June 2011 Medtronic has reported positive results from the VALOR II study of its Valiant thoracic stent graft system, used to treat thoracic aortic aneurysms. The 12-month, prospective, single-arm...

Cerbomed Vagus Nerve Stimulation Device Shows Promise for Epilepsy
21 June 2011 Cerbomed transcutaneous vagus nerve stimulation device NEMOS could be used to treat epilepsy, a study conducted in Germany has revealed. The device achieved decrease in the frequency...

Foetal ECG Detects Acidosis
21 June 2011 Researchers at the University of Granada in Spain have reported that foetal ECG is more effective than pulse oximetry for detecting acidosis. The finding is based on a prospective...

Continence Control Device Shows Efficacy in Colostomy Patients
20 June 2011 ConvaTec has reported successful results from a Phase III study of the Vitala continence control device in colostomy patients. The multicentre trial evaluated the safety and efficacy of...

UK MoD Subsidiary Files Lawsuit Against 3M Over MRSA Test
20 June 2011 A subsidiary of the UK Ministry of Defence (MoD) has filed a lawsuit against US firm 3M, claiming that it failed to properly market innovative MRSA diagnostic test BacLite. The...

Neogenix and Cambridge Biomedical to Develop ELISA Assay
20 June 2011 Neogenix Oncology has entered into an agreement with Cambridge Biomedical to develop its pancreatic and colorectal cancer diagnostic serum ELISA assay. The ELISA assay will use the...

Salient Receives FDA Clearance for Aquamantys Bipolar Sealer
20 June 2011 Salient Surgical has received US Food and Drug Administration (FDA) clearance for its Aquamantys bipolar sealer for use in blunt dissections. The disposable sealer is comprised of...

Non-Invasive Liver Tests Could Predict Survival in Hepatitis C Patients
17 June 2011 A study has revealed that non-invasive tests for liver fibrosis could predict the survival of patients with chronic hepatitis C. The research, published in medical journal...

Tissue of Origin Test Given Medicare Coverage
17 June 2011 Pathwork Diagnostics has announced that its Tissue of Origin Test, which helps identify the primary tumour in difficult-to-diagnose cancer cases, is now covered by Medicare. The test has...

DePuy Ceramic-on-Metal Hip Replacement Receives FDA Approval
17 June 2011 DePuy Orthopaedics has received US Food and Drug Administration (FDA) approval for its ceramic-on-metal total artificial hip system for patients with osteoarthritis. The Pinnacle...

Scientists Develop Cooling Cap to Treat Insomnia
17 June 2011 US researchers have developed a 'nightcap' filled with tubes of chilled water to treat insomnia. The cap works by cooling the brain's pre-frontal cortex, which lies just below the...

Trial of Health Monitoring Device for Heart Disease Continues
16 June 2011 HP, SingTel, HealthSTATS and Frontier Healthcare are collaborating on an eight-week clinical trial of a mobile health monitoring solution for heart disease. The solution wirelessly...

Saliva Test Developed for Scoliosis Diagnosis
16 June 2011 Axial Biotech has developed a simple saliva test to diagnose mild adolescent idiopathic scoliosis in Caucasian children between the ages of nine and 13. The Scoliscore test test, the...

Hamilton and Isee3D to Develop Microscope Technology
16 June 2011 Hamilton Thorne has partnered with Isee3D to develop unique single camera, single lens, single-chip, 3D microscope technology for stem cell research. The microscope technology is an adapter...

Scientists Develop Portable System to Diagnose Cancer
16 June 2011 Scientists at Harvard Medical School and Massachusetts General Hospital, both in the US, have developed a new portable nuclear magnetic resonance (micro-NMR) system to diagnose cancer in less...

New Computational Tool to Detect Cancer-Causing Genes
15 June 2011 Scientists from St Jude Children's Research Hospital and the Washington University Paediatric Cancer Genome Project have developed a new computational method to identify the genetic missteps...

US Researchers Develop Pulseless Heart
15 June 2011 Researchers at Texas Heart Institute in Texas, US, have developed a ventricular assist device that doesn't produce a heartbeat. A device uses a rotor of blades to push blood forward in...

New Closed-Loop Artificial Pancreas Developed
15 June 2011 Researchers at Rensselaer Polytechnic Institute in the US have developed a closed-loop artificial pancreas to for use in patients with type 1 diabetes. The device consists of an insulin...

Siemens Biograph mMR Receives FDA Clearance
15 June 2011 Siemens Healthcare has received US Food and Drug Administration (FDA) clearance for its Biograph mMR. The Biograph mMR is the first system to enable simultaneous whole-body data acquisition...

New Imaging Method Developed for Cardiovascular Disease Diagnosis
14 June 2011 Researchers from Indiana University School of Medicine and Purdue University have developed a new type of imaging technology to diagnose cardiovascular disease. The technique uses...

Leishmaniasis Assay Receives FDA Clearance
14 June 2011 The US Food and Drug Administration (FDA) has approved the Smart Leish polymerase chain reaction assay to diagnose individuals with cutaneous leishmaniasis caused by sand flies. The assay...

Sunshine Completes Initial Study of Heart Assist System
14 June 2011 Sunshine Heart has completed an initial animal study of the transcutaneous C-Pulse heart assist system, used to relieve the symptoms of heart failure. The study, conducted at Texas...

Extracorporeal Shockwave Therapy Effective for Osteoarthritis Damage
14 June 2011 SANUWAVE Health has reported the results of a study that examined the use of extracorporeal shockwave therapy to prevent and repair osteoarthritis damage. The study involved an animal...

Pocket Guide for Mild Traumatic Brain Injuries Launched in US
13 June 2011 The US Department of Defense has unveiled a new mobile application, the Mild Traumatic Brain Injury Pocket Guide. Developed by the National Center for Telehealth and Technology, the...

In-Home Health Monitoring Available for Windows 7 Devices
13 June 2011 The Intel-GE Care Innovations Guide, which provides in-home virtual care coordination, is now available on hundreds of Windows 7 devices. The guide will allow care providers to...

Tempasure Cardiac Ablation Catheter Receives CE Mark
13 June 2011 Advanced Cardiac Therapeutics has received the CE mark for its Tempasure cardiac ablation catheter, used for treating atrial arrhythmias. The catheter system, based on sensing...

PhotoMedex Develops Laser to Treat Psoriasis in Children
13 June 2011 PhotoMedex has developed a laser treatment for psoriasis in children. The Xtrac Excimer Laser can be used to focus a beam of UVB light on the affected area without exposing healthy skin. ...

UK Hospital Performs Pioneering Asthma Treatment
10 June 2011 Doctors at the University Hospital of South Manchester in the UK have carried out the first endoscopic procedure using radio waves to help asthma patients breathe easier. The new...

Arteriocyte and US Army to Develop Cellular Therapies for Orthopaedic Trauma
10 June 2011 Arteriocyte has entered into a cooperative research and development agreement with the US Army Institute of Surgical Research. The colloboration involves the investigation of new stem...

Magnetic Fields Found to Reduce Blood Viscosity
10 June 2011 Researchers at Temple University in Philadelphia, US, have discovered that magnets could be used to reduce blood viscosity. The technique, known as magneto-rheology, involves applying...

BioMimetic Completes Patient Enrolment for Augment Rotator Cuff Graft Trial
10 June 2011 BioMimetic Therapeutics has completed patient enrolment in a trial to assess the safety and clinical use of its Augment rotator cuff graft for the repair of large rotator cuff tears. ...

Idaho Technology Receives FDA Clearance for Q Fever Test
09 June 2011 Idaho Technology has received US Food and Drug Administration (FDA) clearance for the first nucleic acid amplification in vitro diagnostic test to detect Coxiella burnetii, the bacteria that...

NICE Approves Eye Implant for Macular Oedema
09 June 2011 The UK National Institute for Health and Clinical Excellence (NICE) has approved a dexamethasone intravitreal implant for the treatment of macular oedema following central retinal vein...

European E. Coli Crisis Prompts Increase in Screening Plate Production
09 June 2011 Thermo Fisher Scientific has increased production and distribution of its Brilliance ESBL Agar plate in the wake of the European E. coli crisis. The product is a chromogenic screening plate...

Provista Develops New Blood Test to Detect Breast Cancer
09 June 2011 Provista has developed a simple blood test to detect breast cancer. The BT test measures five specific blood-based proteins known to have an association with the immune system's response...

Halo Ablation Catheter Used to Treat Barett's Oesophagus
08 June 2011 Researchers in the UK are using the new Halo 360 ablation catheter with an electrode-covered balloon to treat Barrett's oesophagus, a cancerous throat condition. Halo 360 ablation catheter...

Everist Test Found to Predict Colorectal Cancer Recurrence Risk
08 June 2011 Everist Genomics has announced positive results from a study of its OncoDefender-CRC assay, a molecular prognostic test for early-stage colorectal cancer patients. The test is performed...

Microsphere Radiation Therapy Effective Against Liver Metastases
08 June 2011 Sirtex has announced positive results from a study evaluating selective internal radiation (SIR) therapy delivered using SIR-Spheres microspheres as a treatment for liver metastases from...

Scientists Develop Digital Stethoscope to Aid Heart Disease Diagnosis
08 June 2011 A team from Queen Mary's School of Electronic Engineering and Computer Science in London, UK, has helped to develop a digital stethoscope that allows doctors who are not cardiac experts to spot...

Roche and Clovis to Develop EGFR Mutation Test
07 June 2011 Clovis Oncology and Roche have entered into a partnership to develop an in vitro polymerase chain reaction-based companion diagnostic test. The test is expected to identify activating...

DNA Sequencing Used to Detect Pathogenic E. Coli
07 June 2011 Life Technologies, in cooperation with University Hospital Munster in Germany, has performed DNA sequencing using its Ion Personal Genome Machine to diagnose the presence of pathogenic E. coli. ...

Saliva Test Used to Detect Cytomegalovirus Infections in Newborns
07 June 2011 Researchers from the University of Alabama, US, and other academic medical centres successfully used a polymerase chain-reaction-based saliva test to identify cytomegalovirus infections...

Covidien Receives FDA and CE Mark Approval for Hernia Mesh
07 June 2011 Covidien has received US Food and Drug Administration (FDA) and CE Mark approval for its Parietex optimised composite mesh, used for ventral hernia repair. The mesh is engineered to...

UK Researchers Developing Electronic Nose to Detect Necrotising Enterocolitis
06 June 2011 Researchers in the UK are developing an electronic nose to detect necrotising enterocolitis, a serious bowel condition that affects babies. The device uses a modified heated metal oxide...

Antisense Granted Patents for CED Application System
06 June 2011 Antisense Pharma has been granted patents for the new Convection Enhanced Delivery (CED) application system, which for the first time allows long-term and outpatient administration of...

New Onyx Glue to Treat Aneurysms
06 June 2011 Doctors at Brooke Army Medical Center in the US have developed a new glue to treat aneurysms. Brooke Army Medical Center endovascular neurosurgeon Christopher Koebbe said the glue, known...

ConforMIS Completes First Surgeries Using iTotal CR Knee Resurfacing System
06 June 2011 ConforMIS has completed the first surgeries using the iTotal CR knee resurfacing system in the US states of Massachusetts, California and Texas. The system is made to fit into an...

Gene Test Can Predict Chronic Lymphocytic Leukaemia Survival
03 June 2011 Scientists at the UK's Institute of Cancer Research have discovered that a genetic test can predict which patients with chronic lymphocytic leukaemia will not respond well to treatment. ...

fMRI Can Diagnose Language Impairment in Autistic Children
03 June 2011 Researchers at Columbia University in New York, US, have discovered that functional MRI (fMRI) techniques can be used to diagnose language impairment in autistic children. In a study in which...

Norway Awards Funds for hENT1 Biomarker Assay Development
03 June 2011 Clavis Pharma has received a grant of NOK14m ($2.5m) from The Research Council of Norway to develop a flow cytometry method. Flow cytometry is used for the detection and quantification of...

Engineers Develop New Silicon Biosensor for DNA Sequencing
03 June 2011 Engineers at Vanderbilt University in the US have developed a spongy silicon biosensor that can detect the particular DNA sequences that indicate heart disease or certain kinds of cancer. ...

Spectroscopy Device Could Provide Non-Invasive Bladder Dysfunction Diagnosis
02 June 2011 Researchers from the University of British Columbia, Vancouver Coastal Health and the Child & Family Research Institute (CFRI) have developed a wireless near-infrared spectroscopy device...

Indian Institutions to Develop Diabetes Test Kit
02 June 2011 A diagnostic test kit to detect the diabetes cheaply is being developed by the Indian Council of Medical Research, the Council of Scientific and Industrial Research and Indian Institutes...

New Test Predicts Risk of Mitochondrial DNA Disorder Transmission
02 June 2011 Dutch researchers have developed a pre-implantation genetic diagnosis test to predict mothers at risk of passing on mitochondrial genetic disease to their children. They looked at 159...

New Test to Diagnose Hereditary Leiomyomatosis and Renal Cell Cancer
02 June 2011 Researchers at the University of Oxford have developed a cheap and reliable diagnostic test for hereditary leiomyomatosis and renal cell cancer. The test involves screening tumour samples for...

Augurex Blood Test for Rheumatoid Arthritis Shows Promise
01 June 2011 Augurex Life Sciences has reported positive data for its diagnostic rheumatoid arthritis biomarker blood test. The blood test measures 14-3-3Η, a protein that is elevated in the blood...

Boston Scientific Recalls iCross Coronary Imaging Catheter
01 June 2011 Boston Scientific has voluntarily recalled its iCross coronary imaging catheters following eight confirmed occurrences of catheter tip detachment due to embrittlement between 1 April 2010 and...

Artificial Retina Improves Vision in Retinitis Pigmentosa Patients
01 June 2011 Bionic eye, an artificial retina designed for patients with the degenerative and incurable disease retinitis pigmentosa, has been approved by European regulators. Argus II uses a camera...

Emit Corporation Blood and Fluid Warmer Receives US Approval
01 June 2011 Emit Corporation has received US Food and Drug Administration 510(k) clearance for its HypothermX HX100 device. HX100 is designed to warm intravenous fluids, blood or blood products to...

May 2011

Top

Quest Announces ImmunoCAP Study Results
31 May 2011 Quest Diagnostics has announced results from a study of the ImmunoCAP Specific IgE blood test, which is used to diagnose allergies and asthma. The results, compiled from more than two...

Abbott RealTime Molecular Test Receives CE Mark
31 May 2011 Abbott has received European CE mark approval for its RealTime polymerase chain reaction molecular test for cytomegalovirus DNA quantitation in human plasma or whole blood. The assay...

New Blood Test to Detect MRSA Infections
31 May 2011 Scientists have developed a new blood culture test that uses paper strips to detect MRSA infections. The new test only takes five hours to produce a result. Kent Voorhees, a member of...

Blue Light Tool Can Detect Oral Cancer Cells
31 May 2011 Canadian researchers have reported that a device that emits blue light can help to save the lives of patients suffering from oral cancer. The handheld fluorescence visualisation tool...

Abbott Xience Nano Stent Receives FDA Approval
27 May 2011 Abbott has received US Food and Drug Administration (FDA) approval for its Xience nano everolimus-eluting coronary stent system, used for the treatment of coronary artery disease in vessels...

Novamed Develops Home Test to Detect Heart Attacks
27 May 2011 Israeli diagnostic company Novamed has developed a new home diagnostic test to detect heart attacks. The test, SensAheart, analyses blood for troponin and FABP3, both of which are...

New Breath Test to Diagnose Chronic Pancreatitis
27 May 2011 Exalenz Bioscience has announced positive trial data that reveals its BreathID breath test system and 13C-di-peptide substrate could be used to diagnose chronic pancreatitis. The study,...

Blood Test to Diagnose Depression Unveiled
27 May 2011 Researchers at Keio University in Tokyo, Japan, have developed a blood test to diagnose depression. A study conducted by the medical research group Human Metabolome Technologies, involving...

New Heart Monitoring Device Detects Arrhythmia
26 May 2011 Cinterion and TZ Medical have announced that Aera-CT, a lightweight and cost-effective heart arrhythmia monitoring device, improves the condition of patients with arrhythmia disorders. ...

FDA Approves Patient Enrolment for ORBIT II Trial
26 May 2011 Cardiovascular Systems has received US Food and Drug Administration (FDA) approval to complete patient enrolment in the ORBIT II investigational device exemption clinical trial for its...

PET Scans Could Predict Effectiveness of Drug-Resistant Tuberculosis Treatments
26 May 2011 A study published in the Journal of Nuclear Medicine has reported that 18F-FDG PET scans help to predict the effectiveness of treatment for multi-drug resistant tuberculosis in HIV patients. ...

Study Says Vectra DA Blood Test Effective for Rheumatoid Arthritis
26 May 2011 Crescendo Bioscience has announced that Vectra DA, a first-in-class multi-biomarker blood test, can track rheumatoid arthritis activity and provide physicians with a measure to determine...

NADiA ProsVue Test Identifies Prostrate Cancer Recurrence
25 May 2011 IRIS International has announced positive results of a multi-centre clinical study of its proprietary NADiA ProsVue prognostic prostate cancer test in post-radical prostatectomy patients. ...

Scientists Develop New Test for IVF Embryos
25 May 2011 Researchers at Johns Hopkins University School of Medicine in the US have developed a new technique to help couples that are affected by or carry a genetic disease have IVF babies free of...

New Nanoscale Imaging Technology Could Aid Multiple Sclerosis Diagnosis
25 May 2011 Researchers at the University of California Santa Barbara in the US have developed a new method of nanoscopic imaging for use in the early detection and diagnosis of multiple sclerosis and...

Aptus EndoStapling System Receives CE Mark
25 May 2011 Aptus Endosystems has received CE mark approval for its Aptus EndoStapling System, which enables endovascular aneurysm repair. The system provides physicians with a technology to...

Holmium Laser Therapy Effective as Benign Prostatic Hyperplasia Treatment
24 May 2011 Researchers at McGill University Health Centre in Canada have demonstrated that holmium laser therapy is a safe and durable treatment option for benign prostatic hyperplasia, an enlargement of...

CT Scan Could Predict Early Death in Diabetic Patients
24 May 2011 Researchers at Wake Forest Baptist Medical Center in the US have revealed that a common test could predict early death in individuals with diabetes. A high coronary artery calcium score...

Boston Stent System Proven Effective for Small Vessel Coronary Disease
24 May 2011 Boston Scientific has announced positive results from its PLATINUM Small Vessel study of 2.25mm Promus Element everolimus-eluting platinum chromium stent system, used in treating small...

Neonatal Heart Defect Test Could Become Compulsory
24 May 2011 St Joseph's Regional Medical Center in the US is performing a test in newborns to detect heart disease that could be made compulsory should New Jersey Governor Chris Christie sign a new law...

Pioneers in Implant Technology and Medical Research Receive European Inventor Award
23 May 2011 Pioneers in implant technology and medical research have been awarded the European Inventor award 2011 by the European Patent Office (EPO). Per-Ingvar Branemark of Sweden has received...

Biotronik Metal Scaffold Device Shows Positive Results
23 May 2011 Biotronik has reported positive six-month results from the Biosolve-I first-in-man (FIM) trial studying the Drug-Eluting Absorbable Metal Scaffold (DREAMS), which is used to treat patients...

GTx Announces Positive Results from Ostarine Trial
23 May 2011 GTx has announced positive results from a phase IIb clinical trial evaluating Ostarine, a selective androgen receptor modulator that could be used to treat muscle wasting in cancer patients. ...

Abbott HCV Test Receives FDA Approval
23 May 2011 Abbott has received US Food and Drug Administration (FDA) approval to market its real-time polymerase chain reaction test, which is used to measure the viral load of hepatitis C (HCV), the...

Oraya Completes Enrolment for Radiotherapy System Study
20 May 2011 Oraya Therapeutics has completed patient enrolment for its INTREPID clinical trial of the IRay stereotactic radiotherapy system in Europe. The study is the first sham-controlled,...

Medtronic CoreValve System Demonstrates Quality of Life Improvements
20 May 2011 Medtronic has published results from a study that indicates its CoreValve System leads to immediate and long-term quality of life improvements. The two-year study was conducted at nine...

Maquet Receives CE Mark for Cardioroot Aortic Graft
20 May 2011 Maquet Cardiovascular has received European CE mark approval for its Cardioroot aortic graft, which is used to repair or replace diseased and damaged aortas. The graft allows easy sewing...

EnteroMedics Reports First Maestro Rechargeable System Implantation
20 May 2011 EnteroMedics has announced the first implants of its Maestro Rechargeable System, used for treating obesity. The ReCharge trial, a randomised, double-blind, parallel-group, multicentre...

FDA Grants Expedited Review Status for Cancer Device
19 May 2011 The US Food and Drug Administration (FDA) has accepted the pre-market approval application filed by Dune Medical Devices for its MarginProbe System. The FDA also granted the device an...

Avinger Reports Positive Results for Wildcat CTO Crossing Study
19 May 2011 Avinger has recorded positive results from its Wildcat Catheter in crossing chronic total occlusions (CTOs) in femoropopliteal lesions that cause amputation for patients suffering from...

US Infusion Therapy Device Market to Exceed $6.6bn by 2017
19 May 2011 The value of the US infusion therapy device market is forecast to exceed $6.6bn by 2017, according to iData Research. The report revealed that market growth will be driven by the increasing...

CryoLife Acquires Cardiogenesis Corporation
19 May 2011 CryoLife has acquired Cardiogenesis Corporation, thereby strengthening its position in surgical products used to treat patients with severe angina, and expanding its portfolio in cardiac...

Canadian Province Approves Colorectal Cancer Test Use
18 May 2011 The Canadian province of Saskatchewan has licensed the right to use a diagnostic blood test to detect colorectal cancer in its early, curable stages. The blood test, developed by...

Study Says Calypso System Delivers Accurate Radiation
18 May 2011 Calypso Medical has reported positive results from a study of its Calypso System, which enables the accurate delivery of radiation in post-prostatectomy patients. The study involved 17...

New Hereditary Breast Cancer Test Can Cut Costs
18 May 2011 UK-based NewGene has developed a test for hereditary breast cancer that is more time and cost-effective than conventional methods. NewGene uses the Roche 454 GS-FLX next-generation...

Masimo SpHb Monitoring Accurately Measures Haemoglobin and Haemorrhage
18 May 2011 Researchers at Madigan Army Medical Center in Tacoma, Washington, US, have reported the accuracy and reliability of Masimo non-invasive and continuous haemoglobin (SpHb) monitoring for...

MDxHealth Methylation Test Could Reveal Missed Prostate Cancers
17 May 2011 MDxHealth has reported results from a study demonstrating that changes in DNA methylation patterns in benign tissue could predict an adjacent prostate cancer. The test delivers a...

Six-Minute Walking Test Measures Disease Severity in COPD Patients
17 May 2011 The six-minute walking distance test, which measures a patient's ability to tolerate exercise and physical activity, can be an effective tool for understanding disease severity in patients...

NeuroStar TMS Therapy Effective Against Major Depressive Disorder
17 May 2011 NeuroStar transcranial magnetic stimulation (TMS) therapy has showed effective outcome and adherence rates in patients with major depressive disorder. The open-label study, conducted at...

New Online Test to Help Detect Alzheimer's Developed
17 May 2011 Scientists at Oxford University in the UK have developed a 15-minute online test to detect the early signs of Alzheimer's disease. The Cognitive Function Test includes three sections, and...

Given Imaging's PillCam Able to Detect Colorectal Polyps
16 May 2011 Given Imaging has announced positive results from the European multicentre study of PillCam Colon 2, a video capsule used to detect colorectal polyps. The device is equipped with two...

iCAD Receives Chinese Regulatory Approval for SecondLook Digital
16 May 2011 iCAD has received Chinese regulatory approval for its SecondLook Digital computer-aided detection (CAD) technology, which can aid cancer diagnosis. The CAD technology has been included...

OVA1 Ovarian Cancer Blood Test Proven Accurate
16 May 2011 Quest Diagnostics has reported that the OVA1 blood test has been found to be a more accurate detector of ovarian cancer than the medically accepted CA 125 blood test in a clinical study. ...

Scientists Reveal New Method to Map Myelin Sheath Deterioration
16 May 2011 Researchers from the Niels Bohr Institute at the University of Copenhagen in Denmark have developed a new SAXS-CT method to map the myelin sheaths of nerve cells, which are important in...

AspirinWorks Test Determines Effect of Aspirin on Platelets
13 May 2011 Corgenix Medical has developed the AspirinWorks Test to determine the effect of aspirin on platelets. AspirinWorks, available through Diagnostic Laboratory Medicine, is the only...

New Non-Invasive Test Detects Pancreatic Cancer
13 May 2011 Researchers of Mayo Clinic reported positive results of a new non-invasive test, used to detect pancreatic cancer with DNA testing of patient’s stool samples. The study aimed at...

CyberKnife Sites Performs SBRT to Treat Prostrate Cancer
13 May 2011 Accuray has announced that 85% of European CyberKnife centres are implementing prostate Stereotactic Body Radiation Therapy (SBRT) to treat localised prostate cancer. The CyberKnife...

NovaVision Unveils Benefits of Vision Restoration Therapy
13 May 2011 NovaVision has announced the benefits of its clinically supported, light stimulation-based Vision Restoration Therapy (VRT) to diagnose and improve visual function in patients who have suffered...

ImThera Completes Clinical Study of aura6000
12 May 2011 ImThera has completed Phase I and Phase II trials for the European pilot study of aura6000, a neurostimulation device to treat obstructive sleep apnoea. The device, which is based on...

Luminex Gastrointestinal Pathogen Panel Receives CE Mark
12 May 2011 Luminex has announced that it has received the CE mark for its new xTAG gastrointestinal pathogen panel, which can identify up to 95% of gastrointestinal disease-causing pathogens in a single...

US Scientists Develop New Imaging Method
12 May 2011 Researchers at Columbia Engineering School in the US have developed a new electromechanical wave-imaging method, the first non-invasive, direct technique to map the electrical activation in...

Cellular-Level Visualisation with Cellvizio Effective for Detecting Bilio-Pancreatic Cancer
12 May 2011 Mauna Kea has announced that the cellular-level visualisation of the lining of the bile and pancreatic ducts with its Cellvizio probe-based confocal laser endomicroscopy (pCLE) system...

Covidien Completes Patient Enrolment for Hernia Mesh Study
11 May 2011 Covidien has completed the enrolment of 600 patients for a clinical study of Parietex ProGrip self-fixating mesh, which could be used to repair inguinal hernias. Parietex ProGrip...

ArtVentive Endoluminal Occlusion Device Shows Promise in Animal Studies
11 May 2011 ArtVentive Medical has announced that its endoluminal occlusion device has treated target vessels in regulatory animal studies. The study conducted at Johns Hopkins University and...

Bravo Wireless pH Monitoring System Manages GERD
11 May 2011 Given Imaging has announced the benefits of using the Bravo wireless pH monitoring system to analyse pH levels in patients with gastroesophageal reflux disease (GERD). The system uses a...

Septin9 Blood Test Detects Colorectal Cancer
11 May 2011 Researchers at the School of Medicine of Stanford University in the US have announced positive results from a study of Septin9 blood tests, which could be used to screen for colorectal...

PENTAX and Hitachi Join Forces to Develop Endoscopic Ultrasound Systems
10 May 2011 The PENTAX Medical Company has announced renewed joint collaborative efforts with Hitachi-Aloka to provide further innovations in the development of endoscopic ultrasound systems. The...

Boston Scientific Reports First Cardiac Defibrillator Implantation
10 May 2011 Boston Scientific has announced the first implants of its Energen and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs)...

Impella Improves Blood Circulation
10 May 2011 The Protect II study has reported positive results of the Impella 2.5 device, designed to enhance blood circulation and support blood pressure in high-risk patients undergoing percutaneous...

BD Introduces BD MAX Open System in Europe
10 May 2011 BD Diagnostics has announced the launch of the BD MAX open system for molecular testing, which is intended to become the laboratory equivalent of a smartphone. BD MAX is a fully automated,...

SwabCap Found to Reduce Bloodstream Infection Risk
09 May 2011 Coram has announced positive results of the SwabCap disinfection cap, a twist-on device that disinfects swabable needleless IV connectors in between line accesses. In a study the device...

Boston Scientific Reports New Catheter Implantation
09 May 2011 Boston Scientific has announced the first launch of its Blazer open-irrigated catheter at the Cardiologique du Haut–Leveque Hospital in Bordeaux–Pessac, France. The catheter is attached to...

Microvolt T-Wave Alternans Detects Sudden Cardiac Arrest
09 May 2011 Cambridge Heart has announced that Microvolt T-wave Alternans testing has confirmed diagnostic value in identifying patients at risk of sudden cardiac arrest. The research conducted at...

Caldera Desara Mini Receives CE Mark
09 May 2011 Caldera Medical has announced that it has received CE mark approval for its Desara Mini implant, used in the treatment of stress urinary incontinence. The implant, combined with Desara...

FDA Clears Sectra Cancer Detector
06 May 2011 Sectra announced that its Microdose mammography modality has received US Food and Drug Administration (FDA) clearance. The MicroDose detector is based on photon-counting technology. ...

