News Archive
Archive of industry news from the global medical industryNews By Date
February 2012
Top
Endologix completes patient enrolment in PEVAR trial
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
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
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
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...
Boston Scientific introduces EUS aspiration needle
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...
Argus II retinal prosthesis system found to treat retinal pigmentosa
Second Sight Medical Products' Argus II retinal prosthesis system has demonstrated improvements in blind people suffering from degenerative diseases, such as retinitis...
DINW introduces extremity MRI scanner in Northwest
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
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
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
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...
Olive Medical unveils cost effective surgical imaging system
US-based medical device company, Olive Medical, has launched the industry's first surgical camera system to enable surgical imaging at a lower...
Boston implants first patient with Promus Element stent
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,...
AngioDynamics to take over Navilyst Medical
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
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
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
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
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
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
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
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...
DiagnoCure announces colorectal cancer assay results
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...
FDA clears Interventional Spine intervertebral body fusion device
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...
Boston IVF develops new saliva test to monitor infertility treatment
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...
Medtronic enrols first patient in Arctic Front cardiac system comparison trial
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...
Alere wins FDA CLIA waiver for rapid flu test
Alere has received a clinical laboratory improvement amendments (CLIA) waiver from the US Food and Drug Administration (FDA) for its influenza A&B...
Covidien EverFlex stent meets safety and efficacy endpoints
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...
Amarantus licenses Power3 Medical NuroPro blood test
US-based Amarantus BioSciences has licensed the NuroPro blood test from Power3 Medical...
Verisante presents positive Aura clinical study data
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
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
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
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
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...
St Jude reports benefits of FFR-guided coronary treatment
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...
Medtronic Endurant stent graft receives European marketing approval
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...
Ventana and Bayer partner to develop diagnostic assay for cancer therapy
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
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
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
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
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...
PLC Systems reports positive results of RenalGuard trial
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
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
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
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
Agilent Technologies and Integrated Diagnostics have formed a strategic partnership to develop protein-based assays that detect major human diseases at an early...
Ventana partners with Pfizer and CST to develop lung cancer diagnostic test
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...
FDA approves Neomend Progel extended applicator spray tip
The US Food and Drug Administration (FDA) has granted premarket approval for Neomend's new Progel extended applicator spray tip, designed specifically for thoracic...
Smith & Nephew wound therapy system gets FDA clearance
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...
Qiagen and MPIIB partner to develop tuberculosis diagnostic assay
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)...
Genous stent shows efficacy in dual antiplatelet therapy patients
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
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...
GI Dynamics introduces EndoBarrier device in the Netherlands
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...
NinePoint Medical VLE imaging system wins FDA nod
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...
Medtronic launches remote glucose monitor in the US
Medtronic has launched its mySentry remote glucose monitor in the US following approval from the Food and Drug Administration...
BioLineRx commences BCM CE mark registration trial
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...
SeptRx enrols patients in InterSEPT trial
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
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...
Critical Diagnostics assay help predict mortality risk in heart patients
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...
Mindframe's Capture LP devices get European approval
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...
December 2011
Top
Australian TGA approves Uptake InterVapor system
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...
Season's Greetings from the editorial team
We will be taking a short break over the holiday season. Our daily news service will return in full on 3...
BD Flu A+B detection system gets FDA nod
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
Reva Medical has commenced patient enrolment in a pilot study designed to investigate its ReZolve bioresorbable sirolimus-eluting coronary...
Devon Medical brain access system wins Chinese approval
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...
Cerevast stroke treatment device gets European marketing approval
Cerevast Therapeutics' Clotbust ER, a sonoLysis headframe system used to treat ischaemic stroke in emergency room settings, has received CE mark...
Verisante skin cancer detection system wins Australian approval
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
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...
AtriCure Synergy ablation system wins FDA nod
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...
FDA clears Presage ST2 assay for cardiovascular disease
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...
Honeywell introduces triage solution for emergency responders
Honeywell has released a new technology solution, Safe Triage Pro, to help emergency responders provide faster and more accurate on-scene support and...