MicroPulse Treatment Effective Against Diabetic Macular Oedema
06 May 2011 Iridex Corporation has announced the benefits of MicroPulse photocoagulation technology over the standard-of-care treatment for diabetic macular oedema retinal damage caused by...

Cameron Enrols Patients for Clinical Study of S-ICD
06 May 2011 Cameron Health has announced that it has completed enrolment in its clinical study of the Subcutaneous Implantable Defibrillator (S-ICD) system. The S-ICD system detects highly accelerated...

EBR Reports First WiCS Implantation
06 May 2011 EBR Systems has announced the first human implants of the Wireless Cardiac Stimulation System (WiCS), which stimulates the heart through the wireless transmission of energy. The study found...

Femasys Receives FDA Clearance for FemVue Saline-Air Device
05 May 2011 Femasys has announced that its FemVue Saline-Air device has received US Food and Drug Administration (FDA) approval. The device, designed for diagnostic Sono HSGs, allows doctors to assess...

Electrical Stimulation Therapy Proven Effective for Retinitis Pigmentosa
05 May 2011 Okuvision has announced that its electrical stimulation therapy has proven effective in early-stage retinitis pigmentosa patients during a sham-controlled pilot study. The study involved...

Lymphoseek Detects Lymph Nodes
05 May 2011 Neoprobe has announced results from its Lymphoseek (tilmanocept) NEO3-09 study. The Phase III clinical study enrolled 150 subjects with either breast cancer or melanoma within...

NIH Funds Chagas Test Clinical Trial
05 May 2011 Immunetics has received a $2.4m, three-year Phase II SBIR grant from the US National Institutes of Health (NIH) to support clinical trials of its new test for Chagas disease, a potentially...

Sorin Introduces Endoscopic Vessel Harvesting System
04 May 2011 Sorin Group has introduced its VascuClear endoscopic vessel harvesting system to replace its existing product offering. The system possesses features such as open carbon dioxide system,...

Idaho Technology Receives FDA Approval for Respiratory Panel
04 May 2011 Idaho Technology has received US Food and Drug Administration (FDA) 510(k) clearance for its FilmArray instrument and FilmArray respiratory panel, a nucleic acid test to detect viral nucleic...

Medtronic Completes First Patient Procedure for Diagnostic Catheter
04 May 2011 Medtronic has completed the first patient procedure using its Achieve Mapping Catheter, an intra-cardiac electrophysiology diagnostic catheter. The catheter can assess pulmonary vein...

TowerJazz and Medigus Launch Miniature Camera for Endoscopic Devices
04 May 2011 Medigus and TowerJazz have introduced the second generation of the world's smallest camera for medical disposal endoscopic devices. Disposable cameras exclude the need for the expensive...

Dune MarginProbe System Enables Cancer Detection
03 May 2011 Dune Medical Devices has announced that its first commercial product, the MarginProbe system, has met its primary endpoints of a trial to detect cancer at or near the surface of excised...

Defibtech Recalls DDU-100 Series AEDs
03 May 2011 Defibtech has initiated a voluntary Class I recall of DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885...

Mammography Found to Detect Smaller Breast Tumours Than Clinical Exams
03 May 2011 Researchers at the University of Missouri in Columbia, US, have reported that mammography detects smaller tumours with less nodal metastasis than clinical breast exams among women between 40 and...

D Medical Subsidiary Receives FDA Approval to Market its Insulin Pump
03 May 2011 D Medical Industries subsidiary Spring-Set Health Solutions has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Spring Universal Infusion Sets in the...

April 2011

Top

EnteroMedics Expects to Implant Obesity Device in US by Year End
28 April 2011 EnteroMedics said that it expects to implant the first patient with its obesity controlling device by the second quarter of the year. The company is developing implantable systems to...

Amerinet and Teleflex Sign Agreement for Peripherally Inserted Central Catheters
28 April 2011 Teleflex said it signed a new three-year multisource agreement effective from 1 May 2011 to 30 April 2014 with Amerinet, a national healthcare group purchasing organisation. Amerinet chose...

Biomet Receives FDA Approval for Active Articulation Dual Mobility Hip System
28 April 2011 Biomet has received US Food and Drug Administration Approval of its Active Articulation E1 dual-mobility hip system. The company’s first hip system will converge the benefits of...

SpinalMotion Begins Patient Enrolment for Kineflex Cervical Disc Trial
28 April 2011 SpinalMotion, developer of the innovative technology for the treatment of patients suffering from degenerative disc disease, announced that it has started enrolling patients for a clinical study...

Dehaier to Develop Oxygen Therapy Products in China
27 April 2011 Dehaier Medical Systems has signed a tripartite strategic cooperation agreement with Taiyo Nippon Sanso Shenwei Medical Gas and Beijing Orient Medical Gas to develop oxygen therapy services for...

MedPro Establishes Ultrasound Transducer Repair Facility in US
27 April 2011 MedPro Imaging has opened its ultrasound transducer repair facility in Longmont, Colorado, US. The 5,000ft² facility features proprietary repair technology, offering...

SI-Bone Receives FDA Approval for Modified iFuse Implant System
27 April 2011 SI-BONE has received US Food and Drug Administration (FDA) approval for a major modification to its existing iFuse Implant System product, which is used to treat conditions such as sacroiliac...

Blood-Activated Sensor Could Detect Pancreatitis
27 April 2011 Scientists at the University of Texas in the US have developed a low-cost sensor to detect acute pancreatitis quickly and easily. The sensor, which is about the size of a matchbox and...

Non-Invasive Masimo Carboxyhaemoglobin Measurements Proven Effective
26 April 2011 Non-invasive Masimo carboxyhaemoglobin (SpCO) measurements provide an effective means for screening at-risk populations for carbon monoxide poisoning, a study has found. Researchers at...

New Pelvic-Repair Device Facilitates Minimal Surgery
26 April 2011 A pelvic-repair device developed by surgeons at the University of Texas Southwestern could minimise postsurgical scarring, pain and infection risk. The device, the Starr Frame and...

Test Proved Effective For Tuberculosis Diagnosis
26 April 2011 A study published in the Lancet has found that the Xpert MTB/RIF test can effectively diagnose tuberculosis. The cartridge-based, automated diagnostic test uses a real-time polymerase...

Gore Excluder Endoprosthesis Procedure Conducted in Australia
26 April 2011 WL Gore & Associates have reported the first clinical use of the Gore C3 Delivery System to set out the Gore Excluder AAA Endoprosthesis to treat an abdominal aortic aneurysm in...

Eye Specialists Discover Chronic Diseases First
21 April 2011 Eye exams are generally the first to detect chronic diseases such as diabetes and hypertension, a study by the Human Capital Management Services Group has revealed. The study, which...

ICD Patients Experience Complications, Study Shows
21 April 2011 Implantable cardioverter defibrillators (ICDs), which prevent sudden death in cardiac patients, can also cause complications, a study by the Institute for Clinical Evaluative Sciences (ICES) and...

Breath Test Could Detect Cancer
21 April 2011 A breath test that can help detect cancer is one step closer to reality, according to a preliminary study published by researchers at the Israel Institute of Technology. The research...

New Test Could Reduce Prostate Cancer Screening False Positives
21 April 2011 Researchers from Northwestern Medicine have found that a new prostate-specific antigen (PSA) screening test for prostate cancer can detect aggressive forms of the disease and substantially...

New Screening Method to Help Diagnose Lipid Storage Disorders in Children
20 April 2011 Researchers of Columbia University have discovered a yeast-based screening 'exacerbate-reverse' method to diagnose treatment for fatal childhood disease Niemann-Pick C, an autosomal recessive...

Bone Suppression Device Can Improve Lung Cancer Detection, Study Finds
20 April 2011 Using Riverain Medical's SoftView device in conjunction with chest X-rays can help in the detection of lung disease and lung cancer, according to a study published in Radiology. Radiologists...

Carmell Raises Funds to Develop Blood-Plasma Devices
20 April 2011 Carmell Therapeutics, an early-stage manufacturer of novel blood plasma-based biomaterials used in the repair of injured tissues, has completed series A financing to establish a pilot...

Medtronic and US Hospital Begin Patient Enrolment for Heart Valve Trial
20 April 2011 Medtronic and Loyola University Hospital in Illinois, US, have begun patient enrolment for a clinical trial of a non-surgical heart valve replacement. Loyola is among the 40...

Synthes in Talks with Johnson & Johnson for Possible Takeover
19 April 2011 Synthes has said it is in takeover talks with Johnson & Johnson following reports that the US group is thinking about buying the device maker for $20bn. "In response to market...

CSA Group Acquires Devices Testing Firm
19 April 2011 CSA Group has acquired INTRATest, a product testing business with focus on medical devices and laboratory equipment, and has also entered into a medical testing agreement with Eurocat Institute...

New Test to Identify Cancer Patients Who Could Benefit From Diabetes Drug
19 April 2011 Scientists from the University of Manchester in the UK and Thomas Jefferson University in the US have developed a test to identify breast cancer patients who would benefit from treatment...

FDA Approves Device to Treat Glioblastoma Multiforme
19 April 2011 The US Food and Drug Administration (FDA) has approved the NovoTTF-100A System, a portable device to treat adults with glioblastoma multiforme that recurs or progresses after chemotherapy...

Artificial Pancreas May Improve Diabetes Control in Adults
18 April 2011 An artificial pancreas may improve overnight blood-glucose control and reduce the risk of nocturnal hypoglycaemia in adults with type 1 diabetes, according to new studies. The...

Researchers to Evaluate Urine Tests for Prostate Cancer Diagnosis
18 April 2011 Researchers at Beth Israel Deaconess Medical Center in the US have initiated a study to evaluate whether new urine-based tests that identify genetic abnormalities present in prostate cancer...

Researchers Identify Biomarkers to Predict Metastasis Risk
18 April 2011 Scientists at Yale University in the US have identified a set of plasma biomarkers that could predict the risk of metastasis among patients with melanoma. Researchers tested plasma of...

Hitachi Medical Receives FDA Approval for CT System
18 April 2011 Hitachi Medical Systems America has received approval from the US Food and Drug Administration (FDA) for its Scenaria CT system. The Scenaria CT system is designed to acquire 64-slices in...

UK Scientists Develop Needle-Free Medicine Test for Premature Babies
15 April 2011 Scientists at Queen's University Belfast in the UK have developed a needle-free test for medicine testing in premature babies. Medicine testing in premature babies is used to calculate the...

XDx Receives CE Mark for Heart Transplant Test
15 April 2011 XDx has received the European CE mark for its AlloMap molecular expression test, which is used for heart transplant surveillance monitoring. The AlloMap test provides transplant physicians...

Brain Scans Could Predict Alzheimer's Risk
15 April 2011 Brain scans could be used to predict the development of Alzheimer's disease up to a decade before symptoms develop, according to a study published in Neurology. Researchers at Rush...

Pico-Tesla Device Reduces Fibromyalgia Symptoms in Study
15 April 2011 Pico-Tesla has reported that the therapy delivered by its Resonator system improved pain and sleep symptoms in patients with fibromyalgia in a pilot study. The randomised,...

Wrist Circumference May Predict Cardiovascular Risk
14 April 2011 Measurements of wrist circumference could be used to identify overweight children or adolescents at increased risk of developing insulin resistance and cardiovascular disease. In a...

Blood-Flow Boosting Skin Patch Could Treat Alzheimer's
14 April 2011 Researchers at US firm Clarimedix have developed a skin patch that can treat Alzheimer's disease by boosting blood flow to the brain. The patch, about the size of a matchbox, is designed to...

Researchers Discover Biomarkers to Predict Multiple Sclerosis Progression
14 April 2011 Researchers at the Mayo Clinic in the US have discovered two biomarkers that can predict the rate of progression in patients with progressive multiple sclerosis. For the study,...

Savi Radiation Device Safe for Women with Breast Implants, Study Finds
14 April 2011 Savi, a multicatheter brachytherapy device, can be used to safely deliver post-lumpectomy radiation therapy to women with breast implants, according to a study published in medical...

Cerapedics Reports Positive Results from Bone Graft Study
13 April 2011 Cerapedics has reported positive results from the trial of its i-Factor biologic bone graft for patients undergoing posterior lumbar interbody fusion spine procedures. At six and 12...

US Researchers Develop Prediction Model for Kidney Disease
13 April 2011 Researchers at Tufts Medical Center in the US have developed a model that can accurately predict the short-term risk of kidney failure in patients with moderate to severe chronic kidney disease. ...

Positive Results from PositiveID Glucose Device Study
13 April 2011 PositiveID has reported that its Easy Check breath glucose detection device has delivered encouraging results in preliminary laboratory testing. The results were within acceptable...

Enigma Begins Trials of Influenza Detection Assay
13 April 2011 Enigma Diagnostics has initiated clinical trials for its point-of-care Enigma ML influenza A/B detection assay. The Enigma ML system combines fully-automated sample extraction with a...

Researchers Develop Heart Attack Warning Device
12 April 2011 Researchers at Angel Medical Systems have developed a device that can let users know they are experiencing symptoms of a heart attack before it becomes obvious. The implantable device, known...

New Smartphone Application Could Diagnose Malaria
12 April 2011 A research team from University of Central Florida, US, has developed a new smartphone application that can help in rapid diagnosis of malaria. The team's prototype is a Windows...

Thoughts Used to Move Computer Cursor
12 April 2011 Researchers at Washington University in St Louis, US, have shown that electrocorticography can allow people to control a cursor on a computer screen through thoughts about vowel sounds...

FDA Clears First Test to Diagnose Dengue
12 April 2011 The US Food and Drug Administration (FDA) has allowed the marketing of the first test to help diagnose people with the signs and symptoms of dengue fever or dengue haemorrhagic fever. The...

Spectranetics to Initiate In-Stent Restenosis Device Trial
11 April 2011 Spectranetics Corporation is planning to conduct a study to evaluate excimer laser atherectomy using its Turbo-Tandem and Turbo Elite products in patients with femoropopliteal in-stent restenosis....

Deep Brain Stimulation Could Treat Tremors
11 April 2011 Deep brain stimulation could allow patients to stop using medications to treat their essential tremors within a year after surgery, a study carried out at the University of South Florida, US,...

Myconostica Aspergillosis Test Shows Positive Results in Study
11 April 2011 Myconostica has reported positive results from a study evaluating MycAssay Aspergillus, which is designed to diagnose invasive Aspergillosis using serum samples. The trial tested 31...

NewCardio Technology Improves Acute Myocardial Infarction Diagnosis
11 April 2011 NewCardio has reported that its my3KG technology showed greater accuracy than expert cardiologists' interpretation of standard 12-lead ECG in diagnosing acute myocardial infarction in...

UK Researchers Develop Stroke Rehabilitation Devices
08 April 2011 Researchers at the University of Southampton in the UK have developed devices that could be used to rehabilitate the arms and hands of people who have had a stroke. The three devices —...

Boston Scientific Initiates Peripheral Vascular Lesions Stent Trial
08 April 2011 Boston Scientific Corporation has initiated patient enrolment in a trial to evaluate its Innova self-expanding, bare-metal stent system in patients with stenosis of the superficial femoral...

Neuros Pain-Reduction Technology Tests Well
08 April 2011 Neuros Medical has reported positive results from a study evaluating its high-frequency electrical nerve-block technology in patients with chronic amputation pain. In the study, four out...

ICDs Linked to Longer Survival in Cardiac Patients
08 April 2011 Most patients with ischaemic cardiomyopathy and dilated cardiomyopathy who have received an implantable cardioverter-defibrillator (ICD) now live more than seven years, according to a...

New Device Developed to Treat Resistant Hypertension
07 April 2011 Researchers at CVRx have developed a device that can lower blood pressure in people with resistant hypertension. The Rheos System works by activating the body's natural blood-flow...

FDA Approves NeuroVasx Cerebral Aneurysm Device
07 April 2011 The US Food and Drug Administration (FDA) has approved NeuroVasx's cPAX Aneurysm Treatment System as a humanitarian use device for the treatment of large, giant and wide-neck cerebral aneurysms. ...

Researchers Identify Genes to Predict Alzheimer's Risk
07 April 2011 A consortium of investigators from 44 US universities and research institutions has identified four genes that can increase a person's risk of developing Alzheimer's disease later in life. ...

New Test Could Detect Asbestos-Related Cancer
07 April 2011 A study conducted at New York University's Langone Medical Center has shown that the novel Multiplex SOMAmer Assay can accurately detect early-stage, asbestos-related pulmonary cancer, also...

New Test Could Identify Lung Cancer in Non-Smokers
06 April 2011 Researchers at Celera Corporation have developed a biomarker-based serum test to identify lung cancer in people who have never smoked. To establish the biomarkers, researchers examined...

Breast Milk Could be Used to Assess Breast Cancer Risk
06 April 2011 Examining the epithelial cells present in breast milk may help to evaluate a woman's breast cancer risk, according to a study conducted at the University of Massachusetts Amherst in the...

Ventus Reports Positive Results from Sleep Apnoea Device Study
06 April 2011 Ventus Medical has reported positive results from a clinical trial evaluating its US Food and Drug Administration-cleared Provent Therapy device, which is used to treat obstructive sleep apnoea. ...

Positive Results from Boston Scientific Coronary Stent Trial
06 April 2011 Boston Scientific has reported positive 12-month results from a trial comparing the safety and effectiveness of the Promus Element everolimus-eluting platinum chromium coronary stent system...

Edwards Reports Positive Results from Aortic Valve Study
05 April 2011 Edwards Lifesciences Corporation has reported positive results from Cohort A of a trial evaluating the Edwards SAPIEN transcatheter aortic valve in high-risk surgical patients with severe...

Cardiac Biomarker Could Predict Heart Failure Risk
05 April 2011 T2, a cardiac biomarker, can help physicians to better predict the prognosis and development of cardiovascular complications such as heart failure, according to three new studies. In the...

Abbott Reports Positive Results from Vascular Scaffold Study
05 April 2011 Abbott has reported positive one-year results from the second phase of a trial evaluating the ABSORB device, the world's first drug-eluting bioresorbable vascular scaffold for the treatment...

Researchers Discover New Way to Predict Breast Cancer Survival
05 April 2011 A team of researchers at the University of California San Francisco has discovered that an immune profile based on relative levels of three types of immune cells within a tumour can...

NeuroLogica CT Scanner Receives FDA Approval
04 April 2011 NeuroLogica Corporation has received 510(k) clearance from the US Food and Drug Administration (FDA) for BodyTom, the world's first portable, full body, multi-slice CT scanner. ...

Non-Tumour Tissue Analysis May Help to Diagnose Prostate Cancer
04 April 2011 Non-tumour tissue could be used to diagnose prostate cancer, a study published by the American Association for Cancer Research has reported. Researchers at University of California,...

New Staging to Improve Prediction of Lung Cancer Recurrence
04 April 2011 The new TNM 7 lung cancer staging system could be a better predictor of local recurrences of lung cancer following surgery, a study published in the Journal of Thoracic Oncology has...

Malaysian Researchers Develop Sick Leave Verification Device
04 April 2011 Malaysian researchers have developed SickVerify, a new medical device that can determine if someone is actually sick when they claim sick leave. The device, which looks similar to a USB...

US Researchers Develop Non-Invasive Blood-Glucose Detector
01 April 2011 Researchers at University of Missouri–St Louis in the US have developed a portable, inexpensive and non-invasive blood glucose detector. The device works by shining a near-infrared...

PhotoMedex Reports Positive Results from Psoriasis Device Study
01 April 2011 PhotoMedex has reported positive preliminary results from a clinical trial evaluating the excimer laser system, Xtrac Velocity 700, in patients with moderate to severe psoriasis. The...

CT Scans for Testicular Cancer Linked to Secondary Malignancies
01 April 2011 Researchers at University of California, Davis have found that older men with early-stage testicular cancer who opt for surveillance with regular CT scans are at high risk of developing...

Scientia Microcatheter Receives CE Mark
01 April 2011 Scientia Vascular has received European CE Mark for Plato Microcatheter, which is indicated for use in neuro, cardio and peripheral endovascular applications. The device, which is...

March 2011

Top

New Device Could Capture Cancer Cells
31 March 2011 A Harvard bioengineer and an MIT aeronautical engineer have developed a device that can detect individual cancer cells in blood sample, enabling doctors to identify if the cancer has spread...

GI Dynamics Reports Positive Results from Obesity Device Study
31 March 2011 GI Dynamics has reported results from three studies that demonstrated the positive effects of the EndoBarrier Gastrointestinal Liner on type 2 diabetes, weight loss and other metabolic factors. ...

Biotronik Completes Patient Enrolment in Cardiac System Trial
31 March 2011 Biotronik has completed patient enrolment for a clinical trial evaluating the Biotronik Home Monitoring system for patients with chronic heart failure. Biotronik Home Monitoring is...

Navy Device Could Diagnose Stroke Trauma Quickly
31 March 2011 US Navy sonar experts have developed a medical device that uses submarine technology to detect, diagnose and monitor stroke and brain trauma. The device, which features a simple headset...

Chembio Develops Assays for Rapid Disease Diagnosis
30 March 2011 Chembio has developed a testing approach known as Dual Path Platform technology, which can help in the rapid diagnosis of HIV, influenza A and B, and hepatitis B and C. The point-of-care...

Medtronic Receives FDA Approval for New Defibrillators
30 March 2011 Medtronic has received approval from the US Food and Drug Administration (FDA) for their Protecta portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac...

Non-Invasive Haemoglobin Sensor Useful During Surgery
30 March 2011 A spectrophotometric haemoglobin (SpHb) sensor may be an effective way to non-invasively monitor blood haemoglobin levels during surgery, according to a study published in Anesthesia...

Pathway Begins Patient Enrolment in Peripheral Arterial Disease Study
30 March 2011 Pathway Medical Technologies has enrolled the first patient in a study to evaluate its Jetstream G3 System, which is designed for the treatment of peripheral arterial disease. The...

US Researchers Identify New Colon Cancer Marker
29 March 2011 Researchers at the University of Colorado Cancer Center in the US have identified an enzyme that could be used for the early diagnosis of colon cancer. For the study, researchers studied...

Emerging Embolic Protection Devices Market to Reach $93.3m by 2015
29 March 2011 The embolic protection devices market for emerging countries (Brazil, Russia, India, China, South Africa and South Korea) is estimated to reach $93.3m by 2015, according to a report by Research...

Spinal Neuromodulation Device Could Reduce Back Pain
29 March 2011 A novel spinal neuromodulation device known as the Nevro system can relieve back pain in patients who have not found relief through conventional spinal cord stimulation, according to a...

New Test Could Identify Loose Artificial Joints
29 March 2011 Researchers at Royal Liverpool University Hospital in the UK have developed a blood test that can identify if the attachment between the artificial joint and the bone has become loose. ...

FDA Approves Medtronic CRT-P Systems
28 March 2011 Medtronic has received approval from the US Food and Drug Administration (FDA) for its Consulta and Syncra cardiac resynchronisation therapy pacemaker (CRT-P) systems. A CRT-P is...

Magnetic Therapy May Not Improve Tinnitus
28 March 2011 Magnetic therapy may not improve tinnitus, a condition characterised by constant ringing in the ears, according to a study conducted at Washington University School of Medicine in the...

Brain Stimulation Could Improve Swallowing Ability in Stroke Patients
28 March 2011 Non-invasive brain stimulation can improve swallowing ability in ischaemic stroke patients, according to a study published in Stroke: Journal of the American Heart Association. The...

Verathon Medical Unveils GlideScope Direct Intubation Trainer
28 March 2011 Verathon Medical UK has added the GlideScope direct intubation trainer to its GlideScope range to improve the teaching of basic direct laryngoscopy skills. GlideScope Direct...

Cardiac Pacemaker Could Prevent Epileptic Falls
25 March 2011 Mayo Clinic researchers in the US have found that cardiac pacing may help epilepsy patients with seizure-related falls caused due to ictal asystole, a condition in which the heart stops...

New Method Developed to Detect Epileptic Seizures
25 March 2011 Researchers at Concordia University in Canada have developed a computer-based method to detect epileptic seizures as they occur. To know about timing and nature of seizures, the...

Sensitive New Test Effective for Identifying Heart Attacks
25 March 2011 A highly sensitive blood test is more effective at identifying heart attacks in patients than other available tests, according to a new study by researchers at Edinburgh University in the...

Coronary Calcium Test Could Lower Heart Disease Risk
25 March 2011 Coronary artery calcium scanning test can motivate patients to adopt a healthy lifestyle and lower their heart disease risk factors, according to a new study by researchers at Cedars-Sinai...

Freshmedx Reports Positive Results from Lung Cancer Test Study
24 March 2011 Freshmedx has reported positive results from a clinical trial of computerised bioconductance test (CB Test), a lung cancer test that is used to distinguish between benign and...

New Nanomodified Surfaces Could Seal Leg Implants
24 March 2011 Researchers at Brown University in the US have developed two nanomodified surfaces for titanium leg implants, which promote skin cell growth and seal implants to prevent bacterial infection. ...

Neurotez Develops Test to Predict Alzheimer’s Risk
24 March 2011 Researchers at Neurotez have developed a new test to predict an individual's risk of developing Alzheimer's disease. The test works by analysing a patient sample to determine both APOE...

NeoTract Initiates Patient Enrolment in Prostate Device Study
24 March 2011 NeoTract has enrolled the first US patients in a multinational trial of its UroLift system, which is designed to treat benign prostatic hyperplasia (BPH). The trial will be conducted across...

Positive Results from Covidien Inguinal Hernia Mesh Study
23 March 2011 Covidien has reported positive interim results from a study comparing the use of its Parietex ProGrip self-fixating mesh for inguinal hernia repair to the traditional Lichtenstein repair. ...

Global Cardiac Pacemakers Market to Reach $5.1bn by 2015
23 March 2011 The global cardiac pacemakers market is expected to reach $5.1bn by 2015, according to a report by Research and Markets. The market is likely to grow at a compound annual growth rate (CAGR)...

Orthodontic Retainers May Harbour Harmful Microbes, Study Warns
23 March 2011 Orthodontic retainers, removable devices used to keep teeth straight, can harbour harmful microbes if they are not cleaned properly, a study conducted at the UCL Eastman Dental Institute in the...

New HPV Test Proven Effective for Cervical Cancer Detection
23 March 2011 A new test for human papillomavirus (HPV) is more effective at detecting cervical cancer and has fewer false positives when compared to the old one, a new study published in the Journal of...

CSI Receives FDA Approval for Peripheral Arterial Disease Device
22 March 2011 Cardiovascular Systems (CSI) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Stealth 360 Orbital PAD System, a device designed for the treatment of...

US Researchers Develop Blood Test to Predict Diabetes Risk
22 March 2011 Researchers at Massachusetts General Hospital in the US have developed a blood test which can predict an individual's risk of developing type 2 diabetes. The test measures the levels of...

Quincy Medical Starts Colon Cancer Device Trial
22 March 2011 Quincy Medical Center in the US has started a clinical trial to evaluate the Third Eye Retroscope, a device designed to detect colon cancer during colonoscopies. The Third Eye, developed...

Genomic Breast Cancer Test Shows Positive Results
22 March 2011 Genomic Health has announced positive results from nine studies using the Oncotype DX test in patients with early-stage breast cancer. The Oncotype DX breast cancer test analyses the...

Computer Software Could Help Diagnose Skin Infections
21 March 2011 Technology can help prevent misdiagnoses of skin infections, according to a study published in Dermatology Online Journal. In the study, a piece of software — VisualDx — designed...

Light Therapy May Improve Cognitive Function in Brain Injury Patients
21 March 2011 The application of light therapy via LEDs on the forehead and scalp can improve cognitive function and post-traumatic stress disorder in patients with a traumatic brain injury, a study published...

Hydro-Stomach CT Unreliable For Detecting Gastric Cancer
21 March 2011 Hydro-stomach CT imaging is not a reliable tool for the detection of early gastric cancer, a study published in World Journal of Gastroenterology has reported. The study evaluated whether...

FDA Approves Bayer MRI Contrast Agent
21 March 2011 The US Food and Drug Administration (FDA) has approved Gadavist (gadobutrol), a gadolinium-based contrast agent, for use in patients undergoing an MRI of the central nervous system. ...

Photodynamic Device Developed to Treat Precancerous Cervical Lesions
18 March 2011 Researchers at Photocure and Sagentia are developing non-surgical, tissue-preserving device which uses photodynamic therapy to treat human papillomavirus and the precursors of cervical...

Researchers Develop Blood Analysis Chip
18 March 2011 Researchers at the University of California in the US, Dublin City University in Ireland and Universidad de Valparaíso in Chile have developed a blood analysis chip that could help to...

UK MHRA Issues Warning Over Covidien Laparoscopic Device
18 March 2011 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning over Covidien's Ligasure blunt-tip laparoscopic sealer/divider, stating that the device may malfunction...

Advanced Cardiac Enrols Patients in Cardiac Ablation Catheter Study
18 March 2011 Advanced Cardiac Therapeutics has enrolled the first patients in a first-in-man CE mark clinical trial to evaluate the safety and performance of the company's Tempasure cardiac ablation catheter. ...

Corindus Begins Coronary Device Study
17 March 2011 Corindus Vascular Robotics has initiated a clinical trial of its CorPath 200 System, which offers interventional cardiologists complete percutaneous coronary intervention procedure control from...

HPV Home Tests Could Improve Cervical Screening Rates, Study Suggests
17 March 2011 Home tests for the human papillomavirus (HPV) could improve cervical screening uptake among women who do not respond to screening invitations, according to research published in the British...

Elana Receives FDA Clearance for Anastomosis Device
17 March 2011 The US Food and Drug Administration (FDA) has approved the excimer laser assisted non-occlusive anastamosis (ELANA) surgical kit, which allows neurosurgeons to re-route blood flow around...

New Blood-Glucose Testing Device Could Help Diabetics
17 March 2011 Engineers at Arizona State University and clinicians at Mayo Clinic in Arizona, US, have developed a painless self-monitoring blood-glucose sensor for patients with diabetes. The sensor...

Japanese Quake Could Disrupt Medical Device Sales
16 March 2011 US medical device makers could face disruptions to their sales following the earthquake and tsunami that hit Japan last week, Deutsche Bank has warned. Edwards Lifesciences Corporation,...

Neuronetrix Develops Device to Identify Alzheimer's
16 March 2011 Researchers at Neuronetrix have developed a new hairnet device that can identify Alzheimer's disease by tracking brain waves. The device, known as the Cognition System, contains tiny...

Low-Radiation Scan Proven Effective in Ruling Out Heart Problems
16 March 2011 Prospectively gated CT scans are as effective as standard tests when it comes to ruling out heart problems, a study published in the Annals of Internal Medicine has reported. ...

Sonitus Receives CE Mark for Hearing Aid
16 March 2011 Sonitus Medical has received European CE mark approval for its SoundBite Hearing System, which enables people who are deaf in one ear to regain their spatial hearing ability. SoundBite,...

FDA Approves Teleflex Haemodialysis Catheter
15 March 2011 Teleflex has received approval from the US Food and Drug Administration (FDA) for its Arrow NextStep antegrade chronic haemodialysis catheter. The catheter is designed to attain...

US Researchers Develop Early Emphysema Blood Test
15 March 2011 Researchers at New York-Presbyterian Hospital's Weill Cornell Medical Center, US, have developed a blood test which can detect emphysema well before symptoms occur. The test measures the...

Competitive Technologies Enrols Patients in Pain Device Study
15 March 2011 Competitive Technologies has initiated patient enrolment in a Phase II study to evaluate its Calmare pain therapy device, which uses electronic nerve stimulation. The device uses...

American Medical Reports Positive Prolapse Repair Study Results
15 March 2011 American Medical Systems has reported positive results from a six-month, prospective and multi-centre study of the Elevate Anterior and Apical Prolapse Repair System. The study was...

New Technology Could Non-Invasively Monitor Glucose Levels
14 March 2011 Researchers at Freedom Meditech are developing devices that can non-invasively scan the eye to monitor glucose levels in people with diabetes. The devices are based optical polarimetry,...

Blood Test Could Predict Inherited Ovarian Cancer Risk
14 March 2011 Researchers at University of Washington in the US are developing a new gene-based blood test which can determine a woman's risk of inheriting ovarian cancer. The test looks at 22 genes...

BRICSS Coronary Stent Market to Reach $1.4bn by 2015
14 March 2011 The coronary stent market for Brazil, Russia, India, China, South Africa and South Korea (BRICSS) is estimated to reach $1.4bn by 2015, according to a report by Research and Markets. The...

Avinger Completes Patient Enrolment in Catheter Trial
14 March 2011 Avinger has completed patient enrolment in a clinical trial to evaluate its Wildcat Catheter, which is used in the treatment of peripheral artery disease. The prospective,...

US Researchers Develop Device to Capture Cancer Cells
11 March 2011 Researchers at University of California, Los Angeles (UCLA) in the US have developed a device based on Velcro-like nanoscale technology to identify and capture tumour cells circulating in...

New Test Effective in Identifying Common STI
11 March 2011 A new assay could provide an effective way of identifying Trichamonos vaginalis, a common sexually transmitted infection, a study carried out at Rhode Island Hospital in the US has...

MabCure Ovarian Cancer Test Effective, Study Reveals
11 March 2011 MabCure has reported positive results from a study evaluating its new ovarian cancer diagnostic blood test. The new test uses the company's proprietary ovarian cancer monoclonal antibodies...

DNA Repair Test Could Predict Recurring Bowel Cancer
11 March 2011 A routine DNA mismatch repair test can predict tumour recurrence after surgery in patients with bowel cancer, according a study published in the Journal of Clinical Oncology. The trial...

Breathe Technologies Receives FDA Approval for Ventilator
10 March 2011 Breathe Technologies has received approval from the US Food and Drug Administration or the use of the BT-V2S ventilator in the home setting. The BT-V2S ventilator, a 1lb portable...

MEMS Sensor Could Detect Early-Stage Atherosclerosis
10 March 2011 Researchers at the University of Southern California in the US have developed a microelectromechanical system (MEMS) thermal sensor that can identify atherosclerosis in its early stages. ...

MHRA Issues Warning Over Teleflex Tracheostomy Set
10 March 2011 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning over The Great Ormond Street GOS tracheostomy cannula set, stating that the tube is too straight due to...

Toenail Test Could Predict Lung Cancer Risk
10 March 2011 A nicotine toenail test can determine the individual's risk of lung cancer, a study carried out at the University of California, San Diego has suggested. Researchers at the US university...

Brain Scans used to Diagnose Alzheimer's in UK Trial
09 March 2011 A pilot clinical trial to identify whether brain scans could be used to identify Alzheimer's disease in its early stages has been initiated at Maudsley Hospital in South London, UK. In...

Researchers Develop Non-Invasive Down Syndrome Test
09 March 2011 A simple blood test to diagnose Down syndrome prenatally has been developed by scientists at the Cyprus Institute of Neurology and Genetics. The non-invasive test analyses the foetal DNA...

NASA Technology Used to Reduce Chemotherapy Side Effects
09 March 2011 A NASA technology has successfully reduced painful side-effects resulting from chemotherapy and radiation treatment in bone marrow and stem cell transplant patients. The technology, known...

Multifunctional Catheter Could Simplify Heart Surgery
09 March 2011 An interdisciplinary team including researchers from Northwestern University in the US has developed a multifunctional catheter that can simplify treatment for arrhythmia and other heart diseases....

SuperSonic Reports Positive Results from Ultrasound Study
08 March 2011 SuperSonic Imagine has reported positive results from a worldwide multicentre study evaluating the benefit of ShearWave Elastography when added to ultrasound for improved lesion classification. ...

Miracor Completes Coronary Artery Device Study
08 March 2011 Miracor Medical Systems has successfully completed the pilot study of its PICSO (pressure-controlled intermittent coronary sinus occlusion) system, which is designed to improve acute...

US Researchers Develop Breast Cancer Detection Device
08 March 2011 Researchers at Rensselaer Polytechnic Institute in the US have developed a device that can identify breast cancer and accurately differentiate between benign and malignant tumours. The...

UK Scientists Announce Breakthrough in Early Bowel Cancer Detection
08 March 2011 Scientists at Cancer Research UK have found that DNA methylation patterns, a key process in cell development, could accurately detect early bowel cancer. It is hoped that the discovery...

Calypte Reports Positive Results from HIV Test Studies
07 March 2011 Calypte Biomedical Corporation has announced that it has successfully completed internal studies of its Aware HIV-1/2 oral fluid rapid test. The trials were conducted at two sites, one...

TOF PET Scans Improve Cancer Detection
07 March 2011 The use of time-of-flight (TOF) PET scans can improve the cancer detection, a study published in The Journal of Nuclear Medicine has found. Unlike conventional PET scans, TOF PET scans...

Ventus Receives CE Mark for Sleep Apnoea Device
07 March 2011 Ventus Medical has received European CE mark approval for its Provent sleep apnoea therapy. The nasal device fits over both nostrils and uses a proprietary MicroValve design to create...

New CPR System Improves Survival Rates
07 March 2011 A new cardiopulmonary resuscitation (CPR) method can improve long-term survival rates with good brain function by 50%, according to a five-year clinical trial led by researchers at University...

Global Cardiac Rhythm Management Devices Market to Hit $22.3bn
04 March 2011 The global market for cardiac rhythm management devices is estimated to reach $22.3bn by 2015, growing at a compound annual growth rate (CAGR) of 9.3% between 2009 and 2015, according to a...

Health Diagnostic Laboratory and Gamma Therapeutics Develop Heart Attack Risk Test
04 March 2011 Health Diagnostic Laboratory has entered into a partnership with Gamma Therapeutics to further develop a novel test to help cardiologists determine heart attack and stroke risk. The test...

Heart Device Studies Exclude Women, Research Reveals
04 March 2011 Many heart device studies conducted to gain approval from the US Food and Drug Administration (FDA) do not include enough women, research reported in Circulation: Cardiovascular Quality...

Scientists Develop Test to Predict Neuropathy Risk from Bone Cancer Treatment
04 March 2011 Scientists at the Institute of Cancer Research in the UK have developed a genetic test that can predict whether bone cancer treatments are likely to cause neuropathy, a dangerous nerve disorder. ...

Blood Test Could Identify Heart Failure Relapse Risk
03 March 2011 A routine blood test could predict the likelihood of congestive heart failure in patients who have a high risk of relapse and readmission after being discharged from hospital, according to a...

Valeritas Insulin Device Receives FDA Approval for Use with NovoLog
03 March 2011 Valeritas has received 510(k) Clearance from the US Food and Drug Administration (FDA) for its V-Go disposable insulin delivery device, for use with Novo Nordisk's NovoLog. V-Go is...

Pathwork Reports Positive Results from Study to Determine Cancer Origin
03 March 2011 Pathwork Diagnostics has reported positive results from a study evaluating its Tissue of Origin Test, which is used to identify which tissue a cancer originated from. The FDA-approved Tissue...

UK Scientists Develop Prostate Cancer Test
03 March 2011 Scientists at the University of Surrey in the UK have developed a test that can diagnose prostate cancer from a urine sample. The test detects Engrailed-2 (EN2), a protein made by...

Biotronik Begins Intraoperative Defibrillator Testing Study
02 March 2011 Biotronik has initiated patient enrolment in a trial to investigate the use of intraoperative defibrillation testing during implantable cardioverter defibrillator (ICD) implantation. ...

MeadWestvaco Launches Preservative Free Pharmaceutical Spray Pump
02 March 2011 MeadWestvaco has announced the availability of its Preservative-Free Pump Topical (PFP T) for sampling. PFP T, which is specifically designed for topical applications, is the company's...

Medtronic Reports Positive Results from Heart Valve Study
02 March 2011 Medtronic has reported that its Mosaic bioprosthetic heart valve has demonstrated positive performance results after 12 years in a study published in The Journal of Thoracic and...

Epigenomics and Qiagen to Develop Colorectal Cancer Blood Test
02 March 2011 Epigenomics and Qiagen have entered into a partnership to develop and commercialise a colorectal cancer blood test. The test will be based on Epigenomics' proprietary mSEPT9 biomarker...

UK Researchers Develop Home Diabetes Test
01 March 2011 A research team at the Peninsula Medical School in the UK has developed a simple home urine test that can determine if patients with Type 1 and Type 2 diabetes are producing their own...

Portable Device Could Help Detect Cancer
01 March 2011 Researchers at Massachusetts General Hospital, US, have developed a portable device analyse tissue samples to determine if a cancer is malignant. The $200 device is designed to connect to...

NewCardio Reports Positive Cardiac Monitoring Device Study
01 March 2011 NewCardio has reported positive results from a clinical study evaluating CardioBip, a handheld device that provides ECG telemonitoring. The CardioBip can be carried by the patients and...

Opsens Completes Study of Coronary Artery Catheter
01 March 2011 Opsens has successfully completed a pre-clinical animal study of its EasyWire device, which is designed to measure fractional flow reserve in the evaluation of coronary lesions. EasyWire is...

February 2011

Top

HbA1c Test Not Effective for Diabetes Diagnosis in Children
28 February 2011 The haemoglobin A1c (HbA1c) test is not effective when it comes to diagnosing diabetes in children, according to a study by University of Michigan's CS Mott Children's Hospital in the US. ...

FDA Permits Marketing of First Preliminary Norovirus Test
28 February 2011 The US Food and Drug Administration (FDA) has permitted the marketing of the Ridascreen norovirus 3rd generation EIA assay, the first test for the preliminary identification of norovirus. ...

Researchers Develop Blood Test for Bladder Cancer
28 February 2011 Researchers at Brown University in the US have developed a blood test that can predict and detect bladder cancer. The test measures a pattern of methylation, a chemical alteration to DNA...

Laser-Based Tool Developed to Diagnose Skin Cancer
28 February 2011 Researchers at Duke University in the US have developed a laser-based tool that can produce high-resolution images to help doctors diagnose melanomas. The tool uses two lasers to pump...

Annual Mammograms Help Detect Second Breast Cancers Early
25 February 2011 Annual mammograms help to detect second breast cancers early, according to a study conducted by the Breast Cancer Surveillance Consortium. Researchers examined 12 years of data from...

New Test Could Predict Infant Autism Risk
25 February 2011 Researchers at Children's Hospital Boston in the US are developing a non-invasive test that analyses electrical activity in the brain to evaluate an infant's risk of developing autism. The...

Biomoda Completes Patient Enrolment for Lung Cancer Test
25 February 2011 Biomoda has completed patient enrolment and sample collection for a pilot study to determine the clinical sensitivity and specificity of its CyPath diagnostic assay for the early detection of...

European Minimally Invasive Spinal Implant Market to Exceed €90m by 2017
25 February 2011 The European market for minimally invasive spinal (MIS) implants is estimated to exceed €90m by 2017, according to a new report by Research and Markets. Rapid growth of MIS interbody...

Balloon Kyphoplasty Improves Survival Rates in Spinal Fracture Patients
24 February 2011 Patients over 65 who have had spinal fractures treated with minimally invasive surgery have higher survival rates up to four years after treatment than patients who are not operated on,...

Surgeons Test Device to Treat Diabetes and Obesity
24 February 2011 Surgeons at Southampton General Hospital in the UK have performed 15 implants of a new device known as EndoBarrier to treat type II diabetes and obesity. Endobarrier is a small plastic...

W L Gore Receives CE Mark for Haemodialysis Vascular Graft
24 February 2011 W L Gore & Associates has received the European CE mark for its Gore Propaten Vascular Graft for haemodialysis. Arteriovenous grafts are used to create a conduit for repeated blood...

Researchers Identify New Marker for Heart Disease
24 February 2011 Researchers at the University of Calgary in Canada have identified a new marker that could predict an individual's risk of developing coronary heart disease. The research found that...

Fresenius Receives FDA Approval for Home Dialysis Machine
23 February 2011 Fresenius Medical Care has received approval from the US Food and Drug Administration (FDA) for 2008K@home haemodialysis device. The 2008K@home contains a simple interface and other...

New Device Looks Under Skin to Detect Cancer
23 February 2011 Researchers at the University of Rochester in the US have developed an optical technology that can image under the skin's surface, enabling the doctors to determine if skin lesions are benign...

New Device Can Accurately Measure Aortic Blood Pressure
23 February 2011 Researchers at University of Leicester in the UK have developed a new device to accurately measure blood pressure. Unlike the traditional methods, the new device measures blood pressure in...

Researchers Develop Specific Tuberculosis Test
23 February 2011 Researchers have developed a diagnostic tool that allows the sensitive and highly specific identification of patients with active tuberculosis. To develop the assay, researchers...

Study Shows Long-Term Benefit of Total Knee Replacement
22 February 2011 Total knee replacement can help patients to maintain remarkable functional capacity and activity levels even after 20 years, according to a study conducted at the Center for Hip and Knee Surgery...

Micell Initiates Patient Enrolment in Coronary Stent Study
22 February 2011 Micell Technologies has enrolled the first patient in a clinical trial evaluating the company's MiStent drug-eluting coronary stent system. The trial is being conducted to support CE...

Integra and Stout Medical to Develop Expandable Interbody Device
22 February 2011 Integra LifeSciences Holdings has entered into an exclusive worldwide licence and development agreement with Stout Medical Group to develop and commercialise an expandable interbody device. ...

Intrinsic Begins Patient Enrolment in Anular Closure Device Study
22 February 2011 Intrinsic Therapeutics has enrolled the first patient in a trial to evaluate Barricaid, an anular closure device designed to prevent reherniations following lumbar discectomy. The device...

Medtronic Reports Positive Results from Spinal Device Study
21 February 2011 Medtronic has reported positive results from a study comparing Kyphon balloon kyphoplasty with non-surgical care to treat spinal fractures in cancer patients. The trial results showed...

Xbox Robots to Diagnose Mental Disorders In Children
21 February 2011 Researchers at the University of Minnesota, US, are developing robotic devices and computer vision algorithms that will help identify children at risk of developing mental disorders. ...

Ultrasound Fusion Imaging Helps Tumour Biopsy
21 February 2011 Biopsies using ultrasound fusion imaging to identify bone and soft tissue cancers are safe, effective and as accurate as conventional biopsy methods, according to a new study from Henry...

FDA Approves Expanded Use of Allergan Lap-Band System
21 February 2011 The US Food and Drug Administration (FDA) has approved the expanded use of the Allergan lap-band system, a device for the treatment of obesity. With the new approval, the lap-band...

Endosense Completes Patient Enrolment in Catheter Trial
18 February 2011 Endosense has completed patient enrolment in the Efficas I clinical study to evaluate TactiCath, a force-sensing catheter for the treatment of atrial fibrillation and supraventricular tachycardia....

Venous Receives FDA Approval for Vascular Insufficiency Device
18 February 2011 Venous Health Systems has received 510(k) approval from the US Food and Drug Administration (FDA) for its Vasculaire Compression System, a portable pneumatic device to treat vascular...

Yale University Researchers Develop Turner Syndrome Test
18 February 2011 Researchers at Yale University in the US have developed an accurate diagnostic test for Turner syndrome, a genetic defect that obstructs normal growth and leads to cardiac and renal...

Hip and Thigh Implants Increase Fracture Risk in Children
18 February 2011 Children with hip and thigh implants designed to help heal a broken bone or correct other bone conditions are at high risk of subsequent fractures, according to research from Johns...

FDA Reclassifies Medical Device Data Systems
17 February 2011 The US Food and Drug Administration (FDA) has announced a final rule offering a less-burdensome path for market certain hardware and software products used in conjunction with medical...

Nfocus Receives CE Mark for Brain Aneurysm Device
17 February 2011 Nfocus Neuromedical has received the European CE mark for its Luna aneurysm embolisation system, which is indicated for the treatment of patients with brain aneurysms. The Luna...

MRI Helps Detect Breast Cancer in Women with Radiation History
17 February 2011 MRI can detect invasive breast cancers missed by mammography in women who have undergone chest irradiation for other diseases, a study published in Radiology has reported. Women who...

Endologix Reports Positive Results from Aortic Aneurysm Study
17 February 2011 Endologix has reported positive initial clinical results from a trial evaluating the IntuiTrak System and Abbott's Prostar XL closure device for the endovascular repair of abdominal...

U-Systems Completes Automated Breast Ultrasound Study
16 February 2011 U-Systems has completed a study evaluating the sensitivity of its somov automated breast ultrasound (ABUS) for the detection of breast cancer in women with dense breast tissue. The study...

UT Southwestern Scientists Develop Alzheimer's Test
16 February 2011 Scientists at UT Southwestern Medical Center in the US have developed a novel blood test to identify Alzheimer's disease long before symptoms appear. The test uses synthetic peptoids...

BioSurface Initiates Bone Graft Substitute Study
16 February 2011 BioSurface Engineering Technologies has initiated a pilot clinical study in Canada to evaluate the effectiveness of Amplex, a bone graft substitute for foot and ankle fusion surgery. ...

FDA 510(k) Process Linked to High-Risk Device Recalls
16 February 2011 Most medical devices that have been recently recalled by the US Food and Drug Administration (FDA) were initially approved through the expedited 510(k) process, according to a study published...

Aperion Initiates Knee Reconstruction Device Trial
15 February 2011 Aperion Biologics has enrolled and treated the first patients in a trial to evaluate its Z-Lig anterior cruciate ligament reconstruction device, which is used to treat knee ligament...

Researchers Develop Non-Invasive Melanoma Test
15 February 2011 Researchers at US-based DermTech International have developed a non-invasive test that uses special adhesive tape to collect cells from suspicious skin lesions to identify advanced...

Scientists Discover Gene Behind Congenital Myasthenic Syndrome Variant
15 February 2011 Scientists at Newcastle University in the UK have identified a gene that could improve the diagnosis of a variation of congenital myasthenic syndrome, an inherited neuromuscular disorder. ...

FDA Clears First 3D Mammography Imaging System
15 February 2011 Hologic has received US Food and Drug Administration (FDA) approval for the Selenia Dimensions System, the first X-ray mammography device to provide 3D images of the breast. The...

Researchers Develop Device to Simplify Cardiac Surgery
14 February 2011 Researchers at Georgia Institute of Technology in the US have developed a system to simplify the technique of opening and closing a beating heart during cardiac surgery. The system is...

Cytomedix Receives CE Mark for Blood-Separating Systems
14 February 2011 Cytomedix has received European CE mark approval for its Angel whole-blood separation system and its activAT autologous thrombin processing kit. Angel consists of a blood-processing device...

MRI Helpful in Deciding Therapy for Stroke Patients, Study Suggests
14 February 2011 MRI scans can help to identify stroke patients who will benefit from clot-busting drugs, a study conducted at the University of Ulsan College of Medicine in South Korea has found. ...

Concentric Initiates Patient Enrolment for Clot Retrieval Device
14 February 2011 Concentric Medical has enrolled the first patients in a clinical trial to evaluate the Trevo Retriever, a device to retrieve clots from ischemic stroke patients. The Trevo Retriever...

Wireless Device Could Reduce Heart Failure Hospitalisations
11 February 2011 An implantable device that monitors fluid build up in the lungs of heart failure patients and alerts doctors when intervention is needed can significantly reduce hospitalisations, according to...

Handheld Sensor Could Detect Impending Asthma Attacks
11 February 2011 Researchers have developed a handheld sensor that can detect impending asthma attacks hours in advance, potentially allowing patients to take preventive measures. The Siemens device, which...

FDA Unveils Medical Device Innovation Initiative
11 February 2011 The US Food and Drug Administration (FDA) has proposed a new innovation pathway to serve as a priority review programme to speed up the adoption of breakthrough medical devices. The...

US Interventional Ophthalmic Device Market to Reach $2bn by 2017
11 February 2011 The US interventional ophthalmic device market is estimated to reach nearly $2bn by 2017, according to a report by Research and Markets. Intraocular lenses, which consist of multifocal...

CSEM and Nano-Retina to Develop Sight-Restoring Chip
10 February 2011 CSEM and Nano-Retina are jointly working on an implantable bionic chip to restore the eyesight of people who have been blinded by degenerative retinal diseases. The chip, which will...

Gene Test Could Predict Prostate Cancer Aggressiveness
10 February 2011 Researchers are developing a genetic test to predict prostate cancer aggressiveness, which could save men with low-risk tumours from unnecessary surgery. Researchers at Queen Mary,...

Researchers Develop Device to Limit Chemotherapy Side Effects
10 February 2011 Researchers have developed a device that can limit the side effects of chemotherapy. The device uses tiny amounts of palladium to trigger reactions in cells, allowing the cancer drugs to...

Medtronic Receives FDA Approval for MRI-Safe Pacemaker
10 February 2011 Medtronic has received approval from the US Food and Drug Administration (FDA) for its Revo MRI SureScan pacing system, the first pacemaker that can be safely scanned by MRI. Patients who...

FDA Orders TMJ Implant Manufacturers to Conduct Post-Market Surveillance
09 February 2011 The US Food and Drug Administration (FDA) has ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct post-market surveillance studies due to the high rate of...

BD to Acquire Accuri Cytometers
09 February 2011 BD has signed a definitive agreement to acquire Accuri Cytometers. Accuri Cytometers is a US-based company that develops and manufactures personal flow cytometers, which are devices used...

MHRA Warns of Roche Blood-Glucose Meter Risk
09 February 2011 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning over professional blood-glucose meters manufactured by Roche Diagnostics, saying that the meters may give...

Study Shows Women Benefit More from CRT-D Devices
09 February 2011 Women given cardiac resynchronisation therapy with a defibrillator (CRT-D) are less likely to suffer heart failure than men, a study published in the Journal of the American College of...

Optical Device Could Let Diabetics Measure Blood-Sugar With Eye Scans
08 February 2011 Researchers at UK-based Lein Applied Diagnostics are developing an optical device that can read blood-sugar levels by scanning the eye. The device shines light into the eye and interprets...

Mayo Researchers Develop Device to Measure Brain Serotonin Levels
08 February 2011 Researchers at the Mayo Clinic in the US have developed a device that can measure serotonin levels in the brain. The Wireless Instantaneous Neurotransmitter Concentration System (WINCS)...

Stem Cell Spray Could Help Burn Victims Regrow Skin
08 February 2011 Researchers at the University of Pittsburgh in the US have developed a device to sprays stem cells onto burned skin, allowing healthy skin to regrow. The stem cells used are taken from...

FDA Approves First Mobile Radiology Application
08 February 2011 The US Food and Drug Administration (FDA) has approved a mobile radiology application that allows physicians to view medical images on Apple's iPhone and iPad devices. This application,...

ConforMIS Receives FDA Clearance for Knee Replacement System
07 February 2011 ConforMIS has received 510(k) clearance from the US Food and Drug Administration (FDA) for its iTotal CR knee replacement system. iTotal CR is the first patient-specific system to be...

Scientists to Develop Non-Invasive Acetone Test for Diabetes
07 February 2011 Scientists at Oxford Medical Diagnostics are developing a device that allows people with diabetes to monitor their condition without finger-prick testing. The device will measure the levels...

Cepheid and FIND to Collaborate HIV Viral Load Test
07 February 2011 Cepheid and the Foundation for Innovative New Diagnostics (FIND) have entered into a partnership to accelerate the development of a rapid molecular test to measure HIV viral load. The Xpert...

Global X-Ray Systems Market to Reach $4.8bn by 2016
07 February 2011 The global X-ray systems market is estimated to reach $4.8bn by 2016, according to a report by Research and Markets. The market is expected to have a compound annual growth rate (CAGR) of...

Researchers Develop Seizure-Detecting Device
04 February 2011 A watch-like device that can detect the occurrence of seizures and immediately alert a patient's caregiver has been developed by researchers at SmartMonitor. The SmartWatch can be worn on...

UK Scientists Develop Blood Test for vCJD
04 February 2011 Scientists in the UK have developed a prototype blood test for variant Creutzfeldt–Jakob disease (vCJD), the human form of mad cow disease, which is 100,000 times more sensitive than any...

Flexible Stenting Solutions to Begin Femoropopliteal Stent Trial
04 February 2011 Flexible Stenting Solutions is planning to begin a clinical trial of its FlexStent Femoropopliteal self-expanding stent system, following investigational device exemption approval by the US...

Molecular Markers Could Predict Prostate Cancer Aggressiveness
04 February 2011 Researchers at Dana-Farber Cancer Institute in the US have identified a signature of four molecular markers that can be used to predict if an existing prostate cancer is likely to remain dormant...

Repeat MRIs for Breast Cancer Leads to Fewer False Positives
03 February 2011 Repeat MRI screenings for breast cancer are associated with fewer false positive results, a study published in the Radiology has found. The study was designed to determine if the...

Cyberonics Receives FDA Approval for Vagus Nerve Stimulation Device
03 February 2011 Cyberonics has received approval from the US Food and Drug Administration (FDA) for the AspireHC generator for use in vagus nerve stimulation therapy. The system, which uses an...

US Researchers Develop Tumour-Tracking Technique
03 February 2011 Researchers at Thomas Jefferson University and Jefferson's Kimmel Cancer Center in the US have developed a robotic tumour-tracking technique that could improve cancer treatment. The 4D...

New Laser Technology Could Lead to Pain-Free Cancer Biopsies
03 February 2011 New laser technology that could take the pain out of cancer biopsies has been developed by researchers at Michigan State University, US. The technology uses laser microscopes that...

Cappella Begins Coronary Artery Stent Study
02 February 2011 Cappella Medical Devices has initiated patient enrolment in a multi-centre, open-label study in Italy to evaluate the Sideguard stent for the treatment of coronary artery disease. The...

New Optical Device Could Help in Tumour Resection
02 February 2011 A newly developed optical touch pointer can be used to differentiate healthy tissues from tumours and help surgeons during the resection of malignant brain tumours, a study published in the...

hTERT Analysis Can Provide Lung Cancer Prognosis
02 February 2011 Human telomerase reverse transcriptase (hTERT) analysis can be used as a prognostic tool to predict lung cancer progression, a study published in the Journal of Thoracic Oncology has found. ...

3D X-Rays in Orthodontic Diagnosis Increase Radiation Exposure
02 February 2011 The use of 3D X-rays in orthodontic cases may expose patients to unnecessary radiation that could be avoided by using 2D X-rays, a study published in Dentomaxillofacial Radiology has...

Medical Device Recall Rates Similar in US and Europe
01 February 2011 Medical device recalls in the US and Europe occur at a similar rate, even though the approval process in the US takes significantly longer, according to a report released by the Advanced...