Pathwork reports Tissue of Origin test clinical utility
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
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
AngioScore, a developer of angioplasty catheters, has commenced patient enrolment in its drug-coated AngioSculpt scoring balloon catheter first-in-human (FIH)...
FDA clears Meridian illumigene GBS assay
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...
St Jude Medical implants first patient with Portico transcatheter aortic valve implant
US-based St. Jude Medical has implanted the first patient with its Portico transcatheter aortic valve implant in a European clinical...
Aptus HeliFX system found to fix aortic endografts
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...
New York approves Rosetta Genomics miRview mets^2 test
Rosetta Genomics has received approval from the New York State Department of Health to use miRview mets^2 testing on patient tumour...
Medtronic neurostimulation system found effective in chronic pain treatment
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
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...
DFine wins approval to launch StabiliT system in Canada and Mexico
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
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...
Echo reports positive results of glucose monitoring system
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...
Xeltis to commence tissue-engineered vascular grafts trial
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...
OrbusNeich presents safety profile of Genous stent
OrbusNeich's Genous stent was found to be safe when combined with a ten-day dual antiplatelet therapy (DAPT) in the multicentre...
Sorin Group adult oxygenator wins European approval
Sorin Group, a global medical device company, has received European approval for its Inspire oxygenator system, designed for cardiopulmonary bypass procedures in adult...
Estech enrols patients in staged hybrid ablation study
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...
Apollo signs MoU to test Titan robotic surgical technologies
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...
NSF funds UA researchers' development of new imaging device
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...
Roche cobas EGFR mutation assay gets European approval
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...
Quidel Sofia fluorescent immunoassay wins CE mark
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...
AirXpanders treats first patient in XPAND trial
AirXpanders has treated the first mastectomy patient undergoing breast reconstruction in the AirXpanders patient activated controlled tissue expander system for breast reconstruction (XPAND)...
FDA clears Covidien SpiderFX embolic protection device
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
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
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
Wound Management Technologies has signed a letter of intent to acquire US-based medical device distributor...
Cognizant wins multi-year contract from AstraZeneca
Business process outsourcing services provider Cognizant has signed a multi-year agreement with AstraZeneca to deliver comprehensive biostatistics and medical reporting...
Boston gets FDA clearance for new cardiac devices
Boston Scientific has received US Food and Drug Administration (FDA) approval for its Incepta, Energen, and Punctua cardiac resynchronisation therapy defibrillators (CRT-Ds) and...
Quanterix to develop botulinum toxin assay
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...
Cytori Celution One system gets European approval
Cytori's Celution One system, intended for hospitals as a platform device with life-critical applications across multiple specialties, has been granted the CE...
St Jude CRT-D and pacing lead gets FDA clearance
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
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...
Uptake Medical treats first patient with InterVapor system
Uptake Medical has treated the first patient using its InterVapor system, designed for endoscopic lung volume reduction in patients with severe...
Covidien Endo Stitch suturing device found effective against benign conditions
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...
Sapiens secures funding to develop deep-brain stimulation therapy
Sapiens Steering Brain Stimulation has received a €3.5m (£3m) award from Wellcome Trust to develop next-generation deep-brain stimulation...
UK researchers develop new blood-pressure monitor
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...
Avita Medical acquires intellectual property rights from McComb Foundation
Avita Medical has successfully completed the transfer and acquisition of intellectual property from the Australia-based McComb...
Neuros gets FDA approval begin electrical nerve block technology study
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...
November 2011
Top
Toshiba America Medical Systems introduces Aquilion imaging system
Toshiba America Medical Systems has introduced its new Aquilion Prime CT at the Radiological Society of North America's annual meeting in Chicago,...
FDA clears Philips' whole-body PET/MR imaging system
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
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...
FirstMark PREvent blood assay could diagnose coronary artery disease
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...
US researchers develop new device for urinary problems
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...
New airflow control device found to reduce asthma symptoms
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...
Proteome develops in-vitro assays to treat allergies
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
Multi-speciality healthcare company Allergan has developed a new silicone gel-filled breast implant and introduced it in...