Sorin Receives CE Mark for Aortic Heart Valve
01 February 2011 Sorin Group has received European CE Mark approval for Perceval S, its surgical self-anchoring aortic heart valve. Perceval S is indicated for the rapid and minimally invasive...

Artificial Pancreas Could Help Pregnant Diabetics
01 February 2011 A wearable artificial pancreas could control type 1 diabetes during pregnancy, according to a study conducted by researchers at Cambridge University in the UK. Researchers tested the...

Contrast-Enhanced Ultrasound Could Improve Paediatric Diagnosis
01 February 2011 Contrast-enhanced ultrasound can safely improve the diagnosis of a variety of medical conditions in children, according to a study by researchers at Jena University Hospital, Germany. In...

January 2011

Top

Sonitus Receives FDA Clearance for Hearing Aid
31 January 2011 Sonitus Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for the SoundBite Hearing System, a non-surgical hearing prosthetic to treat single-sided...

PDAs Help Doctors to Understand Fibromyalgia Pain
31 January 2011 Using a PDA to record daily fibromyalgia symptoms can help patients and doctors to better understand the links between pain, emotional distress and fatigue, a study published in the Journal of...

US Sues Boston Scientific Over Defective Heart Devices
31 January 2011 The US Justice Department has sued Boston Scientific Corporation and Guidant, a unit of Boston Scientific, for selling defective heart devices that were then implanted in Medicare...

New Filtration System Could Help to Capture Cancer Cells
31 January 2011 Researchers at the Georgia Institute of Technology in the US are developing a filtration system that uses magnetic nanoparticles to capture cancer cells. The procedure requires fluids to...

Boston Scientific Begins Patient Enrolment in Coronary Stent Study
28 January 2011 Boston Scientific Corporation has initiated patient enrolment for a clinical trial to assess its Promus Element everolimus-eluting coronary stent system. The study is designed to evaluate...

FDA Warns of Breast Implant Cancer Link
28 January 2011 The US Food and Drug Administration (FDA) has reported a possible link between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma, a rare type of cancer. ...

Researchers Develop Paper Strips for Rapid Medical Diagnosis
28 January 2011 Researchers at Purdue University in the US have developed paper strips that can be used with electronic readers to diagnose diseases. The modified surface of the paper, which contains...

IVAX Receives FDA Approval for Autoimmune Disease Test
28 January 2011 IVAX Diagnostics has received 510(k) approval from the US Food and Drug Administration for Mago 4S, a fully automated system to test for autoimmune and infectious diseases. Mago 4S...

Taiwanese University Develops Prototype Cancer Treatment System
27 January 2011 Researchers at National Cheng Kung University in Taiwan have developed a prototype system to treat cancer without chemotherapy or laser surgery. The prototype includes a...

New Instrument Provides Force Feedback in Keyhole Surgery
27 January 2011 A keyhole surgery instrument that gives physical feedback based on the amount of grasp force being applied has been developed at Delft University of Technology in the Netherlands. ...

Deep Brain Stimulation Could Decrease High Blood Pressure
27 January 2011 Deep brain stimulation could be used to treat high blood pressure in patients who do not respond to drugs, a study conducted at the University of Bristol and Frenchay Hospital in the UK has found....

Inappropriate ICD Shocks Increase Mortality Risk
27 January 2011 Implantable cardioverter-defibrillators (ICDs) designed to stop dangerous heart rhythms can produce inappropriate shocks, thereby increasing the risk death, researchers from Leiden...

US Universities to Conduct Study on Heart Device Implantation
26 January 2011 The University of Michigan Cardiovascular Center and the University of Pittsburgh have announced that they will conduct a study to evaluate the benefits of earlier implantation of left...

Biomerix Receives CE Mark for Soft Tissue Repair Mesh
26 January 2011 Biomerix Corporation has received European CE mark approval for its Revive soft tissue repair mesh. The biointegrative synthetic tissue scaffold is designed for repair and reinforcement in...

Boston Scientific Completes Patient Enrolment for Coronary Stent Trial
26 January 2011 Boston Scientific Corporation has completed patient enrolment for a clinical trial to evaluate the safety and performance of its fourth-generation Synergy coronary stent. The...

DNA Methylation Test Can Help in Earlier Melanoma Diagnosis
26 January 2011 A test for DNA methylation could allow doctors to diagnose melanoma earlier and more precisely, according to a study conducted at the University of North Carolina, US. Researchers...

Study Finds CT Scanning Improves Abdominal Pain Diagnosis
25 January 2011 Using CT scanning to assess abdominal pain in the emergency departments can help physicians arrive at a diagnosis quickly and decisively, according to a study conducted at Massachusetts...

On-X Life Aortic Valve Receives FDA Approval
25 January 2011 On-X Life Technologies has received approval from the US Food and Drug Administration (FDA) to market its On-X Ascending Aortic Prosthesis (AAP) with the Vascutek Gelweave Valsalva graft. ...

Everist Reports Results of Colorectal Cancer Recurrence Test Study
25 January 2011 Everist Genomics has reported positive results from the external validation study of OncoDefender-CRC, its colorectal cancer recurrence test. The study, conducted by Mayo Validation...

Researchers Develop Infant Ear Correction Device
25 January 2011 Researchers at the University of Texas Southwestern Medical Center in the US have developed a plastic moulding device that can non-invasively reshape prominent or misfolded ears in newborn babies....

MHRA Issues Warning Over Oxford Weigh Scales
24 January 2011 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert regarding Oxford patient hoist weigh scales, warning that there is a risk that the scales...

Boston Scientific to Acquire Atritech
24 January 2011 Boston Scientific Corporation has signed a definitive merger agreement to acquire Atritech. Atritech will receive an upfront payment of $100m and potential payments up to $275m depending...

Genetic Test and fMRI May Predict Cognitive Decline
24 January 2011 Combining the APOE e4 allele genetic blood test with functional MRI (fMRI) can successfully predict cognitive decline in healthy adults, according to a study conducted at Wayne State...

FDA to Improve 510(k) Approval Process
24 January 2011 The US Food and Drug Administration (FDA) has published a plan containing 25 actions intended to improve the 510(k) process – the most common review path for medical devices – by 2011. ...

Drug-Coated Stents Help Treat Blocked Leg Arteries
21 January 2011 Drug-coated stents are effective for treating blocked leg arteries, according to results from a two-year follow up study evaluating the Zilver PTX (paclitaxel-coated) stent. The...

PositiveID Develops Temperature Sensing Microchip
21 January 2011 PositiveID Corporation, in collaboration with RFID Solutions, has developed a temperature sensing microchip for use in humans. The microchip, which uses radio frequency...

UK MHRA Issues Warning Over Counterfeit Covidien Sensors
21 January 2011 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a device alert warning that counterfeit Covidien Nellcor SpO2 Durasensors (DS-100A) may have been supplied to...

Researchers Develop Imaging Procedure to Diagnose Alzheimer's
21 January 2011 A new type of molecular imaging procedure may be capable of detecting the presence of beta-amyloid, a protein linked to Alzheimer's disease, according to preliminary research conducted by...

AdvanDx Receives FDA Clearance for Bloodstream Infection Test
20 January 2011 AdvanDx has received 510(k) clearance from the US Food and Drug Administration (FDA) for its GNR Traffic Light PNA FISH test, which is used to identify Escherichia coli, Klebsiella pneumoniae...

Stents Shown to be Effective in Opening Blocked Brain Arteries
20 January 2011 Stents can be used to open blocked brain arteries when other stroke treatments fail, a study conducted at the Baptist Cardiac & Vascular Institute in the US has found. In the study,...

Scientists Develop Technique to Examine Deep Brain Neurons
20 January 2011 Scientists at Stanford University have developed a technique that allows researchers to examine the neurons of the deep brain for months at a time. The method involves tiny glass tubes,...

US Orthopaedic Extremity Device Market to Reach $4.6bn by 2015
20 January 2011 The US orthopaedic extremity device market is estimated to generate over $4.6bn in revenues by 2015, growing at a compound annual growth rate of 10%, according to a report by Millennium...

Cook Peripheral Stent Shows Sustained Primary Patency in Study
19 January 2011 Cook Medical has reported positive follow-up study results of its investigational drug-eluting stent, indicated for the treatment of peripheral arterial disease in the superficial femoral artery. ...

Ultrasound Helps to Treat Pulmonary Embolisms, Study Finds
19 January 2011 A tiny ultrasound device may be helpful in the treatment of pulmonary embolisms – blockages of blood vessels in the lungs – according to a study conducted at East Jefferson General Hospital...

Thermometer Could Reduce Diabetic Foot Ulcers
19 January 2011 Researchers at Diabetica Solutions have developed a handheld device that can reduce the number of ulcers, infections and limb amputations in people with diabetes. The...

First Endovascular Pulmonary Embolism Device Approved
19 January 2011 Ekos Corporation has been given the European CE mark for its EkoSonic Endovascular System for the treatment of pulmonary embolism, making it the first endovascular device approved to treat...

Blood-Sugar Meters Found to be Inaccurate When Used During Pregnancy
18 January 2011 Readings from blood-sugar meters can vary by as much as 16% when used by pregnant women, a study has found. In the study, conducted by Royal Prince Alfred Hospital in Australia,...

Henry Ford Health System Launches Study to Develop Pancreatic Cancer Test
18 January 2011 The Henry Ford Health System and the Barbara Ann Karmanos Cancer Institute have launched a clinical research study to develop a rapid and inexpensive blood test for the early diagnosis...

Nanosphere Receives FDA Clearance for Respiratory Virus Test
18 January 2011 Nanosphere has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System. In a single...

US Marshals Seize Dental Products from Rite-Dent
18 January 2011 US Marshals have seized all dental devices from Florida-based Rite-Dent Manufacturing Corporation, after its manufacturing facility was found to have significant deficiencies. The move...

Zoll Completes Cardiac Life-Support Pump Trial
17 January 2011 Zoll Medical Corporation has reported the successful completion of a trial evaluating AutoPulse, its non-invasive cardiac life-support pump. The trial's data safety monitoring board...

European Abdominal Aortic Stent Graft Market to Reach $300m by 2015
17 January 2011 The abdominal aortic stent graft market in Europe is estimated to reach $300m by 2015, according to a report by the Millennium Research Group. The report says that the market will be driven...

Researchers Develop Neonatal Test for Tyrosinaemia Type I
17 January 2011 Meyer Children's Hospital of Florence and PerkinElmer have developed an early stage neonatal diagnostic test for Tyrosinaemia Type I, a rare metabolic genetic disorder which can lead to death...

Dance Pharma and Aerogen to Develop Inhaled Insulin Device
17 January 2011 Dance Pharma and Aerogen are planning to develop an inhaled insulin device based on Aerogen's proprietary OnQ Aerosol Generator technology. Under the agreement, Aerogen has granted Dance...

Endosense Begins Patient Enrolment for Atrial Fibrillation Catheter Trial
14 January 2011 Endosense has initiated patient enrolment for a clinical study to evaluate the TactiCath1 force-sensing ablation catheter as a treatment for symptomatic paroxysmal atrial fibrillation. ...

PakSense Launches Temperature Monitoring Device
14 January 2011 PakSense has launched BIOmed Label, a new class of temperature monitoring device for use in clinical trial, pharmaceutical, biologic, vaccine and other healthcare-related material...

OrbusNeich Stent Demonstrates Good Clinical Outcomes
14 January 2011 High-risk patients who cannot be treated with drug eluting stents and accompanying dual antiplatelet therapy can be treated with OrbusNeich's Genous stent, according to a study published...

IntraPace Receives CE Mark Approval for Obesity Device
14 January 2011 IntraPace has received European CE mark approval for its abiliti system as a treatment for obesity. The implantable device looks similar to a pacemaker and is implanted in a simple...

Takeda and Zinfandel to Develop Test to Identify Alzheimer's Risk
13 January 2011 Takeda Pharmaceutical Company and Zinfandel Pharmaceuticals have entered into a worldwide licensing agreement to develop the Zinfandel TOMM40 assay, a biomarker in development to detect the risk...

New Scanner Can Detect Live Cellular Processes
13 January 2011 Researchers at Universidad Carlos III de Madrid (UC3M) in Spain have designed and developed a biomedical scanner that can determine if a body organ is malfunctioning before an anatomical...

Nfocus Vessel Occlusion System Receives FDA 510(k) Clearance
13 January 2011 Nfocus Neuromedical has received US Food and Drug Administration (FDA) 510(k) clearance for its Acta vessel occlusion system (VOS), which is used to treat vascular lesions. The Acta VOS...

Down's Syndrome Blood Test Could Reduce Miscarriage Risk
13 January 2011 A DNA blood test that can identify if an unborn child has Down's syndrome could eliminate the need for invasive procedures such as amniocentesis, according to a study published in the...

Global Endoscopy Devices Market to Exceed $6.5bn by 2016
12 January 2011 The global market for endoscopy devices is estimated to exceed $6.5bn by 2016, according to a report by Research and Markets. The market, forecast to have a compound annual growth rate of...

Scientists to Develop Device to Prevent Radiotherapy Errors
12 January 2011 A device to reduce the risk of radiotherapy mistreatment is being developed by scientists at the University of Bristol, Swansea University and the Bristol Haematology and Oncology Centre. ...

Boston Scientific Completes Iliac Stent Trial Patient Enrolment
12 January 2011 Boston Scientific Corporation has completed patient enrolment for a clinical trial designed to evaluate its EPIC self-expanding nitinol stent system for the treatment of iliac artery...

OPKO and Bristol-Myers to Develop Alzheimer's Blood Test
12 January 2011 OPKO Health has entered into a collaboration agreement with Bristol-Myers Squibb to develop a blood test for Alzheimer's disease. The two companies will examine the use of OPKO's...

FDA Approves Automated Cardiovascular Test
11 January 2011 diaDexus has received approval from the US Food and Drug Administration (FDA) for automated version of its proprietary PLAC Test. The cardiovascular test is used to evaluate a patient's risk...

US Researchers Develop Lab-on-a-Chip Blood Test
11 January 2011 Researchers at the University of Rhode Island, US, have developed a lab-on-a-chip blood-testing device that can provide results in less than 30 minutes. A drop of blood is placed on a...

Hologic Acquires Interlace Medical
11 January 2011 Hologic has acquired Interlace Medical for $125m. Following the transaction, Interlace's operations will be integrated within Hologic's GYN Surgical Products division. The value of...

Researchers Develop Prototype Device to Eliminate Dental Drill Noise
11 January 2011 A device that cancels out the noise made by a dental drill has been developed by researchers from three universities in the UK. The device, developed by King's College London, Brunel...

STI Capital Acquires Cardionetics
10 January 2011 STI Capital, a division of contract electronics manufacturer STI, has acquired Cardionetics, which specialises in the manufacture of handheld ECG devices for use by general...

Gynesonics Receives CE Mark for Uterine Fibroids Device
10 January 2011 Gynesonics has received the CE mark for its VizAblate system, a transcervical device for the treatment of uterine fibroids. The VizAblate system combines ultrasound image guidance...

UK MHRA Issues Unomedical Feeding Tube Warning
10 January 2011 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning over Unomedical's Nasogastric feeding tube, stating that the tube's luer lock may crack due to a...

Haemoglobin A1c Test Can Identify Pre-Diabetes
10 January 2011 A common blood test known as haemoglobin A1c can accurately identify whether an individual is predisposed to diabetes, a study published in the American Journal of Preventive Medicine has found. ...

Pico-Tesla Initiates Alzheimer's Device Trial
07 January 2011 Pico-Tesla has initiated a pilot study of its Resonator system in 30 patients with Alzheimer's disease symptoms. The randomised, double-blind and placebo-controlled pilot study will evaluate...

New Device Could Identify Pre-Cancerous Oesophagus Cells
07 January 2011 Biomedical engineers at Duke University, US, have developed a non-invasive device that can identify Barrett's oesophagus as well as precancerous cells in the oesophagus. The device, which...

Global Market for ECG Telemetry Devices to Reach $1.1bn by 2015
07 January 2011 The global market for ECG telemetry devices is estimated to reach $1.1bn by 2015, according to a report by Global Industry Analysts. The market will be driven by increasing cases...

New Test Could Predict Efficiency of Hepatitis C Infection Treatments
07 January 2011 A prognostic test that can predict the efficacy of hepatitis C treatments has been developed by scientists at Inserm and Institut Pasteur. The test, which is based on plasma levels of...

Boston Scientific Acquires Sadra Medical
06 January 2011 Boston Scientific Corporation has acquired US-based Sadra Medical. Under the terms of agreement, Boston Scientific has paid $193m to acquire the remaining 86% of Sadra Medical's...

US Researchers Develop Glaucoma Detector
06 January 2011 Researchers at the University of Arizona in the US have developed an instrument for detecting glaucoma, a disease caused by increased fluid pressure inside the eye. The device is designed...

ReSound Develops Technology to Improve Hearing Aid Performance
06 January 2011 A remote microphone technology that can improve the natural directivity, spatial awareness and wind-noise performance of hearing aids has been developed by ReSound. The technology uses a...

Gore Receives FDA Approval for Endoprosthesis Delivery Device
06 January 2011 WL Gore & Associates has received approval from the US Food and Drug Administration (FDA) for the GORE C3 delivery system. The system is used to deploy the Gore Excluder AAA...

Imaging Procedures Often Expose Children to Radiation
05 January 2011 Children are frequently exposed to imaging procedures that use radiation, according to a study conducted by researchers at University of Michigan in the US. Researchers identified...

Most Patients with ICDs Fail to Meet Criteria for Use
05 January 2011 Most patients who receive implantable cardioverter-defibrillators (ICDs) do not meet evidence-based guidelines to receive the devices, according to a study published in the Journal of the...

BD Diagnostics Submits First Automated HSV Tests to US FDA
05 January 2011 BD Diagnostics has filed for US Food and Drug Administration (FDA) 510(k) clearance for the first fully automated molecular tests to diagnose and differentiate HSV types 1 and 2. The...

Viewing Medical Images on Portable Media Unreliable, Says Study
05 January 2011 Radiologists and referring clinicians face problems while reviewing patient medical images from portable media such as CDs and DVDs, according to a study published in Journal of the...

Researchers Develop Test to Predict Lung Transplant Rejection
04 January 2011 Researchers at University of Michigan in the US have developed a test that can predict bronchiolitis obliterans syndrome (BOS), a leading cause of death in lung transplant recipients who...

US Researchers Develop Blood Test to Detect Cancer
04 January 2011 A test that can capture cancer cells from a blood sample has been developed by researchers at Massachusetts General Hospital, US. The test uses a microchip which consists of 78,000 tiny...

CPAP Reduces Sleep Apnoea Fatigue, Says Study
04 January 2011 Treatment with continuous positive airway pressure (CPAP) masks reduces the fatigue caused by obstructive sleep apnoea, according to a study conducted by researchers at the University...

PET Scans Could Evaluate Cognitive Dysfunction in Childhood Epilepsy
04 January 2011 PET scans can be used to evaluate cognitive dysfunction of fever-induced epilepsy in children, its evolution and further prognosis, according to a study published in the Journal of...

December 2010

Top

UK Hospital to Trial Retinal Implant
24 December 2010 King's College Hospital in the UK has reported that it will initiate clinical trials of a retinal implant for people with retinitis pigmentosa, one of the most common forms of inherited...

Season's Greetings
24 December 2010 medicaldevice-network.com will be taking a short break over the holiday season. Our full daily news service will return on 4 January. Thank you for your support in 2010, and we wish you a...

MRI and Cerebrospinal Fluid Testing May Predict Alzheimer's Risk
24 December 2010 A research team at University College London has discovered that combining spinal fluid testing with MRI scans could provide an early indication if an individual is at risk of...

FlexStent Biliary Self-Expanding Stent Receives FDA 510(k) Clearance
24 December 2010 Flexible Stenting Solutions has received 510(k) clearance from the US Food and Drug Administration (FDA) for an improved FlexStent biliary self-expanding stent delivery system and an expansion...

Abbott Recalls Blood Glucose Test Strips in US and Puerto Rico
24 December 2010 Abbott Diabetes Care has initiated a recall of 359 lots (approximately 359 million strips) of blood-glucose test strips in the US and Puerto Rico, as there is a risk that they may give an...

Biomet Completes Patient Enrolment for Tennis Elbow Treatment Study
23 December 2010 Biomet subsidiary Biomet Biologics has completed the required patient enrolment of 230 subjects for a clinical trial to evaluate the use of the Recover Kit for the treatment of chronic...

Medtronic Abdominal Aortic Aneurysm Stent Graft Receives FDA Approval
23 December 2010 Medtronic has received approval from the US Food and Drug Administration (FDA) for the Endurant stent graft system, used for the minimally invasive treatment of abdominal aortic aneurysms. ...

Researchers to Develop Electronic Nose to Detect Ovarian Cancer
23 December 2010 Researchers at the University of Gothenburg, University of Gävle and KTH Royal Institute of Technology are developing an electronic nose that can screen blood samples to detect ovarian...

Arrow Initiates Worldwide Recall of Series 5800 Intra-Aortic Balloon Catheters
23 December 2010 Arrow International has initiated a worldwide voluntary recall of 5800 Series intra-aortic balloon catheters with Super Arrow-Flex sheath introducers. The recall has been initiated by...

Tryton Trials Side Branch Stent System
22 December 2010 Tryton Medical has initiated patient enrolment in a pivotal trial to evaluate the Tryton side branch stent system for the treatment of coronary artery disease. The randomised and...

Advanced MRI Could be Used to Detect Prostate Cancer Progression
22 December 2010 An advanced type of MRI could be used instead of invasive biopsy to determine whether cancer patients under active surveillance require treatment, according to a study published in The...

Brain Imaging Could Predict Reading Improvement in Dyslexics
22 December 2010 Sophisticated brain imaging can be used to identify if teenagers with dyslexia can improve their reading skills over time with 90% accuracy, according to a study conducted by researchers at...

Aethlon Reports Hemopurifier Study Success
22 December 2010 Aethlon Medical has reported that its Hemopurifier demonstrated an ability to capture immunosuppressive exosomes derived from individuals with lymphoma and colorectal cancer in two studies. ...

Medtronic Receives Approval for Atrial Fibrillation Device
21 December 2010 Medtronic has received approval from the US Food and Drug Administration for their Arctic Front Cardiac CryoAblation Catheter system, which is indicated for the treatment of...

St Jude Medical to Take Defibrillator Cables off the Market
21 December 2010 St Jude Medical is taking a group of older defibrillator cables off the market as the insulating material used in them could cause a malfunction. The company has issued a letter to...

MHRA Warns of Risks Associated with Shiley Tracheostomy Tubes
21 December 2010 The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has recommended that healthcare staff exercise caution while using paediatric Shiley tracheostomy tubes, due to the risk...

Cystatin C Test Can Predict Kidney Disease Complications
21 December 2010 A blood test based on Cystatin C levels can effectively identify individuals with chronic kidney disease who have a high risk of complications, according to a study published in the Journal of...

MHRA Issues Warning over Surgical Instrument Problems
20 December 2010 The Medicines and Healthcare products Regulatory Agency (MHRA), UK, has issued a warning regarding possible problems associated with surgical instruments. According to the MHRA, it has received...

New Genetic Markers Could Improve Accuracy of Prostate Cancer
20 December 2010 Scientists from deCODE genetics have discovered genetic markers which improve the accuracy of prostate specific antigen (PSA) testing for detecting prostate cancer. The scientists discovered...

Gentag Develops Wireless Diagnostic Test
20 December 2010 Gentag and its partners have developed a new disposable wireless diagnostic test platform for mobile phones, which can test for fertility, pregnancy, pathogens, AIDS, drugs, allergens and...

Miracor Receives CE Mark for Coronary Revascularisation System
20 December 2010 Miracor Medical Systems has received the European Communauté Européenne (CE) Mark for the Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) impulse system. The system...

Accuray Receives FDA Clearance for Lung Cancer Treatment Component
17 December 2010 Accuray Incorporated has received 510(k) clearance from the US Food and Drug Administration (FDA) for Lung Optimised Treatment, a new component of the CyberKnife VSI System for the treatment...

SINTEF Scientists Develop Sensor Belt to Monitor Patients
17 December 2010 Scientists at SINTEF ICT have developed a sensor belt that monitors chronically ill patients and communicates the results via a mobile phone. The belt, which can be easily fitted, is...

European Commission to Develop Abdominal Aortic Aneurysm Devices
17 December 2010 The European Commission will develop less invasive, less expensive, and safer devices to treat conditions such as varicose veins and abdominal aortic aneurysms under the Heart-e-Gel...

Researchers Develop Carbon Nanotube to Probe Cells
17 December 2010 Researchers at Drexel University in the US have developed a carbon nanotube-based device that can probe single living cells without damaging them. The technique uses a cellular endoscope...

On-X Life Reports Positive Results for Prosthetic Heart Valve
16 December 2010 On-X Life Technologies has reported positive results from a large, prospective multi-centre Canadian trial of the On-X prosthetic heart valve. The study results revealed that the valve...

Insight Genetics, St Jude's to Develop Diagnostic Test for Cancer
16 December 2010 Insight Genetics has entered into an exclusive worldwide licensing agreement with St Jude Children's Research Hospital, to develop a diagnostic test that will enable physicians to monitor...

Endologix Acquires Nellix
16 December 2010 Endologix, a developer of minimally invasive treatments for aortic disorders, has completed the acquisition of Nellix. Nellix is the developer of a new device for the treatment of...

Swedish Scientists Use PET Scans to Track Alzheimer's
16 December 2010 Scientists at the Swedish medical university Karolinska Institutet have used a PET scanner to track the course of Alzheimer's disease in an individual patient from early development to...

Ultrasound Shows Promise in Endometrial Cancer Detection
15 December 2010 An ultrasound scan can be used to detect endometrial (womb) cancer before any symptoms occur, according to study conducted at University College London. The researchers analysed the...

Australian Scientists Develop Pain Management Implant
15 December 2010 Australian scientists are developing a tiny device that treats chronic pain by blocking the pain signals sent to the brain. The INS2 device, which consists of smart chips and a power...

UCSF to Test Hair Loss Treatment Devices in Cancer Patients
15 December 2010 Physicians at University of California, San Francisco (UCSF) have initiated a programme to test devices that can reduce scalp hair loss in breast cancer patients. As a part Hair to...

OraSure Initiates Patient Enrolment for HIV Test Study
15 December 2010 OraSure Technologies has initiated patient enrolment for the final phase of clinical studies for its OraQuick Rapid HIV-1/2 test for sale in the over-the-counter market. The US Food and...

Medtronic's Subclavian Aortic Valve System Approved
14 December 2010 Medtronic has received the European CE Mark approval for its Medtronic CoreValve System, which is implanted through the subclavian artery, located beneath the collar bone. The CoreValve...

UK Scientists to Develop Rapid STI Test
14 December 2010 Scientists at the University of Southampton in the UK are developing system that can detect sexually transmitted infections (STIs) within 15 minutes. The system will use short,...

Synergetics USA and Retinal Solutions to Develop Retinal Surgery Products
14 December 2010 Synergetics USA has entered into a product development and consulting agreement with Retinal Solutions to develop products for retinal surgery. The collaboration will combine...

FDA to Review Mercury Use in Dental Fillings
14 December 2010 The US Food and Drug Administration (FDA) is to review scientific evidence that claims that mercury in dental amalgam does not cause harm to patients. In July 2009, FDA had classified...

Researchers Develop Biosensor to Identify Dengue Virus
13 December 2010 Researchers at the A-STAR Institute of Microelectronics have developed a silicon nanowire-based biosensor that can detect dengue type 2 (DEN-2) viruses in less than 30 minutes. The device...

South African Government Halts Launch of Circumcision Device
13 December 2010 The South African government has halted the launch of a controversial male circumcision device known as Tara Klamps. Health department spokesman Fidel Hadebe said more research into the...

Chinese Scientists Develop Prenatal Genetic Disease Blood Test
13 December 2010 Scientists at the Chinese University of Hong Kong have developed a test that can identify the traits of genetic diseases in unborn children from a sample of the mother's blood. The...

Change in Inhaler Design Could Improve Drug Delivery
13 December 2010 Dry powder inhalers could be better designed and manufactured to suit an individual's unique physiological characteristics, such as age and height, according to research conducted by...

Scientists Identify Mechanism of Catheter-Related Bacterial Infection
10 December 2010 Scientists from the US National Institutes of Health have identified the mechanism through which catheter-related bacterial infections develop into a life-threatening condition. ...

NeuroWave Receives FDA Clearance for EEG Device
10 December 2010 NeuroWave Systems has received 510(k) clearance from the US Food and Drug Administration (FDA) its NeuroFAST Monitoring System, an electroencephalography (EEG) acquisition device. The...

Objet Geometries and Clearstep to Collaborate on Orthodontic Aligners
10 December 2010 Objet Geometries and Clearstep Laboratories have entered into a partnership to manufacture clear removable orthodontic aligners. The partnership is aimed at bringing the advantages of...

WHO Endorses Rapid Tuberculosis Test
10 December 2010 The World Health Organization (WHO) has endorsed a novel rapid test for tuberculosis. The fully automated nucleic acid amplification test incorporates modern DNA technology and can be...

FDA Advisory Committee Recommends Expanded Use of Gastric Banding System
09 December 2010 Allergan has reported that the US Food and Drug Administration Advisory Committee has recommended the expanded the use of the Lap-Band System for obese adults. The FDA Gastroenterology...

PET/CT Scans Could Predict Local Recurrence of Lung Cancer
09 December 2010 PET/CT scans can be used to predict local recurrence in lung cancer in patients treated with radiofrequency ablation, according to a study published in The Journal of Nuclear Medicine. ...

Abiomed Ends Cardiac Assist Device Study
09 December 2010 Abiomed has ended the study of Impella, its minimally invasive catheter-based cardiac assist device, based on a planned interim analysis of the primary endpoint. The study, designed to...

UCLA to Conduct Study of Heart Preservation Device
09 December 2010 The heart transplantation team at Ronald Reagan UCLA Medical Center in the US is conducting a Phase II clinical study of an experimental organ-preservation system, which allows donor hearts...

New Bio-Coating Could Improve Implant Performance
08 December 2010 Researchers at the University of Alabama (UAB) have developed a bio-coating technology that can improve the long-term performance of implantable medical devices such as heart valves and...

Conmed's Tissue Fusion Device Receives FDA Approval
08 December 2010 Conmed Corporation has received approval from the US Food and Drug Administration (FDA) for the Altrus Thermal Tissue Fusion System, a tissue fusion device indicated for use in a wide range...

Researchers Develop Implantable Artificial Kidney
08 December 2010 Researchers at the University of California, US, have developed the world's first implantable artificial kidney, which is capable of mimicking the kidney's most important functions such...

UK Researchers Develop Endoscope to Detect Inflammatory Bowel Disease
08 December 2010 A new kind of endoscope that could aid in the early diagnosis of inflammatory bowel disease has been developed by researchers at the University of East Anglia in the UK. The Confocal...

bioLytical Receives FDA Approval for HIV Test
07 December 2010 bioLytical Laboratories has received approval from the US Food and Drug Administration (FDA) for Insti, its rapid HIV antibody test. The FDA has approved Insti for the detection of...

AtriCure Initiates Atrial Fibrillation Trial
07 December 2010 AtriCure has initiated patient enrolment for a feasibility trial evaluating a dual epicardial / endocardial procedure for the treatment of patients with atrial fibrillation. The...

Rcadia Reports Positive Study Results of Coronary CT Analyser System
07 December 2010 Rcadia has reported positive study results of its COR Analyzer System, which is designed to perform fully automatic analyses of coronary CT angiography studies to identify the presence of...

St Jude Medical Reports Neurostimulation Device Study Success
07 December 2010 St Jude Medical has reported positive two-year follow-up results from a post-market clinical study evaluating neurostimulation for the management of chronic low back pain. The study...

CT Scans Show Significantly Low Cancer Risk
06 December 2010 The risk of developing radiation-induced cancer from CT is significantly low, according to a study conducted at Stanford University Medical Center in the US. The researchers conducted...

Researchers Develop Biologically Based Test for Autism
06 December 2010 Researchers at Harvard-affiliated McLean Hospital and the University of Utah, both in the US, have developed a new biologically based test for autism. The Lange-Lainhart test uses an...

Medical Device Registries Could Improve Patient Outcomes
06 December 2010 A standardised national registry of commonly used joint-replacement devices would improve patient outcomes, according to a research study conducted by health group Kaiser Permanente. The...

Researchers Develop Radiation-Free Breast Cancer Screening Device
06 December 2010 A portable, non-invasive and radiation-free device that can identify breast cancer has been developed by researchers at Drexel University in the US. The device works by measuring...

ConvaTec's Continence Device Demonstrates Safety and Efficacy
03 December 2010 ConvaTec has reported positive Phase II study results of Vitala, a non-invasive continence control device. The study showed that Vitala demonstrated safety and efficacy in providing up to...

US Researchers Develop Device to Treat Swallowing Problems
03 December 2010 Researchers at University of California Davis Health System in the US have developed a device that could provide effective treatment to those suffering from severe swallowing problems. ...

Magnetic Resonance Spectroscopy Could Help to Diagnose Brain Trauma
03 December 2010 Magnetic resonance spectroscopy can be used to diagnose chronic traumatic encephalopathy, a disorder caused by repetitive head trauma, a study conducted at Brigham and Women's Hospital in...

US Patients Prefer Home Medical Devices, Survey Finds
03 December 2010 The majority of US patients are interested in using home medical devices to manage and improve their chronic conditions, according to a survey conducted by GfK Roper for San Francisco-based...

Researchers Develop Plug-In Interface for Microfluidic Chips
02 December 2010 A new plug-in interface for microfluidic chips that can help with the development of compact medical devices has been developed by biomedical engineers at the University of California, US. ...

X-spine Spinal Implant Receives US Approval
02 December 2010 X-spine has received US approval for its Axle interspinous fusion system, a spinal implant that offers a less-invasive option for surgeons. The system is designed to provide spinal...

Blood Test Could Predict Cognitive Decline in Parkinson's Patients
02 December 2010 A blood test that can predict cognitive impairment in Parkinson's disease sufferers has been developed by researchers at the University of Pennsylvania School of Medicine in the US. The...

US Interventional Cardiology Market to Reach $5bn by 2017
02 December 2010 The US market for interventional cardiology is expected to reach nearly $5bn by 2017, according to a report by iData Research. The market will be driven by an increase in the sales...

UK Scientists Use Laser to Unblock Clogged Arteries
01 December 2010 A high-powered laser that can unblock arteries clogged with cholesterol in a matter of minutes has been developed by UK scientists. The device consists of a catheter called Turbo Elite,...

Micell Initiates Patient Enrolment for Coronary Stent Study
01 December 2010 Micell Technologies has initiated patient enrolment for a clinical trial of MiStent DES, its investigational drug-eluting stent for the treatment of coronary artery disease. The...

Toshiba Announces Trials for Non-Contrast Renal MR Angiography System
01 December 2010 Toshiba has announced a multi-centre clinical trial to evaluate its non-contrast Time-SLIP renal MR angiography as a method of diagnosing renal artery stenosis. The study will compare...

BD Nexiva Catheter Provides Improved Stabilisation, Says Study
01 December 2010 BD's Nexiva closed IV catheter system with 3M tegaderm IV securement dressing provides effective catheter stabilisation at a lower component cost than a traditional IV catheter with an...

November 2010

Top

Autonomy Corporation Diagnosis Tool Wins Technology Award
30 November 2010 Autonomy Corporation's Autonomy Auminence, a point-of-care analysis dashboard, has won the 2010 Healthcare IT Summit innovation award for Best New Technology. Autonomy Auminence enables...

Global Dental Implants Market to Reach $4.2bn in 2015
30 November 2010 Dental implants are estimated to have one of the highest growth rates amongst all dental device submarkets, according to a report by Sandler Research. The global dental implants market,...

Study Recommended MRI Screening for Women with Personal History of Breast Cancer
30 November 2010 Women with personal history of breast cancer should be given annual MRI screenings in addition to mammography, according to a study conducted at the University of Washington Medical Center in...

Rapid Microscopy Technique Can Identify Cancer Cells
30 November 2010 A novel microscopy technique that can rapidly and accurately find cancer cells has been developed by researchers at the University of Illinois in the US. The technique,...

Catheter Ablation Can Reduce Atrial Fibrillation Symptoms
29 November 2010 Atrial fibrillation patients treated with Biosense Webster's NaviStar ThermoCool catheter have reduced symptoms and improved the quality of life compared to patients treated with...

Roche's HPV Test Effective at Identifying Pre-Cancerous Cervical Cells
29 November 2010 A study involving more than 47,000 women has proven that Roche's cobas 4800 Human Papillomavirus (HPV) test is effective in identifying pre-cancerous cells in patients who had normal Pap smears. ...

Advanced Bionics to Recall Cochlear Implant
29 November 2010 Advanced Bionics has notified the US Food and Drug Administration (FDA) that it will voluntarily initiate a worldwide recall of its HiRes 90K cochlear implant due to a malfunction risk. ...

True Whole-Body Field View PET/CT Better at Staging Cancer
29 November 2010 Using true whole-body field view during PET/CT scanning can result in more accurate cancer staging than using a limited whole-body field of view, a study published in the American Journal...

Ultrasound Could Help to Evaluate Focal Breast Abnormalities
26 November 2010 Targeted breast ultrasound should be the primary imaging technique to evaluate focal breast signs and symptoms in women younger than 30, according to a study published in the American Journal...

Titanium-Based Dental Implant Could Cut Treatment Costs
26 November 2010 Indian scientists have developed a titanium-based implant that can cut the costs associated with dental treatment by more than 60%. Apart from providing a replacement for lost teeth, the...

Urine Protein Test Can Predict Pre-Eclampsia
26 November 2010 Researchers at the UK's University of Leicester have developed a urine test that can predict if pregnant women are likely to develop pre-eclampsia, a serious pregnancy complication. ...

Implanted Heart Devices Pass Real-World Test
26 November 2010 Implantable devices to treat cardiac dysfunction in heart failure patients are as effective in the real world as in clinical trial settings, a study published in the Journal of the American...

Medtronic to Acquire Ardian for $800m
25 November 2010 Medtronic has signed a definitive agreement to acquire catheter-specialist Ardian for $800m. In addition, Medtronic will pay commercial milestones equal to the annual revenue growth through...

Spinal Implant Allows Paraplegics to Exercise
25 November 2010 A spinal implant to help paraplegic patients exercise their paralysed leg muscles has been created. The device, a microchip the size of a child's fingernail, is works by stimulating the...

Researchers Develop Device to Strengthen Swallowing Muscles in Parkinson's Patients
25 November 2010 Researchers at the University of Florida have developed a device to help people with Parkinson's disease keep the ability to swallow. The device strengthens the muscles, which...

Three Boston Scientific Defibrillators Receive CE Mark
25 November 2010 Boston Scientific has received CE Mark approval for three of its cardiac resynchronisation therapy defibrillators and implantable cardioverter defibrillators. The PUNCTUA, ENERGEN and...

Taiwanese Blood-Glucose Devices Market to Reach $86m by 2016
24 November 2010 The self-monitoring blood-glucose devices and strips market in Taiwan is estimated to be worth $86m by 2016, according to an analysis from Frost & Sullivan. The reports says that...

Study Recommends Shockwaves to Treat Small Kidney Stones
24 November 2010 A study by surgeons at University Federico II in Italy has recommended that extracorporeal shockwave lithotripsy (ESWL) is used to remove smaller kidney stones trapped in the distal ureter. ...

Medtronic Reports Positive Results of Cardiac Monitor Study
24 November 2010 Medtronic has reported positive results of a study to evaluate the ability of its Reveal insertable cardiac monitor to diagnose patients with recurrent syncopal (fainting) events. The...

Carestream Health Receives FDA Approval for Mammography System
24 November 2010 Carestream Health has received approval from the US Food and Drug Administration (FDA) for its CR Mammography System, a computed radiography system for breast imaging. The system's...

Covidien Reports Positive Catheter Study Results
23 November 2010 Covidien has reported positive results from of a study of its ClosureFAST catheter, which is used for the treatment of varicose veins. The study results found that ClosureFAST...

Retailer Fined for Selling Non-Compliant Medical Devices in UK
23 November 2010 Poundworld Retail has been fined £5,000 and ordered to pay costs of £9,000 for selling defective and non-compliant medical devices in the UK. An investigation by the Medicines and...

Researchers Develop Mobile-Phone Based Blood Pressure Monitor
23 November 2010 Researchers at the University of Toronto, Canada, have developed a mobile-phone based system to monitor blood pressure. The monitoring system automatically picks up the patient's home...

Ardian Hypertension Catheter Succeeds in Trial
23 November 2010 Ardian has reported that its catheter system for the treatment of hypertension has met the primary endpoint of a clinical study. The international, multi-centre, prospective, randomised...

US Researchers Develop Genetic Test for Deafness
22 November 2010 A test to determine the genetic cause of inherited deafness has been developed by researchers at the University of Iowa, US. The OtoSCOPE test uses the latest DNA sequencing technology...

U-Systems Initiates Study of Breast Ultrasound System
22 November 2010 U-Systems has initiated patient enrolment for a study to evaluate the somov automated breast ultrasound, its 3D ultrasound imaging system, in women with dense breast tissue. The clinical...

Canon Receives FDA Clearance for Retinal Camera
22 November 2010 Canon has received US Food and Drug Administration (FDA) approval for its CR-2 digital non-mydriatic retinal camera. The camera weighs about 33 pounds and has an illuminated control...

Researchers Develop Neurostimulation System to Treat Stroke
22 November 2010 Researchers at Israel-based Brainsgate have developed a system that uses electrical stimulation to treat ischemic stroke. The system consists of miniature neurostimulator, a...

St Jude and Zonare to Develop and Market Ultrasound System
19 November 2010 St Jude Medical and Zonare Medical Systems have entered into a partnership to develop and market a co-branded ultrasound console. St Jude will combine its intracardiac echocardiography...

Pyng Initiates Voluntary Recall of Sternal Intraosseous Device
19 November 2010 Pyng Medical has initiated a voluntary recall of its FASTx sternal intraosseous device following concerns over its performance. The company said it had received feedback about the...

US Handheld Ultrasound Market Forecast to Exceed $1.2bn by 2016
19 November 2010 The US handheld ultrasound imaging market is forecast to surpass $1.2bn by 2016, according to a report by iData Research. Market growth is expected to be driven by the increased adoption of...

Edwards Transcatheter Valve Improves Quality of Life, Study Finds
19 November 2010 Edwards Lifesciences Corporation has reported that its Sapien transcatheter heart valve substantially improved the quality of life in patients with inoperable aortic stenosis in a clinical trial. ...

US Researchers Identify Protein That Could Predict Heart Failure
18 November 2010 A blood test could identify heart failure risk among older people has been developed by researchers at the University of Maryland, US. The test works by detecting levels of troponin T (cTnT),...

FDA Launches External Defibrillator Improvement Programme
18 November 2010 The US Food and Drug Administration (FDA) has launched a programme to facilitate the development of safer and more effective external defibrillators through improved design and...

Implantable Devices Can Identify Stroke Risk, Says Study
18 November 2010 St Jude Medical has announced the results of a study that demonstrates the effectiveness of implantable device monitoring as a way to predict the risk of stroke in elderly patients. The...

NMT Septal Repair Implant Fails Study Goal
18 November 2010 NMT Medical has reported that Starflex, its septal repair implant to prevent stroke, has not met the endpoint of a trial. The results indicated that Starflex plus medical therapy did...

WHO Endorses Rapid Tuberculosis Test
17 November 2010 A rapid and low-cost test that can diagnose tuberculosis and determine its drug resistance has been endorsed by the World Health Organization (WHO) for use in areas which have few...

Brain Scan Could Predict Paediatric Anxiety Disorder Treatment Outcomes
17 November 2010 A functional MRI (fMRI) brain scan could be used to predict if children with paediatric anxiety disorder will respond to cognitive behavioural therapy. Neuroscientists at Georgetown...

Si-Bone Receives CE Mark for Sacroiliac Joint Treatment System
17 November 2010 Si-Bone has received CE Mark approval for its iFuse Implant System, a minimally invasive device used to treat the sacroiliac joint. The system is indicated for fracture fixation of large...

PWB Health Recalls Breast Cancer Detection Device
17 November 2010 A home screening device to help women detect breast cancer early is being recalled in Canada, after an evaluation of the device found no clinical evidence that it works. PWB Health issued...

Medtronic Reports Positive Cardiac Resynchronisation Device Trial
16 November 2010 Medtronic has reported positive results from a clinical trial designed to evaluate the use of its cardiac resynchronisation therapy-defibrillators (CRT-Ds) on mildly symptomatic heart...

EU Funds Neurodegenerative Diagnostic Device Programme
16 November 2010 The EU has granted €9m for the development of a lab-on-chip to detect neurodegenerative diseases such as Alzheimer's and Parkinson's. A consortium of 18 partners will take up...

Urine Test Could Diagnose Kidney Injury
16 November 2010 A urine test that could be used to diagnose acute kidney injury has been developed by researchers at Fred Hutchinson Cancer Research Center in the US. The test is based on...

HeartWare Reports Positive Study Results of Heart Pump
16 November 2010 HeartWare International has reported positive study results for the HeartWare ventricular assist system, an implantable pump designed to extend the life of heart-failure patients. The...

Researchers Use Tracking System to Identify Faulty Medical Devices
15 November 2010 Computerised tracking systems can be used to identify faulty medical devices, according to a study published in the Journal of the American Medical Association. US researchers used a...

Arstasis Initiates Patient Enrolment for Femoral Artery Closure System Trial
15 November 2010 Arstasis has initiated patient enrolment in a study to evaluate the Arstasis One Access system, which is designed to increase the security of a femoral artery closure in patients...

Scientists Use Microwaves to Monitor Vital Signs
15 November 2010 Scientists in Japan have developed a technique that uses microwaves to measure a patient's vital signs. The system uses weak microwaves to irradiate and scatter off the human body. A...

Mederi Receives CE Mark for Gastric Reflux and Incontinence Devices
15 November 2010 Mederi Therapeutics has received CE Mark approval for two devices, one to treat gastric reflux disease and the other to treat bowel control disorder. The second-generation Stretta system...

UK Researchers Working on Confidential STD Test
12 November 2010 Researchers at the UK Clinical Research Collaboration are developing a computer chip that can rapidly detect sexually transmitted diseases (STDs). The device analyses urine or saliva samples...

Solar-Powered Device to Measure Blood Pressure Unveiled
12 November 2010 A solar-powered device to measure blood pressure can provide affordable and reliable testing in low-income countries, according to a research published in Hypertension: Journal of the...

Researchers Develop Heart Pump for Congenital Heart Disease Surgery in Infants
12 November 2010 A heart pump for infants that be used during surgery has been developed by researchers at Purdue University in the US. The viscous impeller pump is designed for treating infants...

EnteroMedics Reports Results of Obesity Device Studies
12 November 2010 EnteroMedics has reported the clinical results from two studies to evaluate VBLOC, its vagal blocking therapy for the treatment of obesity. VBLOC therapy is devliver by the implanted...

Ultrasound Needle Guidance Found to Improve Knee Injection Outcomes
11 November 2010 The use of ultrasound needle guidance for intra-articular injections can improve the overall treatment of knee osteoarthritis, according to research presented at the American College...

FDA Proposes Changes to Prevent Radiation Overdoses
11 November 2010 The US Food and Drug Administration (FDA) is proposing changes to protect patients from radiation overdoses during CT scans. The move comes after the FDA carried out an investigation into...

Multidetector CT Could be Used to Identify Stroke Causes
11 November 2010 Multidetector CT can be used to identify the causes of ischaemic strokes, according to a study published in Radiology. Researchers compared a single-session multidetector CT examination...

Boston Scientific Initiates Patient Enrolment for Parkinson's Disease System Trial
11 November 2010 Boston Scientific Corporation has initiated patient enrolment for the clinical trial of its Vercise deep brain stimulation system, which is used for the treatment of Parkinson's disease. ...

Combined Imaging Technologies Could Improve Breast Cancer Detection
10 November 2010 A combination of optical and X-ray imaging can be used to distinguish malignant breast cancers from benign lesions, according to a study conducted at Massachusetts General Hospital in the...

Researchers Develop Life Expectancy Test for Terminal Cancer Patients
10 November 2010 Researchers in the UK have created a computer model to calculate the life expectancy of terminally ill cancer patients. The model, developed at Manchester University and St George's Hospital...

WalkMed Initiates Infusion Pump Recall
10 November 2010 WalkMed Infusion has initiated a recall of more than 2,000 of its Triton pole-mount infusion pumps in the US, after it found a defect that could cause the over infusion of medication. ...

Cardio Surgery Devices Market to Reach $2.4bn in 2016
10 November 2010 The global market for cardiovascular surgery devices is estimated to reach $2.4bn in 2016, according to a report by GlobalData. The market was valued at $2bn in 2009. Growth is expected to...

Low-Dose CTs Prevent More Lung Cancer Deaths than X-Rays
09 November 2010 Low-dose CT is more effective at preventing deaths from lung cancer than a chest X-ray, according to a new study conducted by the National Cancer Institute (NCI). The NCI's National...

Covidien Receives Clearance for Venous Thromboembolism System
09 November 2010 Covidien has received 510(k) clearance from the US Food and Drug Administration for the Kendall SCD Sequential Compression Comfort Sleeve and the Kendall SCD 700 Series Controller, which is used...

FDA Reclassifies Digital Mammography Systems as Class II Devices
09 November 2010 The US Food and Drug Administration (FDA) has reclassified full field digital mammography systems from Class III to Class II devices. The FDA classifies medical devices into three...

CARE Fertility Test May Improve IVF Success Rates
09 November 2010 Researchers at UK-based CARE Fertility have developed a test that can increase the chances of having a baby through in-vitro fertilisation (IVF). Chromosomal abnormalities are a major cause...

MiCardia Receives CE Mark for Mitral Regurgitation Device
08 November 2010 MiCardia Corporation has received the CE Mark approval for its enCor Mitral valve repair system, which is indicated for the treatment of mitral regurgitation. The enCor device allows...

Researchers Develop Blood Test for Niemann-Pick Type C Disease
08 November 2010 Researchers at Washington University School of Medicine in St Louis and the National Institutes of Health (NIH), US, have developed a simple blood test for diagnosis of Niemann-Pick type C...

UK Scientists Develop Jellyfish Protein Cancer Test
08 November 2010 Scientists at The University of York, UK, have developed a new test that uses cells derived from jellyfish to detect cancers deep within the human body. The scientists isolated...

Atrium Completes Patient Enrolment for iCAST Stent Trial
08 November 2010 Atrium Medical Corporation has completed patient enrolment for a study of the Atrium iCAST Balloon Expandable Covered Stent for the treatment of patients with iliac artery occlusive...

JenaValve Launches Aortic Stenosis System Study
05 November 2010 JenaValve Technology has initiated a multi-centre CE-mark study of its transapical TAVI system, which is designed for the treatment of severe stenotic aortic valve disease. The...

Elderly Women at High Risk of Inappropriate Urinary Catheterisations
05 November 2010 Elderly women face a high risk of inappropriate urinary catheterisations in emergency departments, according to a new study published in the American Journal of Infection Control. During...

Researchers Develop Gender Prediction Test
05 November 2010 Researchers at Sheba Medical Centre, Israel, have developed a new DNA test that can identify the sex of an unborn child at only seven weeks. The test involves taking a blood sample from...

Researchers Develop Eye Implant to Restore Vision
05 November 2010 Scientists at Retinal Implant have developed an eye implant that enables patients with the degenerative eye disease retinitis pigmentosa to see shapes and objects. The device, known as...

MRI Could Predict Ischemic Stroke Onset
04 November 2010 Magnetic resonance imaging (MRI) can be used to determine the time of ischemic stroke onset, which would allow doctors to provide life-saving treatment, according to a new study published in...

Clinical Trial Combines Genetic Test with CT Scan to Diagnose Lung Cancer
04 November 2010 Physicians at El Camino Hospital, California, US, have initiated a clinical trial to evaluate a new tool for the early diagnosis of lung cancer. The trial will combine Respiragene, a...

DNA Electronics and 454 Life Sciences to Develop DNA Sequencing System
04 November 2010 DNA Electronics and 454 Life Sciences, a Roche Company, have entered into a partnership to develop a high-throughput, low-cost, long-read, high-density DNA sequencing system. Under...

Medtronic Receives FDA Approval for Thoracic Stent Graft
04 November 2010 Medtronic has received US Food and Drug Administration (FDA) approval for Talent thoracic stent graft with Captivia delivery system, which is indicated for the endovascular repair of...

FDA Categorises Medtronic Tissue Stabiliser Recall as Class I
03 November 2010 Medtronic has reported that the US Food and Drug Administration (FDA) has classified the company's recall of Octopus Nuvo Tissue Stabiliser as Class I. A recall is classified as Class I...

US Researchers Unveil Blood Test for Ectopic Pregnancies
03 November 2010 Researchers at University of Pennsylvania School of Medicine in the US have developed a blood test to diagnose ectopic pregnancy, a complication where the foetus implants itself outside the womb. ...

United Arab Emirates Bans the Sale of Two Medical Devices
03 November 2010 The Ministry of Health in the United Arab Emirates has banned the sale and use of two medical devices, one used in dialysis and the other as a lung sealant. Officials issued a...

Penumbra Initiates Patient Enrolment for Stroke Stent Study
03 November 2010 Penumbra has initiated patient enrolment for a clinical trial of its Pulse flow restoration device, a temporary stent for the treatment of acute ischaemic stroke. The clinical trial...

ArthroCare Receives US Approval for Suture Implant System
02 November 2010 ArthroCare has received US Food and Drug Administration approval for its Spartan polyether-etherketone (PEEK) suture implant system, which is indicated for use in fixation of soft tissue to bone. ...

Researchers Initiate Trial of Vertebral Compression Fracture Device
02 November 2010 US researchers have begun a clinical trial to evaluate the safety and effectiveness of the Kiva System, which is used for the treatment of painful vertebral compression fractures caused...

EU Commission Warns of Device Reprocessing Dangers
02 November 2010 The European Commission has revealed that there are three major risks associated with the reprocessing of single-use medical devices. In a report, the commission warned of the dangers...

Researchers Develop Endoscopic Drug Delivery Device for Colorectal Cancer
02 November 2010 Researchers at University College Cork in Ireland have developed an endoscopic device that can deliver chemotherapy drugs to colorectal tumours in a localised way. The EndoVe device...

Exact Sciences Reports Positive Study Results for Colorectal Cancer Test
01 November 2010 Exact Sciences has reported positive study results for Cologuard (sDNA), a non-invasive stool-based screening test for colorectal cancer. The study results showed that the test detected 64%...

Researchers to Develop Blood Test for Cancer
01 November 2010 Researchers at the Technion-Israel Institute of Technology are developing a blood test to diagnose cancer using biomarkers. The test is based on the human leukocyte antigen (HLA) system...

Researchers Develop Imaging Technique for Breast Cancer
01 November 2010 Cancer Research UK scientists have developed an imaging technique that can show whether breast cancer treatment is working weeks before current methods. The scientists developed two...

Calypso Medical Initiates Trial of Lung Tumour Tracking System
01 November 2010 Calypso Medical Technologies has initiated a clinical trial to evaluate the Calypso System for tracking lung cancer tumours during radiation delivery. The trial will also assess the new...

October 2010

Top

Patient Enrolment for Cancer Pain Therapy Study Begins
29 October 2010 Competitive Technologies has initiated patient enrolment for a Phase II clinical study of its Calmare pain therapy medical device, which is indicated for the treatment of cancer pain syndromes. ...

US Medical Adhesives and Sealants Market to Reach $1.84bn by 2015
29 October 2010 The US medical adhesives and sealants market is estimated to reach $1.84bn by 2015, according to a report by Global Industry Analysts. Although the economic recession adversely affected...

Portable Scanner Developed to Detect Breast Cancer
29 October 2010 Scientists at the University of Manchester in the UK have developed a portable scanner that uses radio frequency technology to detect breast cancer. The scanner analyses dielectric...

Passive Safety Devices Prevent Needlestick Injuries, Study Suggests
29 October 2010 Passive and fully automatic safety devices offer more protection from accidental needlestick injuries than active devices, according to a study conducted by the Groupe d'Etude sur le...

US Intermittent Catheter Market to Double by 2014
28 October 2010 The US intermittent catheter market in the US is expected to double in value by 2014, according to a report by the Millennium Research Group. The market is valued at $230m, and demand...

CorMatrix Reports Positive Study Results for Pericardial Closure Implant
28 October 2010 CorMatrix Cardiovascular has reported positive study results of its extracellular matrix (ECM) technology, an implant used to reconstruct the pericardium. The study was conducted by...

Boston Scientific Acquires Asthmatx
28 October 2010 Boston Scientific Corporation has completed its acquisition of Asthmatx, purchasing all outstanding shares for $193.5m. There is potential for a further $250m in additional payments,...

EDAP Completes First Stage of Ultrasound Trial
28 October 2010 EDAP TMS said that it has successfully completed the first phase of clinical study evaluating high-intensity focused ultrasound (HIFU) technology in patients with metastatic liver cancer. ...

FDA Approves Roche Hepatitis C Test
27 October 2010 Roche has received US Food and Drug Administration (FDA) approval for its PCR COBAS TaqMan HCV test, v2.0, a second-generation hepatitis C viral load test. The test is designed to quantify...

Emotional Health Monitoring Smart Phone App Released
27 October 2010 The US Department of Defense has released a free smart phone application to help military personnel and veterans track their emotional health after deployments. The T2 Mood Tracker...

Israeli Researchers Develop Device to Diagnose Sleep Apnoea
27 October 2010 Israeli researchers have developed a device that can diagnose obstructive sleep apnoea at home. The WatchPAT device, developed and manufactured by Itamar Medical in Caesarea, Israel, is worn...

Tengion Reports First Neo-Urinary Conduit Implantation
27 October 2010 Tengion has implanted its first neo-urinary conduit in a patient, as part of an ongoing clinical trial of the device in bladder cancer patients who have undergone bladder removal. The...

Biliary Stricture Stent Receives CE Mark
26 October 2010 Boston Scientific has received CE mark approval for its WallFlex biliary RX fully covered stent for the treatment of benign biliary strictures. The WallFlex biliary RX is made of...