BD MAX MRSA assay gets European approval
BD Diagnostics has received the CE mark for an assay to identify patients infected with...
Biotronik implants first patients with new Lumax 740 ICDs
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
Royal Philips Electronics has introduced its new Philips Veradius Neo mobile C-arm to enhance patient...
Boston's Promus Element Stent gets FDA nod
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
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
Medtronic has received US Food and Drug Administration (FDA) approval for its iPro2, a next-generation continuous glucose monitoring...
3D Systems to acquire Vidar Systems and Z Corporation
3D Systems has signed an agreement to purchase Contex Group subsidiaries Vidar Systems and Z Corporation for...
FSS enrols first patients in FlexStent studies
Flexible Stenting Solutions (FSS) has enrolled the first patients in two trials of its FlexStent, a femoropopliteal stent and delivery...
Genesis to produce Future Path urine-management bag
Genesis Plastics Welding has announced that it will manufacture Future Path Medical's iBag urine-management...
Aptus EndoStapling system gets FDA nod
Aptus Endosystems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its HeliFX aortic securement...
FDA clears Abbott Chagas disease test
The US Food and Drug Administration has approved a test developed by Abbott Laboratories to detect antibodies to Trypanosoma cruzi, the cause of Chagas...
Covidien to acquire Barrx Medical
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
SuperNova Diagnostics has entered into a commercial partnership with European specialist healthcare distributor Concile to develop the point-of-care diagnostic test for assessing...
Deep brain stimulation therapy show promise in depression treatment
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...
Cervilenz device receives CE mark
Cervilenz Inc has received the CE mark for its CerviLenz device, designed to measure vaginal cervical...
BSD cancer treatment system gets FDA approval
The US Food and Drug Administration (FDA) has granted humanitarian device exemption marketing approval to BSD Medical's BSD-2000 hyperthermia...
FDA clears Medtronic pain management system
The US Food & Drug Administration (FDA) has approved Medtronic's AdaptiveStim with RestoreSensor neurostimulation system for the management of chronic...
Sanuwave dermaPACE found effective against diabetic foot ulcers
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
CerMed International has received CE mark approval for its CerMap cervical specimen collection...
AtriCure completes patient enrollment in DEEP AF trial
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...
CorMatrix gets FDA approval to begin CorMatrix ECM trial
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...
Spiracur begins SNaP wound care system study
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...
Boston implants first patient with left atrial appendage closure device in Colombia
Boston Scientific's Watchman left atrial appendage closure device has been implanted in the first group of patients at Angiografia de Occidente in Cali,...
FDA clears PositiveID diabetes management system
PositiveID has received US Food and Drug Administration (FDA) clearance for its iglucose mobile health system for diabetes...
X-spine spinal implant system gets FDA approval
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
Landauer, a provider of personal and environmental radiation monitoring services, has acquired all outstanding equity interests of US-based IZI Medical Products for around...
DFine commences StabiliT vertebral augmentation system trial
DFine, a developer of minimally invasive radiofrequency targeted therapies, has begun a prospective and randomised study to investigate the clinical effectiveness of minimally invasive...
CardioDx gene-expression performs well in trial
CardioDx's Corus CAD blood-based gene expression test has demonstrated superior performance in a...
Torax continence restoration system wins CE mark
Torax Medical has received the CE mark for its Fenix continence restoration...
MDxHealth prostate cancer assay shows efficacy
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...
Abbott Absorb drug-eluting scaffold found to restore blood flow
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...
Telecare solutions maker wins UKTI competition
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
Hansen Medical's Magellan Robotic System has been used for the first time at St Mary's Hospital for the treatment of peripheral vascular...
Boston PolarCath dilatation system found to reduce restenosis rate
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...
Elixir initiates DESolve bioresorbable coronary system study
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...
BioVentrix completes enrolment in heart failure treatment system trial
BioVentrix has completed patient enrolment in a pilot human clinical trial of its PliCath HF heart failure treatment...
Biotronik Pantera Lux paclitaxel-releasing balloon meets endpoint
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...
St Jude reports positive transcatheter heart valve results
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...