Researchers Develop Synthetic Bone Material
26 October 2010 Researchers at UMass Medical School, US, have developed an inexpensive, synthetic bone material that can be used to repair complex fractures and large areas of bone loss. Researchers...

Microchip Could Separate Tumour Cells from Blood Samples
26 October 2010 Researchers at the Spanish National Research Council have developed a microchip that uses ultrasound waves to separate and extract tumour cells from a blood sample. The patented...

Researchers Develop Blood Test for Chronic Kidney Disease
26 October 2010 Measuring three blood biomarkers could help to identify patients that have a high risk of developing chronic kidney disease, according to a study published in the Journal of the American Society...

US Patient Monitoring Market to Reach $4bn by 2017
25 October 2010 The US patient monitoring market is estimated to reach $4bn by 2017, according to a report by iData Research. Multi-parameter vital-sign devices represented the majority of the market in...

TransEnterix Receives CE Mark for Surgical System
25 October 2010 TransEnterix has received CE mark approval for its Spider surgical system, a device that enables a surgeon to operate through a patient's belly button. The system allows surgeons to operate...

US Researchers Develop Device to Treat Vertigo
25 October 2010 Researchers at University of Washington Medical Center, US, have developed a device to treat vertigo associated with Meniere's disease. Meniere's disease is disorder that affects hearing...

Aethlon Initiates Patient Enrolment for Hemopurifier Study
25 October 2010 Aethlon Medical has initiated enrolment for a study to evaluate the use of its Hemopurifier for the treatment of patients with the hepatitis C virus (HCV). The Aethlon Hemopurifier...

US Researchers Awarded Grant for Brain Monitoring Device
22 October 2010 Researchers at the University of Cincinnati, US, have received a $2.1m grant from the US Department of Defense to help them develop the next generation of brain monitors. They are working on...

Opto Circuits to Acquire Cardiac Science
22 October 2010 Cardiac Science Corporation and Opto Circuits have entered into a definitive merger agreement, under which Opto Circuits will buy all the outstanding shares of Cardiac Science common stock...

Study Deems Pacemakers Reuse Safe and Effective
22 October 2010 The reuse of pacemakers is safe, effective and poses little risk of infection, according to a study conducted at the University of Michigan Cardiovascular Center, US. The research added...

Spectral Diagnostics Begins Haemoperfusion Device Trial
22 October 2010 Spectral Diagnostics has initiated a US trial of Toraymyxin, a therapeutic haemoperfusion device for the treatment of patients with severe sepsis. Toraymyxin works by removing endotoxins,...

Masimo Reports Positive Haemoglobin Monitor Study Results
21 October 2010 Masimo has reported that a randomised controlled trial of SpHb, its non-invasive and continuous haemoglobin monitor, has shown that the device helped anaesthesiologists reduce the frequency...

Devon Medical Receives US Approval for Lymphoedema Pumps
21 October 2010 Devon Medical Products has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CircuFlow 5100 and 5200 sequential pumps for the treatment of venous insufficiency...

Early Menopause Gene Discovery Could Lead to Predictive Test
21 October 2010 Scientists in the UK have identified genes related to the early onset of the menopause, opening the way for a predictive genetic test. In a study, researchers from the University of...

US Medical Device Market to Reach $94.9bn in 2010
21 October 2010 The value of the US medical device market is estimated to reach $94.9bn in 2010, according to a report by Espicom Healthcare Intelligence. Medical device imports now comprise 30% of the...

NinePoint Medical to Develop Cancer Diagnosis Devices
20 October 2010 NinePoint Medical has announced that it is developing an in vivo pathology technology platform to develop and commercialise a portfolio of medical devices for the examination of...

Researchers to Trial Eye Device for Cancer Drug Delivery
20 October 2010 The Vision Center at Childrens Hospital Los Angeles in the US has been offered a $1m grant from the National Cancer Institute to conduct clinical trials on a cancer drug delivery device to...

CareFusion Infusion Pump Recall Classified as Class I
20 October 2010 CareFusion has reported that its recall of approximately 17,000 Alaris PC (model 8015) infusion pump units has been classified as Class I by the US Food and Drug Administration (FDA). A Class...

St Jude Medical Acquires AGA Medical
20 October 2010 St Jude Medical has entered into a definitive agreement to acquire all outstanding shares of AGA Medical Holdings, the market leader in structural heart defect occluders, for approximately $1.3bn....

Knee Device Should Not Have Been Approved, Says FDA
19 October 2010 The US Food and Drug Administration (FDA) has admitted that it should not have approved the Menaflex collagen scaffold, an orthopaedic device used in the knee. The watchdog approved the...

PneumRx Receives CE Mark for Emphysema Device
19 October 2010 PneumRx has received CE mark approval for its RePneu lung volume reduction coil (LVRC) system, a minimally invasive device for the treatment of the later stages of emphysema. The system...

UK Scientists to Develop Urine Test for Prostate Cancer
19 October 2010 Scientists from two cancer research organisations in the UK are developing a urine test that could identify men at risk of prostate cancer. The test is based on a protein...

US Scientists to Conduct First Robot-Assisted Prostate Cancer Trial
19 October 2010 A first-of-its-kind clinical trial is to use a robot to perform prostate brachytherapy, a procedure that involves the placement of 60-120 therapeutic radioactive seeds in the tumours of...

Positive Results for Vital Therapies Bioartificial Liver System
18 October 2010 Vital Therapies has reported positive three-year follow-up study results of ELAD, its bioartificial system for the treatment of patients with acute liver failure. The randomised, controlled...

MRI Shows Promise in Diagnosing Brain Disorders
18 October 2010 Researchers at the University of Illinois at Chicago, US, have successfully used brain imaging to differentiate between attention deficit hyperactivity disorder (ADHD) and paediatric...

Biomerix Granted US Patent for Tissue Scaffold
18 October 2010 Biomerix Corporation has been awarded a US Patent for its proprietary biomaterial platform technology. Biomerix Biomaterial is a non-resorbable reticulated polycarbonate...

New Tool Could Optimise Cardiovascular Device Design
18 October 2010 Researchers at Stony Brook University, US, have developed a device that can be used to optimise cardiovascular device design to eliminate the risk of clot formation. The device...

Singapore Researchers Develop Device to Predict Heart Failure
15 October 2010 Researchers at Singapore General Hospital and Nanyang Technological University have developed a device that can predict a patient's risk of heart failure. The non-invasive device...

Genomic Health Reports Positive Breast Cancer Test Trial
15 October 2010 Genomic Health has reported positive study results from a trial of its Oncotype DX breast cancer test, which it found had a significant effect on the treatment decisions made by doctors. ...

Tinnitus Device Performs Well in Trial
15 October 2010 Tinnitus Laboratory has reported positive study results of Paxx100, its customised audio device for the management of tinnitus. The study involved 41 participants, who were asked to use...

Myriad Prostate Cancer Test Accurately Predicts Survival
15 October 2010 A study has shown that Prolaris, a molecular diagnostic test developed by Myriad Genetics, accurately predicts survival rates for prostate cancer patients. The study evaluated the ability...

Stanford and Varian Scientists Partner to Develop New Imaging Technology
14 October 2010 Scientists from Stanford University and Varian Medical Systems are working on a new imaging technology to improve the quality of CT images from patients with metal objects in their bodies such...

Drug Release Implants Show Potential in Treating Addicts
14 October 2010 An implantable device that releases small doses of medication can help to wean drug addicts off heroin or prescription painkillers, according to a study conducted at the University of...

US Researchers Improve CTC Chip
14 October 2010 Researchers from Massachusetts General Hospital, US, have successfully redesigned the CTC chip to make it more effective at capturing circulating tumour cells (CTCs). The new HB chip uses...

Study Suggests MRI Could Help Diagnose Autism
14 October 2010 A study conducted at the University of Utah, US, has suggested that MRI could be used to help diagnose autism. Researchers enrolled 90 people, 53 of whom had autism, and used MRI to compare...

Menssana to Develop Breath Test for Radiation Exposure
13 October 2010 Scientists at Menssana Research are developing a test that can detect whether individuals have been exposed to radiation by analysing their breath. The test will allow emergency transponders...

Carotid Artery Stenting Linked to Increased Stroke Risk
13 October 2010 Carotid artery stenting causes a greater risk of adverse outcomes compared with surgical treatment by carotid endarterectomy, according to a study from the New York University School of...

Chinese Cardiovascular Market to Reach $1.6bn by 2016
13 October 2010 The cardiovascular market in China is estimated to reach $1.6bn by 2016, according to a report by GlobalData. Large numbers of people in China are at risk of cardiovascular diseases due to...

OrbusNeich Completes Patient Enrolment for Stent Trial
13 October 2010 OrbusNeich has completed the enrolment of 180 patients for a randomised clinical trial of its Genous bio-engineered R stent. The clinical trial, which is being conducted at 11 sites in...

Researchers Find Biomarkers to Test for River Blindness
12 October 2010 Researchers from the Scripps Research Institute have developed a test to diagnose river blindness, a parasitic disease caused by the Onchocerca volvulus worm. The team used metabolomics...

FDA Awards ALS Device Humanitarian Use Status
12 October 2010 The US Food and Drug Administration (FDA) has granted humanitarian use device designation to Synapse Biomedical for its NeuRx diaphragm pacing system, which is used for the treatment of...

Ultrasound Device Could Speed Up Fracture Healing
12 October 2010 Low-intensity pulsed ultrasound (LIPUS) can speed up the healing of fractures, a German study has discovered. Researchers from the University Hospital Marburg and the University of Ulm...

Researchers Develop Potential Pre-Screening Test for Lung Cancer
12 October 2010 US researchers have developed an optical technique that can be used to detect the early signs of lung cancer. Partial wave spectroscopic microscopy works on the principle of field effect –...

MRI and CT Scan Use Triples in US
11 October 2010 The use of MRI and CT scans in US emergency departments tripled between 1998 and 2007, according to a study carried out at Johns Hopkins University. Researchers found that patients...

Artificial Pancreatic Tissue Offers Hope for Diabetics
11 October 2010 Surgeons at Massachusetts General Hospital, US, have developed a bio-artificial matrix that could serve as a scaffold for pancreatic islets and supportive stem cells. The researchers found...

Gene Test Could Reduce Unnecessary Angiograms
11 October 2010 A gene test developed by US researchers could reduce the number of unnecessary angiograms among suspected heart disease patients. The test, developed by Scripps Health, analyses the activity...

Kinetic Hernia Repair Mesh Successful in Trial
11 October 2010 Kinetic Concepts has announced favourable study results of its LifeCell Strattice Reconstructive Tissue Matrix, a device used for the single-stage repair of infected or contaminated...

MRI Used to Predict Progressive Mild Cognitive Impairment
08 October 2010 A combination of MRI and artificial intelligence techniques can be used to identify deterioration in patients with mild cognitive impairment (MCI), according to a study conducted at...

Webcam Used for Vital Signs Monitoring
08 October 2010 Researchers from Massachusetts Institute of Technology have developed a system that can measure a patient's vital signs using a low-resolution webcam. The system works by measuring...

Researchers Develop Blood Test for Alzheimer's
08 October 2010 A set of proteins found in the blood serum can help to accurately diagnose Alzheimer’s disease, according to a study conducted by researchers at the University of Texas Southwestern Medical...

FDA Awards Information Hub Development Contract
08 October 2010 The US Food and Drug Administration (FDA) has awarded the Pan American Health Organization (PAHO) $904,000 to develop an information hub for medical products, regulatory processes and systems...

Urovalve Reveals Positive Study Results of Bladder Management System
07 October 2010 Urovalve has revealed clinical study results of its Surinate Bladder Management System, which is designed to improve the quality of life for men with acute or chronic urinary...

Varian and IMRIS to Develop MR-Guided Radiation Therapy System
07 October 2010 Varian Medical Systems and IMRIS have agreed to co-develop an MR-guided radiation therapy system to treat cancer. The companies will develop the new system by combining IMRIS' MRI...

Ciba Vision Recalls Contact Lenses
07 October 2010 Ciba Vision has issued a recall of all Softperm daily wear contact lenses manufactured after 13 March 2009, according to a release from the UK Medicines and Healthcare products Regulatory Agency. ...

NovaBone Receives FDA Approval for Bone Graft Delivery System
07 October 2010 NovaBone Products has received US Food and Drug Administration (FDA) approval for its NovaBone Putty MIS delivery system, which improves the delivery of bone grafting material in minimally...

Fluorescent Beads Could End Finger Prick Blood-Sugar Testing
06 October 2010 Biocompatible beads that glow in response to heightened blood-sugar levels could replace painful finger prick blood tests for diabetics, according to Japanese scientists. Researchers at...

Synthes to Pay $23m Fine for Unapproved Bone Cement Trials
06 October 2010 Medical device company Synthes has agreed to pay a $23m fine for illegally testing bone cement in 200 spinal patients, resulting in three deaths. Norian, a unit of Synthes, conducted...

Diagnostic X-Rays Found to Increase Childhood Leukaemia Risk
06 October 2010 Exposure to diagnostic X-rays can increase the risk of childhood leukaemia, according to researchers at the University of California Berkeley School of Public Health. Researchers enrolled...

Deep Brain Stimulation Could Be Used to Treat OCD
06 October 2010 Deep brain stimulation could help patients with obsessive compulsive disorder, according to research conducted at Amsterdam University's Academic Medical Center. Sixteen patients with...

US Inspectors Reopen Investigation into FDA-Approved Medical Scanners
05 October 2010 Federal inspectors in the US have reopened an investigation into claims that US Food and Drug Administration (FDA) scientists were pressurised to approve certain medical scanners by...

New Laser Technique Could Reduce Surgery Scars
05 October 2010 Researchers at the University of Toronto and Hospital for Sick Children, Canada, have developed a laser technique that can reduce scarring after surgery. The Picosecond IR Laser...

Wenzel Receives FDA Approval for Intervertebral Body Fusion System
05 October 2010 Wenzel Spine has received 510(k) approval from the US Food and Drug Administration (FDA) for its VariLift standalone expandable interbody fusion system for the treatment of degenerative...

Tyton Reveals Positive Study Results for Stent System
05 October 2010 Tyton has revealed positive interim six-month results for its side-branch stent system, which is used for the treatment of atherosclerosis. In a study involving 253 patients, the...

St Jude Spinal Cord Stimulation System Approved in Japan
04 October 2010 St Jude Medical has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare for Eon Mini, its spinal cord stimulation system for the management of chronic...

Dual-Platform Technique Improves Circulating Tumour Cell Detection
04 October 2010 Researchers at On-Q-ity have developed a dual-platform technology that improves the detection circulating tumour cells (CTC) in breast cancer patients. The On-Q-ity Circulating Cancer...

New Breath Test Could Diagnose Cancer and Diabetes
04 October 2010 Researchers from Stony Brook University in the US have developed a new sensor nanotechnology that could let doctors diagnose diseases such as diabetes and lung cancer from breath sample. ...

Sysmex Awarded US Army Contract for Haematology Analysers
04 October 2010 Sysmex has been awarded a BPA equipment purchase contract agreement to supply medical haematology analysers to the US Army Medical Material Agency. The contract also requires Sysmex to...

ArthroCare Vertebral Augmentation Device Approved in US
01 October 2010 ArthroCare has received US Food and Drug Administration approval for its Parallax Contour vertebral augmentation device, which is used for the treatment of vertebral compression fractures. ...

Cleft Lip and Palate Device Could Reduce Need for Surgery
01 October 2010 A device that could save children with a cleft lip and palate from invasive jaw widening surgery as an adult has been developed at the University of Alberta, Canada. The device works by...

Researchers Develop Blood Test for Colon Cancer
01 October 2010 Researchers from Danish biotech company Exiqon have developed a blood test for colon cancer that could be used as an initial screening tool prior to colonoscopy. The test works by measuring...

Microelectronic Device Could Reverse Brain Damage
01 October 2010 Researchers are developing a microelectronic device that could help trauma victims regain movement by promoting the growth of damaged neurons in the brain. The device works on the...

September 2010

Top

Microfluidic Device Developed to Identify Aggressive Breast Cancers
30 September 2010 Researchers at the University of South Australia have developed a disposable device that can identify aggressive breast cancers. Patients with aggressive breast cancers have abnormal levels...

CT Scans Could Predict Future Cardiovascular Risk
30 September 2010 Incidental findings from routine CT scans can be helpful in identifying a patient's cardiovascular risk, according to a study from University Medical Center Utrecht in the Netherlands. ...

Intrauterine Devices Successfully Used to Treat Endometrial Cancer
30 September 2010 Intrauterine devices (IUDs) designed to release hormones can be used to treat endometrial cancer, according to a study published in Annals of Oncology. The researchers enrolled 39 patients...

Prostate Cancer Blood Test Could Prevent Unnecessary Biopsies
30 September 2010 Researchers at Oxford Gene Technology have developed a blood test that can distinguish prostate cancer from healthy tissue and benign prostate conditions. The test is based on detecting...

Progenika Receives CE Mark for Lipoprotein Lipase Deficiency Test
29 September 2010 Progenika Biopharma has received the CE mark for LPLchip, a test for the rapid diagnosis of lipoprotein lipase deficiency (LPLD). LPLchip is the first DNA chip that is able to detect...

Johnson & Johnson Acquires Micrus Endovascular
29 September 2010 Johnson & Johnson has completed its acquisition of Micrus Endovascular, a manufacturer of minimally invasive devices for ischaemic and haemorrhagic stroke. Micrus Endovascular will...

Laser-Based Devices Could Replace X-Rays in Disease Diagnosis
29 September 2010 Portable devices that use laser beams may soon replace X-rays in the diagnosis of breast cancer, tooth decay and bone diseases. These devices work on the principle of Raman spectroscopy,...

Study Warns of Imaging Risks in Child Cancer Patients
29 September 2010 The medical imaging tests used children's cancer treatment can expose them to worrying levels of radiation, according to a study conducted at the Hospital for Sick Children in Toronto,...

Latin America's Aortic Stent Graft Market to Reach $150m by 2015
28 September 2010 The aortic stent graft market in Latin America is estimated to reach $150m by 2015, according to a report by the Millennium Research Group. Aortic stent grafts, which are used for...

Chronic Sinusitis Can be Safely Treated in Clinics, Study Finds
28 September 2010 Balloon dilation for chronic sinusitis (CRS) can be safely performed in a clinic, according to a study by Entellus Medical. The study enrolled 71 patients, where 19 patients underwent...

FDA Supports Rollout of Hologic Mammography System
28 September 2010 The US Food and Drug Administration (FDA) Radiological Devices Panel has unanimously voted in favour of the rollout of Hologic's Selenia Dimensions 3D, a digital mammography tomosynthesis system. ...

Insulin Pump Improves Diabetes Control, Says Study
28 September 2010 A blood-sugar sensor and insulin pump can help patients with type I diabetes control their condition more effectively than multiple daily insulin injections, according to a study published in...

Blood Test Could Predict Transplant Organ Rejection
27 September 2010 Researchers at Stanford University in the US have developed a simple and inexpensive blood test that can detect whether the body will reject a transplanted organ. The researchers evaluated...

Edwards Announces Transcatheter Heart Valve Trial Results
27 September 2010 Edwards Lifesciences Corporation has announced that its Sapien transcatheter heart valve, a treatment for patients with severe aortic stenosis, has performed well in a clinical trial. The...

Protectus Granted US Patent for Safety Syringe
27 September 2010 Protectus Medical Devices has been awarded a US Patent for its safety syringe, which is designed to protect doctors and healthcare workers from needlestick injuries. The...

Medical Electrodes Market to Reach $976m by 2015
27 September 2010 The global market for medical device electrodes is estimated to reach $976m by 2015, according to a report by Global Industry Analysts. The US and Europe will account for more than 70% of...

Researchers to Develop Emergency Care Device for Astronauts
24 September 2010 Engineers have begun work on a system that can provide medical care to astronauts while in space, using funds from the US National Space Biomedical Research Institute. The system will combine...

MRIs Could Be Used for Endovascular Stent Surveillance
24 September 2010 MRI scans can be used for the routine surveillance of great vessel stents, according to a study published in the American Journal of Roentgenology. Endovascular stents can imaged using...

Prolapse Repair System Proves Efficacy in Trial
24 September 2010 American Medical Systems has announced positive study results for its Elevate apical and posterior prolapse repair system, a device to treat apical and posterior defects in women. ...

Abbott Mitral Valve System Passes Trial
24 September 2010 Abbott Laboratories' MitraClip System has exhibited clinical benefits in a study sponsored by the Cardiovascular Research Foundation. The randomised, multi-centre and prospective...

Trial Proves Biodegradable Polymer Stents Safe and Effective
23 September 2010 A three-year study at Shenyang Northern Hospital in China has shown that biodegradable polymer-based sirolimus eluting stents have satisfactory clinical and safety outcomes. The CREATE...

Scientists Develop New Breast Cancer Marker
23 September 2010 Researchers at the University of California, San Diego, have developed a new material that could help surgeons to locate breast cancers, reducing the need for second surgeries. The...

Bioconnect Receives CE Mark for Optiflow Vascular Anastomotic System
23 September 2010 Bioconnect Systems has received CE mark approval for its Optiflow Vascular Anastomotic System, which is used to create vascular access in haemodialysis patients. The system enhances...

Zynex to Develop Central Blood Volume Monitoring Device
23 September 2010 Zynex has announced that it is developing a device to monitor central blood volume. The device, currently in engineering and prototyping phase, is intended for use in operating and...

Medtronic Integrity Stent Receives FDA Approval
22 September 2010 Medtronic has received US Food and Drug Administration (FDA) approval for its Integrity Coronary Stent System for the treatment of coronary heart disease. The system is based on...

Corindus Coronary Intervention System Performs Well in Trials
22 September 2010 Corindus Vascular Robotics has revealed positive study results for their CorPath 200 System, which is used to deliver and manipulate coronary guidewires and stent / balloon systems in...

Scientists Develop Blood Test for Fatty Liver Disease
22 September 2010 Scientists from the Basque Center for Cooperative Research in Biosciences (CIC bioGUNE) and OWL Genomics have developed a blood test for non-alcoholic fatty liver disease. Non-alcoholic...

New Test Could Predict Diabetes Onset
22 September 2010 Researchers have developed a blood test that can detect and predict the onset of diabetes by measuring levels of microRNA. Researchers analysed the blood samples in a Bruneck study,...

Neurostimulation Shows Promise for Migraine Treatment
21 September 2010 Medtronic has revealed positive results from a trial to test occipital nerve stimulation for the treatment of chronic migraines. The randomised and blinded trial was conducted across...

Scientists Unveil Artificial Pancreas
21 September 2010 An artificial pancreas that could revolutionise diabetes treatment has been developed at De Montfort University in the UK. The device consists of a metal casing, which contains insulin, and...

Elixir Launches Coronary Stent Trial
21 September 2010 Elixir Medical Corporation has initiated a randomised clinical trial to evaluate its DESyne BD Stent, a novolimus-eluting coronary stent system with a bio-absorbable coating. The trial...

Scientists Test Body-Powered Fuel Cell
21 September 2010 A fuel cell battery that could potentially be powered by natural body processes has been developed by scientists from the Université Joseph Fourier in Grenoble, France. The implantable...

Robotic Heart Catheter Could Improve Atrial Fibrillation Treatment
20 September 2010 Researchers at North Carolina State University have developed a computerised robotic catheter that could make atrial fibrillation treatment faster, cheaper and more effective. ...

ResMed CPAP Device Performs Well in Clinical Study
20 September 2010 ResMed has announced that its new CPAP device significantly increased compliance with sleep therapy in sleep apnoea patients during a clinical trial. The trial involved 50 patients with...

Stenting for Aortic Coarctation has 77% Success Rate
20 September 2010 Long-term stenting for aortic coarctation is successful in three quarters of cases, a study by the Congenital Cardiovascular Interventional Study Consortium has found. Aortic...

HPA Develops Bacterial Meningitis Test
20 September 2010 A tool that can rapidly identify bacterial meningitis has been developed by researchers at the UK's Health Protection Agency (HPA). Researchers analysed 385 confirmed cases of meningitis over...

Scientists Unveil One-Hour TB Test
17 September 2010 UK Health Protection Agency (HPA) scientists have developed a test that can identify positive tuberculosis cases within one hour. The single DNA molecule identification test uses the...

Medicare Bidding Programme Could Reduce Equipment Quality
17 September 2010 A competitive bidding programme for durable medical equipment set to be launched in the US could limit access to home medical equipment and reduce the quality of products, according to a...

Neuroimaging Could Aid Early Diagnosis of Parkinson's
17 September 2010 Neuroimaging techniques can be used to predict if people with REM sleep disorder will develop neurological disorders such as Parkinson's disease, according to a study published in ...

Implant Developed to Treat Hypertension and Heart Disease
17 September 2010 The first implantable device that can treat both hypertension and cardiovascular disease has been developed by Minneapolis-based CVRx, using wireless radio technology provided by...

Ranier Receives CE Mark for Spinal Disc Replacement Device
16 September 2010 Ranier Technology has received the CE mark for Cadisc-L, a spinal disc replacement device for the lumbar spine. Cadisc-L is indicated for the treatment of degenerative disc disease,...

Study Authors Often Fail to Disclose Device Manufacturer Payments
16 September 2010 More than half of the payments made by orthopaedic device companies to surgeons in the US were not disclosed in journal articles, according to a study published in Archives of Internal Medicine. ...

PSA Blood Test Could Determine Prostate Cancer Death Risk
16 September 2010 A single blood test to measure prostate-specific antigen (PSA) levels can determine if men aged 60 and above are at the risk of dying from prostate cancer, according to a study published in...

Shape Memory Alloys Proven to be Biocompatible
16 September 2010 The shape memory alloys (SMAs) used in medical devices and implants are biocompatible and should not cause medical problems, according to a study from the University of Maribor, Slovenia. ...

Brain Stimulation Can Help Stroke Patients Regain Motor Function
15 September 2010 Non-invasive brain stimulation can be used to improve the motor function of stroke patients who are partially paralysed, according to a study from Ain Shams University in Cairo,...

Researchers to Develop Blood Test for Pre-Eclampsia
15 September 2010 Researchers are developing a new blood test that can predict a woman's risk of pre-eclampsia, a life-threatening condition that can occur during pregnancy. An international team of...

Blood Serum Biomarkers Used to Detect Alzheimer's
15 September 2010 Protein-based blood serum biomarkers can be used to detect Alzheimer's disease, according to a study from the Texas Tech University Health Sciences Center and Texas Alzheimer's Research...

Fibre Optic Link Could Offer New Hope for Amputees
15 September 2010 A research team led by engineers from Southern Methodist University is developing a fibre optic link to allow communication between prosthetic limbs and the brain, providing new hope for amputees....

Routine Re-Siting of Peripheral IVDs May Not Cut Complications
14 September 2010 Routine re-siting of a peripheral intravenous device (IVD) may not reduce complications, according to a study published in journal BioMed Central. Current recommendations are that...

Avinger Initiates Peripheral Artery Disease Catheter Trial
14 September 2010 Avinger has initiated a trial of its Wildcat catheter, a device to treat chronic total occlusion (CTO) lesions in patients with peripheral artery disease. The catheter is designed to cross...

California Law Could Protect Patients from Medical Radiation
14 September 2010 A proposed bill in California, US, could protect patients from dangerous levels of radiation from imaging devices such as CT scanners. The bill, which is awaiting the governor's signature,...

GI Dynamic's Gastrointestinal Liner Performs Well in Trial
14 September 2010 GI Dynamics has announced positive results from a 12-month study of its EndoBarrier gastrointestinal liner, a non-surgical treatment for obesity and diabetes. The liner is placed in...

VirtualScopics and ABX-CRO Form Molecular Imaging Partnership
13 September 2010 VirtualScopics has entered into a scientific collaboration with ABX-CRO to use molecular imaging for the study of new drugs and medical devices. The partnership will provide an...

New Rules Will Force Chinese Medical Device Manufacturers to Report Faults
13 September 2010 Medical equipment manufacturers in China will have to report any faults associated with their products, according to draft regulations issued by the Chinese Government. The new monitoring...

Teleflex Receives FDA Approval for its Central Catheter
13 September 2010 Teleflex has announced that it has received 510(k) approval from the US Food and Drug Administration (FDA) for its ArrowEVOLUTION PICC with Chlorag+ard technology. The device is a...

AtheroMed Initiates Atherectomy Catheter Trial
13 September 2010 AtheroMed has started to enrol patients for a clinical trial of its Phoenix atherectomy catheter, a device to treat peripheral arterial disease in the legs. The FDA-approved...

New Algorithm Could Improve Breast Cancer Imaging
10 September 2010 Researchers at the University of Cordoba, Argentina, have found a way to improve the image quality of X-ray mammography, which could help to reduce false results when screening for breast cancer. ...

Researchers Develop Titanium Foam for Bone Implants
10 September 2010 Researchers at the Fraunhofer Institute for Manufacturing and Advanced Materials in Dresden have developed a titanium "foam" that could bring about a new generation of titanium implants. ...

WHO Warns of Major Medical Device Gaps in the Developing World
10 September 2010 Developing countries have limited access to medical devices despite the quantity and variety available worldwide, according to a World Health Organization (WHO) study. The findings...

Pulse Device Prevents Sleep Apnoea and Snoring
10 September 2010 US-based Apnex has developed a device that prevents snoring and sleep apnoea by stimulating a tongue muscle with electrical pulses. Sleep apnoea, the most common cause of snoring, occurs...

Johnson & Johnson Sued Over Hip Replacement Device
09 September 2010 Johnson & Johnson has been sued by a Californian construction worker over its ASR Hip Resurfacing system, which was recalled in August 2010 due to design defects. The lawsuit, filed in...

Recalled Breast Implants Show No Evidence of Health Risks
09 September 2010 Tests on a type of breast implant that contain an unapproved gel have found no evidence that they are unsafe, according to researchers in the UK. The Poly Implant Prostheses...

Researchers Use Electrical Stimulation to Treat Depression
09 September 2010 Researchers at University of California, Los Angeles in the US have developed a technique known as trigeminal nerve stimulation, which applies electrical stimulation to a major nerve...

Researchers Develop Blood Test for Respiratory Viral Infections
09 September 2010 A blood test that can accurately and rapidly diagnose respiratory viral infections has been developed by a research team from Duke Institute for Genome Sciences & Policy and Duke...

Myconostica Receives CE Mark for Aspergillus Test
08 September 2010 Myconostica has received European CE mark approval for its MycAssay Aspergillus, a molecular diagnostic test that can detect Aspergillus infections from a serum sample. The test detects...

Ascension's Total Shoulder System Receives FDA Approval
08 September 2010 Ascension Orthopaedics has received approval from the US Food and Drug Administration (FDA) for its TITAN Modular Total Shoulder System, an implant system that offers multiple surgical options...

Study Finds PET/CT Scans Effective at Detecting Breast Cancer Metastases
08 September 2010 A study has found that PET/CT scanning might be more effective at detecting breast cancer that has spread to bones than CT plus bone scans. Researchers at the Memorial Sloan-Kettering...

Scientists Develop Handheld MRSA and Breast Cancer Test
08 September 2010 Scientists have developed a handheld device that can rapidly detect diseases such as breast cancer and MRSA. The device, known as CliniHub, has four ports that contain a chemical assay...

UCSF Researchers Develop First Implantable Artificial Kidney
07 September 2010 The first implantable artificial kidney has been developed by researchers from the University of California, San Francisco (UCSF), who hope the device may eliminate the need for dialysis in...

Unilife Receives FDA 510(k) Approval for Tuberculin Syringe
07 September 2010 Unilife Corporation has announced that it has received a 510(k) approval from the US Food and Drug Administration for its Unitract Tuberculin Syringe. The syringe allows operators to control...

Plate and Screw Market in Japan to Exceed $170m by 2014: Report
07 September 2010 The Japanese medical plate and screw market, driven by surgeon acceptance, is forecast to grow to over $170m by 2014, according to a report from Millennium Research Group (MRG). According...

IMEC to Develop Lab-on-Chip Cancer Device
07 September 2010 IMEC has announced the launch of the MIRACLE project to develop a lab-on-chip device to help create a rapid and cost-efficient device to detect cancer. The device will work by isolating...

Researchers Develop Miniature Pump for Microneedle Drug Patches
06 September 2010 Purdue University researchers have developed a miniature pump to be used with microneedle drug-delivery patches, which can improve the delivery of medication into the skin. ...

New Rapid Test for Developed TB
06 September 2010 A new test developed by Cepheid can detect tuberculosis (TB) and diagnose the drug-resistant form within hours, a new study has found. In a study of 1,730 patients, Cepheid's GeneXpert...

New Diabetes Test May Not Be Effective
06 September 2010 A proposed diabetes test known as A1c can miss millions of diabetes cases and may over-diagnose black Americans, according to a new study. In the study, researchers tested 5,000 Americans...

Medical Devices Market in Emerging Superpowers Exceeds $10bn
06 September 2010 The medical devices market in Brazil, Russia, India and China is worth approximately $10.8bn, a new report has said. The Marketresearch.com report, "The Market for Medical Devices in...

Quidel's Pregnancy Test Receives FDA 510(k) Clearance
03 September 2010 Quidel Corporation has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for RapidVue hCG, its new pregnancy test. RapidVue hCG is a lateral...

Prometheus Introduces Crohn's Prognostic Test
03 September 2010 Prometheus Laboratories has launched the first serogenetic test that can predict a patient's risk of developing Crohn's disease complications. Prometheus's Crohn's prognostic test uses...

Masimo PVI Improves Fluid Management During Surgery
03 September 2010 A randomised controlled trial has shown that use of the Masimo pleth variability index (PVI) significantly improves fluid management and reduces the lactate levels in patients during and...

New Device Helps Bilateral Hearing
03 September 2010 A new electronic device, the first of its kind that requires only one implant to improve bilateral hearing, has been used in an operation at the South of England Cochlear Implant Centre (SOECIC)...

Newer Generation Drug Eluting Stents Effective: Study
02 September 2010 Newer generation everolimus-eluting stents provide greater therapeutic benefit when compared to early generation sirolimus-eluting stents, according to results from a long-term study. ...

Scientists Develop Rapid Neutrophils Isolating Device
02 September 2010 Scientists from Massachusetts General Hospital (MGH) have developed a new microfluidic device that can rapidly and accurately isolate neutrophils, an innovation that can help in...

Researchers Develop MRI Technique to Record Moving Joints and Organs
02 September 2010 Max Plank researchers from Göttingen have developed a new magnetic resonance imaging (MRI) technique that can capture live recordings of moving joints and organs. To develop the technique,...

African-Americans at High Risk of Blood Clots from Drug-Eluting Stents
02 September 2010 African-Americans who receive drug-eluting stents are at a high risk of developing life-threatening blood clots, according to new research reported in Circulation: Journal of the American...

Magnetic Resonance Spectography Could Detect Neurological Disorders
01 September 2010 Magnetic Resonance Spectography (MRS) can distinguish between different types of neurological degenerative disorders, according to a study conducted by University of Minnesota...

Forceps Delivery Increases the Risk of Muscle Damage
01 September 2010 Using forceps to help deliver a baby can increase the risk of levator ani muscle damage, which can later lead to pelvic organ prolapse, according to a study by researchers from the University...

Researchers Develop Plastic Microneedles That Could Help Diagnose Cancer
01 September 2010 Researchers from North Carolina State University have developed plastic microneedles that can deliver nanoscale dyes known as quantum dots into the skin, an innovation that could help in...

Scientists Use Biosynthetic Corneas to Restore Eyesight
01 September 2010 Scientists from Canada and Sweden have successfully used biosynthetic corneas to restore patients' eyesight in a human trial. The biosynthetic implants were developed using recombinant...

August 2010

Top

Johnson & Johnson Recalls Contact Lenses
31 August 2010 Johnson & Johnson has recalled about 100,000 boxes of its 1-Day Acuvue TruEye contact lenses in Japan, Europe and Asia due to customer complaints. The company said that customers...

Nuclear-Based Breast Imaging Exams Increase Cancer Risk
31 August 2010 Nuclear-based breast imaging exams such as single breast-specific gamma imaging (BSGI) or positron emission mammography (PEM) may increase a woman's risk of developing radiation-induced...

Echo Therapeutics Completes Clinical Trial of its Skin Prep Device
31 August 2010 Echo Therapeutics has announced the completion of a clinical study of its Prelude SkinPrep System, which is used for transdermal drug delivery. Prelude is a handheld device that prepares...

Taiwanese Researchers Develop Pen-Sized Sterilisation Device
31 August 2010 Researchers from National Cheng Kung University, Taiwan, have developed a pen-sized device that can sterilise medical instruments and wounds. The device works on the principle of...

Intra-Aortic Balloon Pumps May Not Reduce Adverse Cardiac Events
27 August 2010 Intra-aortic balloon pumps (IABPs) may not significantly lower the rate of adverse cardiac events when given to high-risk patients before percutaneous coronary interventions, according to...

Researchers Develop LED-Based Diagnostic Device
27 August 2010 Arizona State University researchers have developed a diagnostic device that uses LEDs and microelectronic amplifiers to detect diseases. Integrascope can analyse patient fluid samples...

ConvaTec's Continence Control Device Receives EU Approval
27 August 2010 ConvaTec's Vitala continence control device has been granted the CE mark for 12-hour daily use with a convex skin barrier. Vitala is a pouchless and non-invasive device that provides...

FDA Warns Johnson & Johnson Over Product Marketing
27 August 2010 The US Food and Drug Administration (FDA) has issued a warning to DePuy Orthopaedics, a unit of Johnson & Johnson, concerning products that are being sold without pre-marketing approval...

Sirtex's Colorectal Cancer Microspheres Prove Effective
26 August 2010 Sirtex has announced that its radioactive yttrium-90-labelled resin microspheres appear to be a safe and effective treatment for patients with colorectal cancer liver metastases who have...

Researchers Develop Construct That Prolongs the Life of Implants
26 August 2010 Researchers from the University of Louisville / Jewish Hospital Cardiovascular Innovation Institute have developed a microvascular construct that can prolong the life of implanted...

Benvenue Begins Osteoporotic Fracture Implant Trials
26 August 2010 Benvenue Medical has enrolled the first patient in the clinical study of its Kiva implant, which is used for the treatment of painful osteoporotic fractures. The randomised trial will...

Radiometer Blood-Gas Analyser Receives FDA Approval
26 August 2010 Radiometer America has been granted 510(k) approval by the US Food and Drug Administration (FDA) for ABL90 FLEX, its cassette-based blood-gas analyser. ABL90 FLEX is designed for...

New Technique Can Reduce Radiation Doses in CT Scans
25 August 2010 Adaptive statistical iterative reconstruction (ASIR) can reduce the radiation dose involved in abdominal computed tomography (CT) scans by between 23% and 66%, according to a study published in...

Iridex Granted US Patent for Dose Control Laser System
25 August 2010 Iridex Corporation has been awarded a US Patent for its MicroPulse technology, which gives ophthalmologists fine dose control of laser energy during eye surgery. This patent applies to...

CTC Effective at Detecting Extracolonic Lesions
25 August 2010 Computed tomography colonography (CTC) doubles the detection rate of lesions outside of the colon, according to a study published in the American Journal of Roentgenology. CTC is an...

Genetic Test Could Herald TB Breakthrough
25 August 2010 Scientists are getting closer to developing a genetic blood test that could determine whether a patient carrying latent form tuberculosis (TB) will develop full-blown TB. Researchers...

OJ-Bio to Develop Rapid Chlamydia Detection Device
24 August 2010 Researchers at OJ-Bio are developing a portable wireless device that can rapidly detect sexually transmitted diseases such as chlamydia. The handheld device will identify the protein markers...

Binder Biomedical Introduces Spinal Spacer System
24 August 2010 Binder Biomedical has announced the launch of NEWTON, its intervertebral body fusion spinal spacer system. The system consists of an entire line of lumbar spacers, which allow surgeons to...

Researchers Develop Protein Coating That Improves Implant Adhesion
24 August 2010 Researchers from Georgia Tech Institute of Technology in the US have developed a coating that can strengthen the bond between titanium joint replacement implants and a patient's bone. ...

Biodegradable Implant Could Treat Retinal Vein Occlusion
24 August 2010 A biodegradable implant that is injected into the back of the eye could be used to treat retinal vein occlusion, a condition that causes vision loss. Ozurdex is inserted near the retina...

Drug-Eluting Stents Improve Clinical Outcomes, Says Study
23 August 2010 Drug-eluting stents improve long-term clinical outcomes for patients undergoing angioplasty, according to a study conducted at Rabin Medical Center in Israel. Researchers evaluated the...

Gender-Specific Knee Implants No Better Than Standard Prostheses
23 August 2010 Gender-specific total knee prostheses do not offer women any clinical benefits when compared with standard prostheses, according to a recent study in Bone and Joint Surgery. The study...

Scientists to Develop Foetal Surveillance System
23 August 2010 Scientists from the University of Ulster, Queen's University Hospital and the Royal Jubilee Maternity Hospital are developing a foetal surveillance system to alert doctors if a baby is at risk...

Researchers Develop Imaging Technology for Heart Rhythm Disorder
23 August 2010 Researchers at the University of Maryland School of Medicine in Baltimore have developed a 3D imaging technology that could improve the treatment of ventricular tachycardia. The 3D...

Researchers Develop One-Hour Meningitis Test
20 August 2010 Researchers in Northern Ireland have developed a groundbreaking test for meningococcal meningitis that can detect the disease in one hour. Loop-mediated isothermal amplification (LAMP), uses...

Brain Cooling System Could Reduce Brain Damage
20 August 2010 A portable system that cools the brain via the nasal cavity could increase the survival rate of people who have had a heart attack, according to a study. The RhinoChill Intra-Nasal...

Maths Formula Could Lead to Lung Scanning Technology for Newborns
20 August 2010 Researchers from Middlesex University have helped to develop a mathematical formula that can be used to create images from electrical impedance tomography (EIT) scans. The breakthrough will...

BSD Receives FDA Clearance for Microwave Ablation System
20 August 2010 BSD Medical Corporation has received 510(k) clearance from the US Food and Drug Administration (FDA) for its MicroThermX Microwave Ablation System (MTX-180), which uses microwave energy to...

Researchers Develop Device to Visualise Coronary Artery Plaques
19 August 2010 A new method of detecting coronary artery plaques that are vulnerable to rupture has been developed in the US, and could be used to help diagnose patients with cardiovascular disease...

Laser Discovery Could Lead to New Pacemakers
19 August 2010 Scientists have found that pulsed light from a laser can be used to pace contractions in an avian embryonic heart, a discovery that could lead to a new generation of pacemakers. Pulsed...

Balloon Implant Could Prevent Prostate Cancer Treatment Side Effects
19 August 2010 Scientists have developed a balloon implant that can prevent incontinence, impotence and loss of libido associated with prostate cancer treatment. Prostate cancer treatment, which...

FDA Recalls St Jude Medical Engage Introducer Devices
19 August 2010 The US Food and Drug Administration (FDA) has issued a Class I recall for several batches 6 French (6F) Engage Introducer devices manufactured by St Jude Medical. The recall affects more...

New Optical Imaging Technique to Improve Angioplasty
18 August 2010 A new optical imaging technique combining optical coherence tomography with a balloon deployment system can improve angioplasty procedures, according to a study published in Review of...

Researchers Develop Implantable Silk Metamaterials
18 August 2010 Researchers at the Tufts University School of Engineering and Boston University have developed metamaterial structures patterned on implantable silk substrates, which could be helpful in...

Harvard Researchers Develop New Cell-Probing Device
18 August 2010 Chemists and engineers at Harvard University have designed a new type of V-shaped transistor, called nanoFETs, which can be used to sensitively probe cell interiors. Existing probes are...

Benvenue Announces First Clinical Use of its Vertebral Augmentation System
18 August 2010 Benvenue Medical has announced the completion of the first surgery in the US involving its Blazer Vertebral Augmentation System, which is used for the treatment of vertebral compression fractures....

BioGenerator Leads Funding for Clot-Destroying Technology
17 August 2010 BioGenerator, an economic development funding group, has led an early round of financing for Pulse Therapeutics, a developer of magnetism-based technology to destroy blood clots related...

International Project to Develop Inexpensive Blood Test
17 August 2010 Dublin City University is coordinating a €3m international project to develop a new type of blood test. The device will be disposable, and only need a pin-prick blood sample to...

Zimmer Announces First Periprosthetic Implantation
17 August 2010 Zimmer has announced the first implantation of the Zimmer Non-Contact Bridging (NCB) Periprosthetic Plating System, which is designed for femoral fractures that occur around a hip or knee implant....

Contact Lens Wearers at Higher Risk of Corneal Ulcers
17 August 2010 Contact lens wearers are more likely to develop corneal ulcers than non-wearers, according to research published in Archives of Ophthalmology. The research looked at nearly 1.1 million...

Antibacterial IV Connector Given FDA Clearance
16 August 2010 Bacterin International Holding and RyMed Technologies have received US Food and Drug Administration (FDA) clearance to commercialise their InVision-Plus CS needleless IV connector. The...

Researchers Develop Breath-Based Cancer Detection Device
16 August 2010 Researchers in Israel have developed a device that can detect cancer by analysing a patient's breath. The device uses sensors involving gold nanoparticles to detect chemicals that are...

Protectus Syringe Offers Protection from Needlestick Injuries
16 August 2010 Protectus Medical Devices has developed a syringe that can protect healthcare workers from needlestick accidents when they administer injections. The patented syringe has a...

Nanodiamond Coating Could Prolong Life of Joint Replacement Devices
16 August 2010 Researchers at a US university have developed a nanodiamond coating that can prolong the life of joint replacement devices. Knee and hip replacements usually last around ten years,...

Tissue Regenix Receives CE Mark for dCELL Vascular Patch
13 August 2010 Tissue Regenix has received European CE mark approval for its dCELL vascular patch. The patch is a non-cellular, sterile scaffold designed to be permanently implanted into a patient for...

MIT Makes Progress on Light-Based Blood-Glucose Monitor
13 August 2010 Researchers at MIT's Spectroscopy Laboratory are developing a light-based device that can help people with type I diabetes to measure their blood-glucose levels without skin pricking. ...

UK Researchers Develop Brain Scan That Can Detect Autism
13 August 2010 Researchers at the Institute of Psychiatry at King's College London, UK, have developed a brain scan that can detect autism with 90% accuracy. The technique was tested in a study involving...

Sheffield Researchers Develop Painless Oral Cancer Test
13 August 2010 Researchers at the University of Sheffield, UK, are developing a painless oral cancer test that can deliver results within eight to ten minutes. The test involves collecting cells from...

FDA Warns Against Extended Use of Retrievable IVC Filters
12 August 2010 The US Food and Drug Administration (FDA) has recommended that clinicians remove retrievable inferior vena cava (IVC) filters as soon as the risk of blood clots has subsided. IVC filters...

CryoLife Cardiac Patch Granted Shelf-Life Extension
12 August 2010 CryoLife has received 510(K) clearance from the US Food and Drug Administration for a five-year shelf-life for its CryoPatch SG pulmonary human cardiac patch. CryoPatch is used in...

BioVentrix Announces Milestone for PliCath HF System
12 August 2010 BioVentrix has announced a first-in-man milestone for its PliCath HF System following the completion of an epicardial catheter-based ventricular reconstruction in a 52-year-old male heart...

Tissue Regenix Granted Patents for the Ultrasonic Modification of Matrices
12 August 2010 Tissue Regenix has been granted two patents in the US and Australia relating to the ultrasonic modification of matrices. Ultrasonic modification of matrices is a method of using...

Aptus EndoStapling System Used to Treat Aortic Aneurysms in Europe
11 August 2010 Aptus Endosystems has announced that several patients in Europe with aortic aneurysm disease have been successfully treated using its Aptus EndoStapling System. The Aptus EndoStapling...

Laser Prostate Cancer Surgery Could Reduce Side Effects
11 August 2010 Prostate cancer surgery using robotic instrumentation and laser technology may preserve the sensitive nerve areas necessary for urinary continence and erections, according to new research. ...

Deep Brain Stimulation May Slow Alzheimer's Progression
11 August 2010 Deep brain stimulation could help slow down the progression of Alzheimer's disease, according to a new study. The Phase I trial saw electrodes implanted into the hippocampus region of the...

Implantable Defibrillator May Prevent Heart Attacks
11 August 2010 Scottsdale Healthcare in Arizona, US, is testing an implantable device that could prevent cardiac arrests by using electrical impulses to interrupt fatal heart rhythms and restore normal...

Partnership to Use Genomic Analysis in Lymphocytic Leukaemia Study
10 August 2010 Life Technologies Corporation and Moores Cancer Center at the University of California, San Diego, have come together to use SOLiD 4 genomic analysis to study chronic lymphocytic...

Researchers Develop Cancer Detecting Laser
10 August 2010 Researchers at the University of California, Davis, have developed a laser probe that can identify early-stage oral cancer and locate tumour edges during surgery. The probe stimulates...

MicroVention Announces Positive Cerebral Aneurysm Device Trial Data
10 August 2010 MicroVention has announced positive 18-month follow-up data from an international study, which shows that the HydroCoil Embolic System improved outcomes in treating cerebral aneurysms when...

Medtronic Enrols First Patient on Aortic Dissection Trial
10 August 2010 Medtronic has enrolled the first patient on a trial to evaluate the clinical performance of the Valiant Thoracic Stent Graft with the Captivia Delivery System for the treatment of type B...

Genetic Testing Companies to Face Restrictions
09 August 2010 Companies that offer genetic tests for certain diseases are to face restrictions to stop them from providing inaccurate information. Genetic testing companies calculate the risk of disease...

Life Technologies Launches DNA Extraction System
09 August 2010 Life Technologies has announced the commercial availability of its AutoMate Express Forensic DNA Extraction System. Automate Express is used to streamline sample preparation and...

Australian Doctors Perform Gamma Knife Treatment
09 August 2010 The first gamma knife treatment in Australia has been carried out at Macquarie University Hospital in Sydney. The gamma knife uses low-intensity radiation from cobalt-60 sources to treat...

X-Ray Crystallography Used to Capture New Antibiotic Activity
09 August 2010 Researchers at GlaxoSmithKline have used X-ray crystallography to demonstrate how a new type of antibiotic can kill bacteria already resistant to existing drugs. The snapshot shows the...

Australian Doctors Sucessfully Treat Aneurysms With Gore Sheath
06 August 2010 WL Gore & Associates has successfully completed several procedures in Australia using the Gore DrySeal Sheath, which aids in the treatment of abdominal aortic aneurysms and thoracic...

EnteroMedics to Trial Hunger Blocking Device
06 August 2010 EnteroMedics is planning a trial of its VBLOC vagal blocking therapy, after the device received a conditional investigational device exemption from the US Food and Drug Administration. ...

Boston Scientific Begins Patient Enrolment for Coronary Stent Trial
06 August 2010 Boston Scientific has begun enrolling patients in its Evolve clinical trial, which will assess the safety and performance of its latest drug-eluting coronary stent. The Synergy Stent consists...

GE and Intel to Form New Healthcare Company
06 August 2010 GE and Intel are planning to create a company that focuses on assistive technologies, disease management and independent living. The 50/50 joint venture will develop and market...

Wright Medical Group Unveils Medial-Pivot Knee
05 August 2010 Wright Medical Group has launched the Evolution Medial-Pivot Knee System, which is designed to replicate the stability and function of a human knee. The Evolution system has a...

FDA Proposes Changes to 510(k) Approval Process
05 August 2010 The US Food and Drug Administration (FDA) has proposed changes to the 510(k) approval process in an attempt to tighten the regulation of medical devices. Under the plans, the FDA would create...

Microsulis Introduces Microwave Tissue Ablation System
05 August 2010 A microwave tissue ablation system that can destroy tumours has been launched by Microsulis Medical. Accu2i pMTA is a closed water-cooled needle with a 1.8mm diameter. It uses high...

AdvanDx Given FDA Clearance for Candidemia Test
05 August 2010 AdvanDx has received US Food and Drug Administration 510(k) clearance for its Yeast Traffic Light PNA FISH test, which can detect Candidemia in 90 minutes. Candidemia is serious...

Circle Biologics Introduces New Platelet Concentrator Platform
04 August 2010 Circle Biologics has introduced the Autologous Platelet Concentrator Platform (APC), a technological breakthrough in regenerative medicine. The single device platform integrates...

Bluetooth Device Helps Doctors to Monitor Patients' Hearts
04 August 2010 Doctors have begun using a Bluetooth device to monitor patients' heart function remotely. The FDA-approved implant transmits data to doctors from a patient's home, and issues alerts if...

Medtronic to Study Spinal Cord Stimulation as a Heart Therapy
04 August 2010 Medtronic has launched a clinical trial to evaluate the feasibility of using spinal cord stimulation (SCS) to improve the clinical signs and symptoms of heart failure. Heart failure...

Faecal Blood Testing Most Cost-Effective for Colorectal Cancer Screening
04 August 2010 Faecal blood tests are a more cost-effective way to screen for colorectal cancer, according to a study by the researchers at RTI International. Although colonoscopies are more accurate,...

FDA and FCC Join Forces on Wireless Medical Devices Regulation
03 August 2010 The Federal Communications Commission (FCC) and US Food and Drug Administration (FDA) have signed a memorandum of understanding (MOU) to work together to create an efficient regulatory process...

Bioengineers Develop Long-Term Implantable Glucose Sensor
03 August 2010 An implantable glucose sensor that continuously monitors tissue glucose and transmits data wirelessly has been developed by GlySens and the University of California, San Diego. The...

Lab Test Could Predict Imatinib Resistance
03 August 2010 Scientists in Japan have developed a lab test that could predict if a patient will be resistant to imatinib, the standard of care for chronic myeloid leukaemia. The test uses...

New York State Approves Fragile X Syndrome Test
03 August 2010 The XSense test for Fragile X syndrome has been approved by New York State's Department of Health, making the test available to physicians across the US. Fragile X syndrome is a leading...

Akonni Awarded Grant to Develop Hands-Free Tuberculosis Test
02 August 2010 Akonni Biosystems has announced it has received a $435,000 grant to develop a hands-free, sample-to-answer system to identify multi-drug resistant strains of Mycobacterium...

First Da Vinci Robotic Hand Surgery Performed in US
02 August 2010 A revolutionary robotic hand surgery has been performed at Northwest Hospital in Randallstown, Maryland, using the Da Vinci Surgical System. The Da Vinci Surgical System has been...

MabCure Develops Accurate Ovarian Cancer Test
02 August 2010 MabCure has revealed its proprietary monoclonal antibodies successfully identified ovarian cancer in blood with 94% accuracy in a test. In a study involving 54 different blood samples,...

MODS Proves Best for Tuberculosis Detection
02 August 2010 A microscopic-observation drug-susceptibility (MODS) technique that uses gastric aspirate specimens is the best test for high-risk children suffering with tuberculosis, an international team...

July 2010

Top

Glucose Monitoring Market to Exceed $16bn by 2014
30 July 2010 The glucose monitoring devices market is expected to increase to more than $16bn worldwide by 2014, according to a report by Renub Research. The report forecasts that the European...

NCKU Experts Develop Rehabilitation Robots
30 July 2010 Three rehabilitation robots for stroke patients have been developed at Taiwan's National Cheng Kung University (NCKU). The three robots for the upper limbs, lower limbs and ankles...

Nasal Mask Helps Disabled to Control Electronics
30 July 2010 A nasal mask that allows severely disabled people to drive wheelchairs and write text messages by sniffing has been developed by Israeli scientists. The "sniff controller" measures changes...

Prodesse's ProFAST+ Assay Wins FDA Approval
30 July 2010 Gen-Probe Incorporated has announced that Prodesse's ProFAST+ assay has become the first molecular diagnostic test to receive clearance from the US Food and Drug Administration (FDA). The...

Medical Devices Injure 70,000 Children in US Annually
29 July 2010 More than 70,000 children attend emergency rooms each year due to injuries from medical devices, according to researchers from the US Food and Drug Administration (FDA). Contact lenses...

Canadian Researchers Develop Dizziness Device
29 July 2010 A device that helps to alleviate dizziness caused by benign paroxysmal positional vertigo (BPPV) has been developed by Canadian researchers. The device, which attaches to the brim of any...

FDA to Evaluate Medtronic Spinal Fusion Device
29 July 2010 US regulators have warned that Amplify, Medtronic's experimental spinal fusion device, does not work as well after five years as it did after two. After two years, 61% of Amplify surgeries...

Australian Nano-Patch Could Replace Syringes
29 July 2010 A dissolving and needle-free nano-patch that can be mailed out to households during a plague has been developed by Australian researchers. According to Australian Institute for...

Medtronic One Step Closer to Artificial Pancreas
28 July 2010 Diabetes patients could be one step closer to an artificial pancreas after a Medtronic study showed that using an insulin pump with a continuous glucose sensor provided better control over...

Vanderbilt Surgeons Replace Heart Valve Without Open Surgery
28 July 2010 A technique called transcatheter pulmonary valve replacement, which replaces heart valves without open surgery, has been performed for the first time at the Vanderbilt Paediatric Heart Institute. ...

Boston Scientific Warns of Possible Heart Defibrillator Failures
28 July 2010 Boston Scientific has sent an advisory letter to physicians warning that some models of its implantable heart defibrillators have shown a higher rate of magnetic reed switch failure. No...

GE Healthcare Subsidiary to Develop Improved MRI Techniques for Children
28 July 2010 A subsidiary of GE Healthcare is teaming up with clinicians and researchers at Cincinnati Children's Hospital Medical Center and Ohio State University to find better ways to take magnetic...

US University Students Develop Early Labour Detector
27 July 2010 Graduate students at Johns Hopkins University in the US have developed a device that can detect the early signs that indicate a woman is going into labour. The CervoCheck device consists of...

Report Shows Concern Over Cardiac Device Software
27 July 2010 Software defects in life-sustaining medical devices such as pacemakers and infusion pumps could be risking public health, a report by the Software Freedom Law Center (SFLC) has...

Seegene Announces New Sepsis Test
27 July 2010 Seegene has announced the availability of Magicplex Sepsis, a quick screening test which can identify more than 90 leading sepsis-causing pathogens at their earliest stage. Magicplex...

Alcon's Constellation Vision Devices Recalled
27 July 2010 The US Food and Drug Administration has issued a Class I recall for certain devices of Alcon's Constellation Vision System due to software and hardware problems. Alcon sent a letter to...