Abbott new hepatitis assay gets CE mark
Abbott's Architect hepatitis B surface antigen (HBsAg) diagnostic test has been awarded the CE...
FDA clears Idev transhepatic biliary stent system
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Idev Technologies' 6 French (6Fr) Supera Veritas transhepatic biliary stent...
Westhouse Medical acquires Battlebridge cancer screening patents
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
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...
Verisante skin cancer detection system wins CE mark
Verisante Technology has received the Conformite Europeenne (CE) mark for its Verisante Aura, used to diagnose skin...
New Electronic Nose could detect tuberculosis
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...
Svelte treats first patient in DIRECT study
Svelte Medical Systems has treated its first patient at Auckland City Hospital in Auckland, New Zealand, in the DIRECT...
FDA clears Femasys low-pressure hysterosalpingography device
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...
Micell reports positive DESSOLVE I study data
Micell Technologies has announced the preliminary data from the DESSOLVE I study of the MiStent Sirolimus drug-eluting coronary stent...
Carotid Wallstent found to provide safe carotid artery stenting
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...
Maquet Cardiovascular acquires Atrium Medical
Maquet Cardiovascular has secured US Federal Trade Commission approval to acquire Atrium Medical, a developer of medical device technologies for interventional cardiology and radiology,...
Medtronic direct aortic therapy system gets CE mark
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
Sunshine Heart has presented the results of a US Food and Drug Administration-approved feasibility study of the C-Pulse heart assist...
NIH funds Kensey Nash for tendon product research
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...
K2M develops two new spinal fusion treatment systems
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
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...
Terason introduces new portable ultrasound system
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...
Johnson & Johnson company acquires SterilMed
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...
TriVascular abdominal stent graft gets FDA approval
The US Food and Drug Administration (FDA) has approved TriVasculars' Ovation abdominal stent graft system to treat abdominal aortic...
Solta Medical weight reduction system receives Health Canada clearance
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
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
Asuragen's microRNA-based test, miRInform Pancreas, has demonstrated improvements in the diagnosis of pancreatic ductal...
SpyGlass system demonstrates effectiveness in bile duct disease diagnosis
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
Medtronic has implanted the first patient with its CoreValve system in a clinical trial in...
Quanterix PSA assay proven effective
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
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...
SMSI secures funding to develop glucose-monitoring system
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
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...
Quest to introduce new influenza test in Europe
Quest Diagnostics is to introduce the new Simplexa Flu A/B & RSV Direct test in...
Brainsway gets FDA approval to begin bipolar disorder trial
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...
Everist Genomics acquires Angiologix
Everist Genomics has acquired Angiologix, the developer of the AngioDefender diagnostic device for assessing endothelial...
FDA clears new Gen-Probe HPV assay
The US Food and Drug Administration (FDA) has approved Gen-Probe's Aptima human papillomavirus (HPV) assay, used to diagnose cervical...
Medtronic's Assurant stent gets FDA nod
Medtronic has received US Food and Drug Administration (FDA) clearance for its Assurant cobalt iliac balloon-expandable stent system, designed to treat narrowed iliac...
Spine Wave initiates NuCore injectable nucleus device study
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...
Sensei and Ideal Life partner for wireless health devices
Sensei has partnered with Ideal Life to integrate Ideal Life's wireless heath devices into the Sensei Connect...
Medtronic gets FDA approval to begin diabetes device study
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...
EarlySense to introduce new patient monitoring system at MEDICA 2011
EarlySense will unveil a new contact-free patient monitoring system at MEDICA 2011 in Düsseldorf, Germany, which will be held on 16-20...
FDA approves two Spinal USA spinal fusion products
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...
Apnex sleep apnoea treatment system wins European approval
Apnex Medical has gained CE Mark approval for its hypoglossal nerve stimulation system, used to treat patients with obstructive sleep...
Spineology develops new pedicular fixation system
Spinal implants and instruments maker Spineology has developed a new, minimally invasive pedicular fixation...
Stellar partners with Life Diagnostics to develop ELISA test kits
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...
FDA approves Stealth Therapeutics implantable arm port
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...
October 2011
Top
Medtronic enrolls first patient for Symplicity HTN-3 clinical trial
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...
Tryton Medical completes patient enrollment for Tryton IDE Study
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
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...
FDA clears Quidel analyser and influenza assay
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...
Microline Surgical acquires Starion Instruments
US-based Microline Surgical has acquired Starion Instruments, a developer of surgical technology to seal and divide soft...
OrbusNeich Genous stent proven effective in study
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
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...
Interface Biologics signs licensing agreement with Navilyst
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
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
CryoLife has enrolled the first patient in a US investigational device exemption trial for its BioFoam surgical matrix, designed for cellular aggregation and enhanced...
Medicis Technologies LipoSonix system gets FDA clearance
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...
FDA clears Abbott AML diagnostic test
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...
Sonitus unveils new hearing device
Sonitus Medical unveiled its SoundBite hearing system, a non-surgical and removable hearing prosthetic to treat single-sided deafness and conductive hearing...
NeuroSigma to fund ADHD nerve stimulation trial
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...
PSA test could predict low-risk prostate cancer, says study
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...
OncoSec submits device master file to FDA
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...
Bolton completes enrolment in abdominal stent-graft trial
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...
Sorin Group enrolls first patient in ISIS-ICD clinical trial
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...
FDA clears Canon TX-20 tonometer
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
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...
BioMimetic's Augment bone graft gains Australian aaproval
Australia's Therapeutic Goods Administration has approved BioMimetic Therapeutics' Augment bone graft for marketing and listing on the Australian Register of Therapeutic...
Hansen Medical begins study of robotic catheter system
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
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
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...
InfraReDx LipiScan imaging system could detect LCPs associated with heart stroke
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...
Spineology interbody fusion system wins FDA nod
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
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...
First German patient completes treatment with Sapheon closure system
Sapheon has treated its first patient with bilateral saphenous reflux in Germany using its Sapheon closure...
FDA clears Medtronic Aquamantys system for hemostatic sealing
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...
St. Jude Medical renal denervation technology to treat hypertension
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...
OrSense hemoglobin monitor to detect hemorrhage in less time
OrSense's non-invasive hemoglobin (Hb) measurement system, NBM 200MP, was found to monitor blood loss continuously and detect hemorrhages within...
Ventus Medical sleep apnea therapy shows positive results
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...
Paramit signs agreement to buy Lemtronics
Medical device and instrument manufacturing services provider Paramit has entered into an agreement with Lemarne to purchase its Malaysian-based manufacturing organisation,...
FDA approves PLC Systems to begin RenalGuard trial
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...
Biodesix VeriStrat test could identify RCC disease characteristics
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,...
EMKinetics commences neuromodulation system trial
EMKinetics has begun the TranStim transdermal neuromodulation system trial in patients suffering from urge incontinence and overactive...
Echo Therapeutics commences Symphony tCGM system trial
Echo Therapeutics has initiated a clinical study of its Symphony transdermal continuous glucose monitoring (tCGM) system in patients with Type 1 and Type 2...
PCF joins Exosome for biofluid molecular diagnostics technology clinical validation
The Prostate Cancer Foundation (PCF) and Exosome Diagnostics have entered into a multiyear collaboration agreement to accelerate clinical validation of Exosome's biofluid molecular...
Isto Technologies' bone graft substitute and extender wins CE mark
Isto Technologies, an orthobiologics company, has received the Conformite Europeenne (CE) mark approval for its InQu bone graft substitute and...
FDA approves Unisense FertiliTech EmbryoScope
Unisense FertiliTech's EmbryoScope has received Food and Drug Administration (FDA) clearance for clinical use in...
Sanuwave's dermaPACE technology shows positive results
Sanuwave Health's dermaPACE extracorporeal shockwave technology has demonstrated superiority over hyperbaric oxygen therapy in increasing angiogenic and tissue regenerative molecular changes...
FDA clears CorMatrix carotid tissue repair implant
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...
BSD hyperthermia system found to benefit cancer patients
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
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...