Implantable Soft Tissue Monitor Receives FDA Clearance
26 July 2010 Kent Medical Device's long-term implantable device for radiographically marking soft tissue sites during and after surgical procedures has been approved in the US. The KMD-Mark1,...

Research Suggests Larger Biopsy Forceps Improve Cancer Diagnosis
26 July 2010 Two independent clinical studies have found that Cook Medical's BIGopsy Backloading Biopsy Forceps' ability to obtain larger tissue samples improves the diagnosis of suspicious ureteral or...

Respiratory Devices Market Will Nearly Double by 2016
26 July 2010 The global respiratory devices market is expected to reach $8.2bn by 2016, almost double the $4.2bn recorded in 2009. According to the GlobalData report, market is expected to grow at...

Study Finds Speech Screening Effective at Diagnosing Autism
26 July 2010 Infoture has developed a device that can screen children for autism based on how they talk, according to researchers in the US. A small recorder, fitted into a child's pocket, analyses what...

Flexible Robotics Could Reduce Trauma in Vascular Surgery
23 July 2010 Using robotics reduces blood vessel trauma during minimally invasive procedures to repair diseased arteries, research has found. According to surgeons from the Methodist DeBakey Heart...

Sanuwave Granted European Patent for Shock Wave Generating Device
23 July 2010 Sanuwave Health has been awarded a European patent for its shock wave generating device, giving the company exclusive rights to use piezoelectric fibres to produce acoustic energy in human...

Artificial Heart Begins Final Pre-Clinical Tests
23 July 2010 Carmat, a medical start-up backed by the European Aeronautic Defence and Space Company, has announced it is in the final stages of pre-clinical tests of its completely artificial heart for...

Scientists Develop Speedy DNA Analysis Technique
23 July 2010 Scientists have developed a new DNA analysis method that cuts the time it takes to melt DNA molecules into a barcode from 24 hours to just two. DNA molecules contains AT and GC...

Congress Urged to Overturn Home Medical Equipment Bidding Bill
22 July 2010 The American Association for Homecare (AAH) has requested that Congress pass HR 3790, a bill to repeal the Medicare competitive bidding programme for durable medical equipment in a budget...

FDA Issues Warning Over Stolen Advair Diskus Inhalers
22 July 2010 The US Food and Drug Administration (FDA) has warned the public against using certain Advair Diskus inhalers, which were stolen from a distribution warehouse in August 2009 and have since...

Vaccine Patch Could Replace Needles
22 July 2010 A vaccine-delivery system that uses 100 tiny, dissolvable needles embedded in a plaster–like patch has been developed by the researchers at the Georgia Institute of Technology. The patch,...

Speedier Antibody-Based HIV Test Developed
22 July 2010 An HIV test that combines an antibody microarray with a lens-free holographic imaging device has been developed to analyse CD4 and CD8 T-cell numbers in blood samples. The test requires only...

HLL Spacer Balloon Could Lessen Cervical Cancer Treatment Pain
21 July 2010 A spacer balloon that could reduce the pain and discomfort cervical cancer patients experience during treatment by lowering the dose of radiation required by 30% has been developed by HLL...

Stentys Completes Apposition II Stent Study Enrolment
21 July 2010 Stentys has finished enrolling patients on a study to compare its Apposition II stent with conventional balloon-expandable stents in patients with acute myocardial infarction. The Apposition...

Global Dental Implants Market to Reach $4.2bn in 2015
21 July 2010 The global dental implants market is expected to rise from $3.2bn in 2010 to $4.2bn in 2015, according to a MarketsandMarkets report. The firm says that the global dental implants market...

UK Hospital Trials TomoTherapy Treatment System
21 July 2010 The James Cook University Hospital in Middlesbrough, UK, has begun treating cancer patients with the TomoTherapy Hi-Art treatment system, which delivers state-of-the-art CT image-guided...

Health Group Commends US Preventative Care Rules
20 July 2010 The Trust for America's Health (TFAH) has praised new rules on preventive care released as part of the Affordable Care Act in the US. The organisation said the rules represent a new era...

UK Researchers Unveil Acoustic Device to Spot Knee Osteoarthritis
20 July 2010 A prototype that can spot the onset of osteoarthritis in the knees is being developed by researchers at the Universities of Lancaster and Central Lancashire. The acoustic device scans the...

European Trauma Fixation Device Market on the Rise
20 July 2010 The trauma fixation devices market could be worth more than $660m in 2010, and will increase in value in the years ahead, according to a report by the Millennium Research Group. The...

BioSTAR Receives Positive Results for Hole-in-Heart Implant
20 July 2010 BioSTAR's biodegradable implant has been found to have comparable closure rates to the Amplatzer Septal Occluder (ASO) in children with an atrial septal defect (ASD). ASD is a heart...

FDA Gets Tough on Baxter Infusion Pump Recall
19 July 2010 The US Food and Drug Administration (FDA) has ordered Baxter Healthcare to provide a transition guide for patients following the April recall of its colleague volumetric infusion pumps...

Covidien Acquires ev3 for $2.6bn
19 July 2010 Ireland-based healthcare product provider Covidien has acquired endovascular surgery device maker ev3 Inc. for $2.6bn. ev3 will become a part of Covidien's Vascular Products line in its...

Havel's Unveils Four New Ultrasound Needles
19 July 2010 Havel's has unveiled a new line of needles with micro laser etching (MLE) near the tip. The new MLE echogenic feature allows users to pass wires or catheters through the cannula...

SonoSite Introduces Enhanced Needle Visualisation
19 July 2010 A needle visualisation system that resolves the "lost needle phenomenon" has been introduced by SonoSite. The company's Enhanced Needle Visualisation improves needle tracking to give...

Quant Leukaemia Test Awarded CE Mark
16 July 2010 Asuragen and Life Technologies Corporation have announced that they have received the CE mark for the BCR/ABL1 Quant Test, which is designed to help clinicians monitor and treat individuals...

DiaTech MiCK Assay Shown to Predict Best Chemo Therapy
16 July 2010 The Microculture Kinetic (MiCK) in-vitro assay for apoptosis can be used to predict the best chemotherapy response for endometrial cancer patients, a study has found. The test uses a panel...

Sernova Records Positive Results for Pre-Clinical Diabetes Device
16 July 2010 Sernova's Cell Pouch System has received positive results in long-term trials for treatment of the pre-clinical model of diabetes. The Cell Pouch System is a medical device that is...

Study Offers Hope to Cancer Patients
16 July 2010 Radiation administered using the Strut-Adjusted Volume Implant (SAVI) can control the rate of cancer and could reduce complications caused by alternative types of brachytherapy, a two-year...

Freshmedx Finds Partners With Key to Mexican Market
15 July 2010 Freshmedx has entered into a joint venture with a Mexican partnership to co-develop, market, sell and distribute its lung cancer diagnostic system in Mexico. The US-based company's...

Johnson & Johnson to Acquire Micrus Endovascular
15 July 2010 Johnson & Johnson has announced it will acquire Micrus Endovascular Corporation in a cash-for-stock exchange of $480m, based on Micrus Endovascular's 20.5 million fully diluted...

Guideline Suggests MRIs Are Best for Stroke Detection
15 July 2010 The American Academy of Neurology has issued new guidelines that say MRIs are more effective at diagnosing strokes than CT scans. The academy said MRI scans detected 83% of strokes, compared...

FDA Urged to Embrace ID System for Medical Devices
15 July 2010 Hospitals, medical societies and group purchasing organisations in the US have urged the US Food and Drug Administration (FDA) to come up with a unique device identification (UDI) system to...

Avid's Brain Dye Gets Positive Results for Alzheimer's Detection
14 July 2010 Brain scans using a radioactive dye developed by Philadelphia-based Avid Radiopharmaceuticals can detect Alzheimer's disease, a study has found. The dye, called florbetapir, is in the final...

Histogenics Corp Trials Knee Surgery Device
14 July 2010 Histogenics Corporation has launched a Phase III study to evaluate the effectiveness of NeoCart, an autologous tissue implant for repairing knee cartilage injuries. The study will evaluate...

Catheter Connections DualCap Cleared in US
14 July 2010 Catheter Connections has received 510(k) approval from the US Food and Drug Administration for its DualCap product. DualCap is the only medical device which has disinfecting caps for both...

Cardiac Concepts Announces First European Tests for RespiCardia
14 July 2010 Cardiac Concepts has enrolled its first European patients on a pilot study to understand the respiratory and cardiac benefits of its RespiCardia System. RespiCardia is an implantable...

Taiwanese Researchers Develop Epilepsy Suppression System
13 July 2010 A team of researchers from the National Cheng Kung University (NCKU) in Taiwan have developed a system that could detect and suppress absence seizures and drug-induced epilepsy. The...

MarginProbe System Shows Positive Results
13 July 2010 Using the MarginProbe System to remove cancerous tissue during breast-conserving surgery reduces the need for further procedures, a European post-market study has found. The research...

Roche MRSA Test Receives FDA Approval
13 July 2010 Roche Molecular Systems has received US Food and Drug Administration (FDA) clearance for its LightCycler MRSA Advanced Test. The qualitative, in-vitro diagnostic test uses real-time...

PEAK Surgical Unveils PlasmaBlade 3.0S
13 July 2010 PEAK Surgical has introduced the PlasmaBlade 3.0S, a dissection device for use in spine surgery procedures. The device precisely cuts and cauterises pathological tissue while reducing...

Bioengineers Develop Non-Contact Heart Sensors
12 July 2010 Researchers at the University of California, San Diego, have devised a new heart sensor that can record ECG and EEG data without touching the skin. According to bioengineers Gert Cauwenberghs...

Boston Scientific Begins MultiSENSE Clinical Trial
12 July 2010 Boston Scientific Corporation has enrolled the first patient in its MultiSENSE clinical trial, which aims to develop a system that issues a clinical alert to physicians if a patient shows signs...

ECRI Expands Universal Medical Device Nomenclature System
12 July 2010 ECRI Institute has announced an expansion of recognised terms for its Universal Medical Device Nomenclature System (UMDNS). UMDNS is a standard international nomenclature and coding system...

RePort Guide Catheter System Approved in Europe
12 July 2010 Reverse Medical Corporation's RePort Guide Catheter System has received the CE Mark. The RePort Guide Catheter System is designed to provide intracranial access during...

Physio-Control Defibrillators Recalled
09 July 2010 The US Food and Drug Administration (FDA) has recalled Physio-Control's LifePak 20 and 20e defibrillators due to a battery problem. Physio-Control, a subsidiary of Medtronic, had already issued...

Birth-Simulating Device Developed to Train Birth Attendants
09 July 2010 Norwegian medical device manufacturer Laerdal Medical has unveiled a new birth-simulating device to help train birth attendants in developing countries. The "MamaNatalie" can be worn like...

FDA Plans Changes to 510(k) Approval Process
09 July 2010 The US Food and Drug Administration (FDA) is planning to make changes to the 510(k) approval process for medical devices, and they could come into effect this year. Jeffrey Shuren, director...

C.R. Bard Acquires SenoRx
09 July 2010 US medical device manufacturer C.R. Bard has completed its acquisition of SenoRx Inc in a deal valued at around $200m. SenoRx is based in Irvine, California, and develops devices to detect...

FDA Approves Implantable Miniature Telescope
08 July 2010 The US Food and Drug Administration (FDA) has approved the Implantable Miniature Telescope (IMT), a tiny device that can restore vision in patients with end-stage age-related macular degeneration....

New Imaging Technique Could Provide Cancer Breakthrough
08 July 2010 Cerenkov luminescence imaging (CLI) could make the development of radiopharmaceuticals to diagnose and treat cancers more efficient, new research has found. The study, published in the Journal...

UK Patient Receives Motion-Sensing Pain Relief Implant
08 July 2010 A pain relief implant that uses motion-sensing technology has been used in the UK for the first time. The device – called a neurostimulator – has a motion sensor that uses the force and...

NHS and QinetiQ Co-Develop Lung Disease Sensor
08 July 2010 A new system for patients with chronic lung disease has been developed by NHS clinicians and QinetiQ engineers. MidTECH measures saliva for proteins whose concentration might indicate...

Neuros Medical Receives US Department of Defense Grant
07 July 2010 Neuros Medical has received a $1.5m award from the US Department of Defense to develop its new neurostimulation therapy, called Nerve Block. Nerve Block uses high-frequency,...

Study Calls for Guideline Revision on Sprint Fidelis Extraction
07 July 2010 A study has revealed that surgery to remove Medtronic's faulty heart defibrillator wire may be safer than originally announced. The Sprint Fidelis defibrillator lead was recalled in 2007...

Breathing System Filters Transmit Bacteria When Wet, Study Warns
07 July 2010 The breathing system filters used in anaesthesia and intensive care units transmit harmful bacteria and yeast when they become wet, new research has revealed. The study, published in the...

NHS Watchdog Recommends Balloon Catheter
07 July 2010 The National Institute for Health and Clinical Excellence (NICE) in the UK is recommending the SeQuent Please balloon catheter for patients with restenosis following insertion of bare...

First Latin-American Patients Receive VMAT Cancer Treatment
06 July 2010 Five cancer patients in Mexico have become the first Latin-Americans to be treated with Elekta's VMAT radiotherapy treatment enhanced with Monaco planning software. The patients at OCA...

Study Predicts Healthy Growth for Saudi Arabian Medical Device Market
06 July 2010 The medical device industry in Saudi Arabia is forecast to grow at a compound annual growth rate of about 12% between 2010 and 2012, according to a RNCOS report. The report - Saudi...

Elekta's Fifth-Gen Gamma Knife Brings New Treatment Options
06 July 2010 Elekta has said that the latest version of its Gamma Knife is "radically changing" the way US physicians are treating brain metastases and other brain disorders. The company reported an...

Europe's Longest Stent-Graft Gets CE Mark
06 July 2010 W. L. Gore & Associates has received CE Mark approval for its 25cm stent-graft, the longest available in Europe. The Gore Viabahn Endoprosthesis with Propaten Bioactive Surface is designed...

Palm-Sized Haemoglobin Testing Device Gets FDA Approval
05 July 2010 Masimo's handheld device for non-invasive haemoglobin spot-check testing has received 510(k) clearance from the US Food and Drug Administration (FDA). The Pronto-7 – the first Masimo device...

Medtronic MRI Pacing System Receives CE Mark
05 July 2010 A pacing system that allows physicians to conduct full body scans in an MRI scanner without positioning restrictions has been given the CE Mark. Medtronic's Ensura MRI SureScan pacing...

Roche and IBM to Develop New DNA Sequencing Technology
05 July 2010 Roche has announced that it is working with IBM to develop a nanopore-based technology, which could lead to cost-effective personalised healthcare. The technology is designed to read and...

Vitrolife Needle Reduces Pain During Egg Collection
05 July 2010 The Swemed Sense follicle aspiration needle causes less pain and bleeding than a conventional needle when used for oocyte aspiration, according to a multicentre study conducted in Sweden. ...

FDA Approves Biomerix Ventral Hernia Repair Mesh
02 July 2010 Biomerix Corporation’s Ventral Hernia Repair Mesh has received 510(k) clearance from the US Food and Drug Administration (FDA). The mesh is used to treat hernias and soft tissue deficiencies,...

LifeScan Unveils New Blood Glucose Monitoring System
02 July 2010 A device that could take the pain out of blood glucose testing has been introduced in the US by LifeScan. The OneTouch Delica Lancing System has been put forward as an aid for people...

Researchers Design New Cochlear Implant to Combat Deafness
02 July 2010 A new cochlear implant designed for children and adults with profound deafness has been developed by a research team from the Medical College of Georgia and Georgia Institute of Technology. ...

NHS Trust Introduces Home Monitoring for Chronically Ill Patients
02 July 2010 NHS Central Lancashire in the UK is piloting a remote patient care management device to help the chronically ill manage their conditions at home. The Intel Health Guide allows patients to...

New Funding Announced for Low-Cost Device Development
01 July 2010 The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has announced supplemental funding for eligible NIBIB-supported research grants to assist collaborative work...

Claros Point-of-Care PSA System Awarded CE Mark
01 July 2010 Claros Diagnostics' point-of-care diagnostic system has received CE Mark approval for use in prostate-specific antigen (PSA) testing in the European Union. The Claros system is a...

Shrink and Lydall to Collaborate on New Diagnostic Platform
01 July 2010 Shrink Nanotechnologies and device manufacturer Lydall will work together to develop single-molecule detection sensors. The two companies have entered into a technology integration...

MSC and Hutchinson Announce Healthcare Training Partnership
01 July 2010 Medical Simulation Corporation (MSC) has partnered with Hutchinson Technology to develop and deliver a simulation to teach US medical staff how to use Hutchinson's InSpectra StO2;...

June 2010

Top

Danish Researchers Develop New Bladder Cancer Test
30 June 2010 Researchers in Denmark have developed a new assay to test for the tumour markers that point to bladder cancer. The Danish Cancer Society and the Herlev University Hospital of Copenhagen teamed...

BSP's ECG Add-On Receives CE Mark Approval
30 June 2010 Biological Signal Processing (BSP) has announced that its HyperQ AD-100 device has received CE Mark approval in Europe. The device uses a proprietary algorithm to analyse electrocardiogram...

GE Healthcare to Invest $15m to Develop PET/CT Scanner
30 June 2010 GE Healthcare has announced plans to invest $15m to design, develop and manufacture a new PET/CT molecular imaging system at its R&D facility in Bangalore, India. GE Healthcare South...

Blood Test Could Predict Menopause
30 June 2010 A blood test that measures ovarian hormone levels can predict when women will reach the menopause, Iranian scientists have said. The test was able to predict the age at which women reached...

St Jude Medical’s Ablation Catheter Wins Japanese Approval
29 June 2010 St Jude Medical's Therapy Cool Path Ablation Catheter has received approval and reimbursement approval from the Japanese Ministry of Health, Labour and Welfare. The device is a thin,...

Medtronic Signs Up First Patient for Insulin Device Study
29 June 2010 Medtronic has enrolled its first patient on the ASPIRE study of its MiniMed Paradigm x54 System, which aims to identify the clinical data needed for US Food and Drug Administration approval. ...

FDA Approves 20-Minute Hep C Test
29 June 2010 The first point-of-care test for detecting hepatitis C antibodies in unmodified blood samples has been approved by the US Food and Drug Administration (FDA). OraSure Technologies'...

Boston Scientific's New Lead Splitters Approved in US
29 June 2010 Two spinal cord stimulation (SCS) lead splitters, developed by Boston Scientific for use with its Precision Plus Spinal Cord Stimulator System, have been approved by the US Food and...

European Researchers Developing Intelligent Medical Sensors
28 June 2010 European researchers are developing intelligent sensors to monitor patients' symptoms and alert doctors if medical intervention is needed as part of the CHIRON project. CHIRON (Cyclic...

FDA Approves EverOn Touch System
28 June 2010 The US Food and Drug Administration (FDA) has approved EarlySense's new system to help hospitals comply with patient-turn protocols. The EverOn Touch System includes an online display that...

Mirasol System Selected for Blood Safety in Poland
28 June 2010 Poland's Ministry of Health has chosen CaridianBCT's Mirasol Pathogen Reduction Technologies System to improve the safety of its fresh frozen plasma supply. The Mirasol system uses...

Neuro Kinetics Receives Grant for Diabetic Retinopathy Device
28 June 2010 Neuro Kinetics (NKI) has received a Phase II small business innovation research (SBIR) grant to develop a new ophthalmic screening device and test protocols to detect and diagnose...

Starkey Introduces "Invisible" Hearing Aid
25 June 2010 An ear-canal hearing aid that is invisible to other people has been launched by Starkey Laboratories. The S Series iQ OtoLens is custom-molded to sit behind the second bend of a patient's ear,...

Riverain's Lung Cancer Detecting System Wins FDA Approval
25 June 2010 An updated version of OnGuard, Riverain's computer-aided lung cancer detection device, has been approved by the US Food and Drug Administration (FDA). OnGuard Chest X-ray Computer-Aided...

EUREF Certifies its First Digital Mammography System
25 June 2010 The Selenia digital mammography system has been given "mammographic type test" certification from the European Reference Organisation (EUREF). Selenia is the first mammography system of any...

Vascular Robot has Potential to Standardise Catheter Navigation
25 June 2010 A vascular robot developed by Hansen Medical could help surgeons reduce vessel trauma during catheter manipulation, trial data suggests. The pre-clinical, in-vivo study also found the robot...

Rheos System Proved Effective for Lowering Blood Pressure
24 June 2010 CVRx's Rheos System is an effective treatment for hypertension in people who cannot control their blood pressure with medication, a study has found. The device lowers blood pressure in...

FDA Clears Jetstream G3 SF Atherectomy System
24 June 2010 The newest version of the Jetstream peripheral revascularisation catheter for treating peripheral vascular disease has received 510(k) clearance from the US Food and Drug Administration...

New Guidelines for Breast-Specific Gamma Imaging Published
24 June 2010 The Society of Nuclear Medicine Procedure Guidelines Committee has issued guidance on using breast-specific gamma cameras to carry out breast scintigraphies. The guidance aims to establish...

First Total Artificial Heart Patients Leave Hospital
24 June 2010 The first three recipients of SynCardia Systems' temporary Total Artificial Heart have been discharged from hospital, after being given the company's Freedom portable driver. The driver weighs...

Robotic Devices Help New York Stroke Survivors
23 June 2010 A New York hospital is pioneering the use of robotic devices in stroke rehabilitation as part of ongoing clinical research trials. The New York-Presbyterian Hospital/Columbia University...

Follow-Up Data Proves Safety of OrbusNeich Stent
23 June 2010 OrbusNeich's Genous Bio-engineered R stent is safe and effective when used with a drug-eluting balloon in the percutaneous treatment of coronary artery stenosis, according to clinical...

Philadelphia Hospital Begins Using Non-Surgical Heart Valve Implants
23 June 2010 The Children’s Hospital of Philadelphia in the US has become the first hospital in its region to implant transcatheter pulmonary heart valves in children with heart defects. The...

FDA Approves Assay to Detect HIV Antigens and Antibodies
23 June 2010 The first test that can simultaneously detect HIV antigens and antibodies has been approved by the US Food and Drug Administration (FDA). Abbott Laboratories's Architect HIV Ag/Ab Combo assay...

First Flexible Tip Ablation Catheter is Given European Approval
22 June 2010 The first flexible-tip ablation catheter has been awarded the CE Mark at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques. St Jude Medical's Therapy Cool Flex...

New Brain Imaging Technology Could Speed Up Research
22 June 2010 Clinical research company Kendle has announced that it is now offering Brain Network Activation (BNA) imaging. BNA imaging technology, developed by Israeli medical technology company...

Asia Pacific Medical Devices Market to Reach $62.3bn by 2012
22 June 2010 The Asia Pacific medical devices market is expected to reach $62.3bn by 2012, according to a forecast by Frost & Sullivan. The consulting firm believes that the market boom will be driven...

Anatomically Designed Catheters Reduce PVI Time by 35%
22 June 2010 Anatomically designed ablation catheters achieve pulmonary vein isolation (PVI) 35% faster than traditional point-by-point focal ablation procedures, a Medtronic study has found. According...

Brainlab Seals Deal for Toshiba CT Scanner
21 June 2010 Brainlab AG has signed an agreement to integrate Toshiba Medical Systems' Aquilion LB Computed Tomography (CT) scanner into its Brainsuite iCT operating room for neurosurgeons. The...

North Shore-LIJ Partners with MSC for Training Tools
21 June 2010 Medical Simulation Corporation (MSC) has entered an agreement to provide New York-based hospital group North Shore-LIJ Health System with training equipment and services. North Shore-LIJ...

St Jude Medical Begins Heart Therapy Trial
21 June 2010 St Jude Medical has enrolled the first patient on its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimise Heart Failure Therapy) study. The randomised, controlled, prospective and...

Kinetic Given FDA Clearance for Wound Management System
21 June 2010 Kinetic Concepts has been given 510(k) clearance from the US Food and Drug Administration (FDA) for its Prevena Incision Management System, a negative-pressure wound therapy product. The...

EU Approves CorMatrix Cardiac Tissue Repair Device
18 June 2010 The CorMatrix ECM for Cardiac Tissue Repair has been awarded the CE Mark. The device can be used to repair heart tissue during open heart surgery without leaving permanent synthetic or...

Medical Device Industry Vacancies to Rise
18 June 2010 Job opportunities in the medical device industry are expected to increase in the second half of 2010 as the world economy recovers. According to a survey carried out by Antal International,...

Solos Endoscopy Unveils New Endscope Lens Adapter
18 June 2010 Solos Endoscopy has developed a relay lens adapter system for its MammoView product line. The system allows the MammoView scope and endocoupler to join with virtually all video systems...

Biomet Moves to Mill-Turn Machines
18 June 2010 Biomet Sports Medicine has announced it is now using multifunction mill-turn machines to reduce setup time, instead of conventional computer numerical control (CNC) turning centres. The move...

Adherus Spinal Sealant Awarded CE Mark
17 June 2010 HyperBranch Medical Technology's Adherus Spinal Sealant has been given the CE Mark. The sealant can be used during spinal surgery that requires a watertight seal to prevent cerebrospinal...

Halt Receives Approval for its Electrosurgical System
17 June 2010 The Halt 2000GI Electrosurgical System for soft tissue ablation using radiofrequency energy has been cleared by the US Food and Drug Administration (FDA). Halt says its system provides an...

Injectable Bone Provides a New Hope for Stem Cell Delivery
17 June 2010 Researchers in the UK have developed a new class of "injectable bone" materials, which could be used in stem cell delivery. The materials, developed at the University of Nottingham, can...

EverOn Patient Monitoring System is a Success, Study Suggests
16 June 2010 A multicentre study conducted at several hospitals in the US and Israel has found that the EverOn patient supervision system can accurately detect a patient's deterioration. The system,...

Greatbatch and St. Jude Sign Feedthrough Deal
16 June 2010 St. Jude Medical has selected Greatbatch Medical as its partner for filtered feedthroughs, which are used in cardiac-rhythm management devices. This will give the company access to...

India Plans Regulatory Checks on Medical Devices
16 June 2010 The Indian government has announced that it plans to conduct regulatory checks on the quality of all medical devices marketed in the country, including diagnostic equipment such as MRI...

AtriClip System Receives FDA Clearance
16 June 2010 The AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system, developed by AtriCure, has received clearance from the US Food and Drug Administration (FDA). The AtriClip system can...

Gore Launches Cloud-Based 3D Case Planning System
15 June 2010 An internet cloud-based 3D advanced visualisation and decision support system has been launched by W. L. Gore & Associates. The GORE 3D modelling system and case planning aid uses...

ASCO Issues Guidelines to Improve Tumour Marker Use
15 June 2010 The American Society of Clinical Oncology (ASCO) has issued a set of guidelines for the use of serum markers in the diagnosis, treatment and management of germ cell tumours (GCTs) in men,...

Device to Assess Peristomal Skin Lesions Launched
15 June 2010 An instrument to track the incidence and prevalence of peristomal skin lesions has been launched by ConvaTec. The evidence-based SACS Instrument assesses and classifies peristomal lesions by...

Cook Medical Submits Zilver PTX Stent for Pre-Market Approval
15 June 2010 The polymer-free Zilver PTX Drug-Eluting Peripheral Stent has been submitted to the US Food and Drug Administration (FDA) for pre-market approval. Zilver PTX, developed by Cook Medical,...

TAXUS Element Stent System Launched in EU
14 June 2010 Boston Scientific has launched its new coronary stent system in the European Union and other CE Mark countries. The TAXUS Element Paclitaxel-Eluting Coronary Stent System integrates...

GE Receives NIH Grant to Develop Nerve Imaging System
14 June 2010 GE Global Research has received a four-year, $4m grant from the National Institutes of Health (NIH) in the US to optimise a new nerve labelling agent and imaging system. The agent, developed by...

Curexo's Next-Generation ROBODOC Supports First Surgery
14 June 2010 Curexo Technology Corporation's next-generation ROBODOC Surgical System has been used in the US for the first time, assisting in a hip replacement operation. Dr William Bargar, the surgeon...

Sysmex America and Premier Enter Three-Year Haematology Agreement
14 June 2010 Sysmex America will provide its services to Premier member-hospitals and healthcare sites after signing a three-year contract with Premier Purchasing Partners. The contract, which will...

VNR Launches MedSmart Pill Dispensing System
11 June 2010 A new automated dispensing and reporting system has been launched by New York-based home care agency Visiting Nurse Regional (VNR) Health Care Services. MedSmart makes sure that patients take...

SGS Develops Medical Device Packaging Test
11 June 2010 SGS Consumer Testing Services has announced that it will offer package integrity testing for medical devices and pharmaceutical products. The new service measures the protection...

Wright Launches Split-Thickness Skin Grafting System
11 June 2010 Wright Medical Group has commercially launched its system for split-thickness skin grafting via a minimised donor site. The XPANSION Micrografting System is a single-use disposable instrument...

US CRM, Electrophysiology and Ablation Markets to Exceed $12bn by 2016
11 June 2010 The cardiac rhythm management (CRM), electrophysiology and ablation device markets in the US are forecast to rise from $8.1bn to more than $12bn by 2016, according to a report. The...