EMA grants orphan drug status to OctreoPharm's SOMscan
The European Medicines Agency (EMA) has granted orphan drug status to OctreoPharm Sciences' SOMscan, used for the diagnosis of gastro-entero-pancreatic neuroendocrine...
Chembio syphilis assay obtains CE mark
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...
Cappella coronary sidebranch stent shows positive data
Cappella Medical Devices has announced the initial long term follow up data for its Sideguard coronary sidebranch stent from Manchester Royal Infirmary in the...
Innocoll surgical adhesion barrier wins European approval
Innocoll has secured European approval for its CollaGUARD surgical adhesion barrier for the prevention of postoperative adhesions following abdominal and pelvic...
Bovie Medical to develop electrosurgical safety device
Bovie Medical, a manufacturer and marketer of electrosurgical products, is set to develop a laparoscopic electrosurgical electrical leakage detection...
Cardiac treats first patient in Titan II study
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...
Japan approves Masimo pulse co-oximeter
Masimo has received Japanese Ministry of Health Labor and Welfare regulatory clearance for its Rad-87 pulse co-oximeter with rainbow acoustic monitoring...
Presbia Flexivue Microlens gets Israel registration approval
Ophthalmic-device company Presbia has received medical device registration approval in Israel for its Flexivue Microlens solution for treating...
Japan approves Vitrolife IVF treatment tools
Vitrolife has secured Japanese regulatory approval for its aspiration needles and micro pipettes, which are used in IVF...
MagForce treats glioblastoma with NanoTherm therapy
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
NuVasive, a minimally disruptive surgical products maker, has acquired Impulse Monitoring, a US-based intra-operative monitoring...
Medtronic reports positive ablation system trial results
Medtronic has reported positive data from a trial of its Phased RF Ablation System for persistent atrial...
Novus reports pre-clinical data of TIGR surgical mesh
Novus Scientific has reported the three-year pre-clinical data of the adsorbable TIGR matrix surgical mesh versus a permanent mesh in a sheep...
St Jude Medical Penta surgical lead wins Japanese regulatory approval
Japanese Ministry of Health, Labor and Welfare has approved St Jude Medicals' Penta surgical lead, designed for neurostimulation therapy to treat chronic...
GE Healthcare 3T wide-bore MR system gets FDA clearance
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...
Kerecis completes first human trial of lipid collagen matrix
Kerecis, a manufacturer of tissue-regeneration materials, has completed the first human clinical trial of its MariGen Lipid Collagen...
Bioness completes foot drop study enrolment phase
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...
Positive trial results for Brainsway deep TMS system
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...
Carticept's Navigator DS gets FDA clearance
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...
FDA approves Ventana H. pylori antibody
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...
FDA, European commission clears Bioness wireless hand paralysis device
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
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...
Brainsway TMS device wins Israeli Ministry of Health approval
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
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)...
GI Dynamics EndoBarrier found effective against diabetes, obesity
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...
Vermillion PAD blood test shows positive results
Vermillion, a molecular diagnostics company, has reported positive results from the intended use study for its peripheral artery disease (PAD) blood test,...
Siemens new mobile digital X-ray system wins FDA approval
The US Food and Drug Administration (FDA) has approved Siemens Healthcare's Mobilett Mira, a mobile digital X-ray system with a wireless...
Expanding Orthopedics initiates XPED system post-market study
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...
JenaValve transapical TAVI system receives CE mark approval
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
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...
Getinge to buy Atrium Medical
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...
FDA clears Nucletron new VCMC applicator for gynecologic cancers
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...
Boston Scientific enrols first patient in NECTAR-HF trial
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
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
Roche has received US Food and Drug Administration (FDA) clearance for its Accu-Chek Aviva Plus test...
Cardiac Dimensions wins CE mark approval for mitral contour system
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...
FDA clears KCHC pediatric face mask
Kimberly-Clark Health Care (KCHC) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its pediatric face...
Calypso receives IDE approval for lung cancer study
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
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...
Johnson & Johnson unit to acquire SterilMed
Endo-Surgery, a Johnson & Johnson company, has signed a definitive agreement to acquire the US-based medical device repair company...
September 2011
Top
Medtronic commences Engager system trial
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...
Aton acquires OrthoScan
German private investment company Aton has acquired OrthoScan, an innovator in the orthopaedic imaging market that specialises in mini C-arm...
FDA clears Titan Spine fixation device
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...
Boston bronchial thermoplasty system shows long-term efficacy results
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...
Given Imaging PillCam shows sensitivity against colorectal lesions
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...
Aesculap acquires Aragon Surgical
German-based surgical instruments and sterilisation container systems maker Aesculap has acquired the assets of Aragon...
FDA clears Zynex electrotherapy device
Electrotherapy medical device maker Zynex has received US Food and Drug Administration (FDA) clearance for its NexWave...
Avinger Ocelot catheter receives CE mark
Avinger has received the CE mark for its Ocelot catheter, designed to treat peripheral artery...
Pulmonx pulmonary assessment system effectively treats emphysema
Pulmonx has announced the final results of its Chartis multi-centre study confirming that the use of the Chartis pulmonary assessment system effectively treats...
Mela Sciences MelaFind PMA receives FDA approvable letter
The US Food and Drug Administration (FDA) has issued an approvable letter to Mela Sciences for the MelaFind pre-market approval (PMA)...
OncoSec ElectroChemotherapy shows efficacy against cancer
OncoSec Medical has presented positive results a Phase IV head and neck cancer trial, which has demonstrated that OMS ElectroChemotherapy is safe and...
Uptake Medical's InterVapor system gets CE mark
Uptake Medical has received the CE mark for its InterVapor system, an endoscopic lung volume reduction system to treat severe...
IRIS prognostic cancer test secures FDA 510(k) clearance
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
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
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
AirXpanders has reported the positive results of Patient Activated Controlled Expansion (PACE) feasibility study investigating the AeroForm breast tissue expansion...
Quidel human metapneumovirus assay receives CE mark
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...
FDA clears Toshiba M-Power interface
Toshiba America Medical Systems' M-Power interface has received US Food and Drug Administration (FDA)...
Stentys completes patient enrolment in APPOSITION III study
Stentys has enrolled 500-patients in the APPOSITION III study for its self-apposing stent, used to treat acute myocardial...
Gynesonics commences study for the VizAblate system
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...
CardioKinetix secures financing to develop ventricular partitioning device
CardioKinetix has raised $44m in Series E financing to progress the development of the Parachute ventricular partitioning...
FSS begins patient treatment with FlexStent system
Flexible Stenting Solutions (FSS) has treated the first two patients in a clinical trial using the FlexStent Femoro popliteal self-expanding...
Anulex fiXate Tissue Band gets FDA clearance
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...
Biotronik completes patient enrolment in BIOLUX P-I study
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...
Arbor Vita HPV biomarker test shows promise
Arbor Vita's has announced positive interim clinical study results for its diagnostic human papillomavirus (HPV) E6 test for cervical cancer and precancerous...
Nanosphere blood culture test demonstrates efficacy against bacterial targets
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...
Varian Medical to acquire Calypso Medical Technologies
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...
Covidien reports positive results of stapling system
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...
Roche cobas HPV test shows promise in cervical cancer screening
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...
Researchers develop new fluorescence-guided technology to detect tumours
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...
New test for sleeping sickness
Geneva-based not-for-profit foundation FIND and Japanese diagnostics company Eiken have developed a next-generation molecular test for sleeping...
Ivantis reports positive Hydrus implant study results
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...
GI Dynamics' EndoBarrier shown to improve glycaemic control rate
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...
DMC to begin sleep apnoea trial
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...
Medtronic spinal system wins second FDA clearance
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...
PediGuard shows efficacy in spine surgery
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...
AxoGen reports Avance Nerve Graft study results
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. ...
Zimmer spinal fixation system gets paediatric clearance
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
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
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...
Baxano enrols first patient in STRiDE trial
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...
FDA clears two Circa Scientific devices
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...
Propel shows efficacy against chronic sinusitis
Intersect ENT's prospective, randomised, controlled, double-blind, multicentre Advance II trial demonstrated that the Propel mometasone furoate implant improves outcomes for patients...
Solta to acquire Medicis Technologies
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...
Cytta deploys CyttaConnect medical monitoring system
Cytta has completed the first patient implantation of its remote medical monitoring system, CyttaConnect. CyttaConnect delivers verifiable, real-time medical data transmission from...
FDA clears IsoRay radiation therapy system
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...
Delcath presents oncology device trial results
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
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...
Crescendo secures financing to develop diagnostic test
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
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
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
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...
Concentric Medical concludes patient enrolment in Trevo trial
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...
Fluke Biomedical's ProSim simulators get FDA nod
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...
Jan Medical enrols first patient in cerebral vasospasm study
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...
Vasomedical acquires Fast Growth Enterprises and Biox Instruments
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...
Croma partners with Ruck Tmed to develop ophthalmic surgical systems
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...
St Jude neurostimulation device wins CE mark approval
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...
Nexera to submit amended antimicrobial claims for respiratory device
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...
Neoprobe receives guidance for RIGScan
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...
Hemosphere HeRO graft wins CE mark approval
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...
US and Chinese universities partner to develop colorectal cancer diagnostics
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...
CardioFocus reports HeartLight endoscopic ablation system trial results
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...
ResQCPR system shown to improve long-term brain function
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...
U-Systems installs somo*v ABUS system in Canada
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
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
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
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
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...
ConvaTec acquires Boston Medical Device
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
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...
Medrad purchases Pathway Medical
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...
Orthocon to develop Bezwada technology
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...
Brainsway reports positive results from magnetic stimulation study
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. ...
Medtronic purchases Peak Surgical and Salient Surgical
Medtronic has acquired Peak Surgical and Salient Surgical Technologies to broaden its portfolio of surgical products. Salient's Aquamantys System uses patented Transcollation technology,...
Stryker to acquire Concentric Medical
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...
LaserGen raises funds to develop sequencing system
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
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...
EMD Millipore acquires Amnis
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...
Implantable oxygen generator developed to fight tumours
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...
Biotronik reports home monitoring system study results
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...
Mauna Kea endomicroscopy system wins FDA approval
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...
Unilife develops new range of auto-injectors
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...
Metabolon completes series D financing
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...
Apollo reports first use of OverStitch system for colonic polyp resection
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...
Qiagen acquires Cellestis
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
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...
CoreValve system found effective for heart surgery
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...
August 2011
Top
Medtronic reaffirms information security commitment
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
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
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
Biotronik has reported the results of its Home Monitoring in Cardiac Resynchronisation Therapy clinical study. The international, multicentre, non-randomised and prospective study was...
FDA clears IQuum influenza A/B assay
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...
ITM treats first patient in rhenium-PTA catheter trial
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
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
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...
Aptiv Solutions acquires Medical Device Consultants
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...
Gen-Probe's Panther system receives Health Canada approval
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
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. ...
NHGRI funds DNA sequencing technology development
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...
Delcath reports top-line results of chemosaturation system
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...
Abbott ophthalmic viscosurgical device wins CE mark approval
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
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...
Vention Medical buys Ansamed
Vention Medical has acquired Ireland's Ansamed, a provider of advanced medical tubing solutions, including catheter design, development and manufacturing services. The acquisition will...
Medrad to acquire Pathway Medical Technologies
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
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
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
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...
Medtronic CoreValve system receives CE mark
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
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. ...
PositiveID completes Phase II glucose-sensing microchip testing
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...
Devicor acquires Neoprobe gamma detection devices
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...
BD acquires Carmel Pharma
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...
OrbusNeich presents Genous stent study results
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...
U-Systems ultrasound device receives Health Canada approval
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...
Seattle Institute receives grant for newborn respiratory device
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
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
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
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
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
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...
Seegene Presents Seeplex DV Assay Trial Results
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...
Prometheus and Medco Partner to Evaluate Thiopurine Metabolite Testing
Prometheus Laboratories and the Medco Research Institute have announced that they will evaluate the use of Prometheus' thiopurine metabolite testing to optimise dosing of...
ArthroCare Knotless Fixation Device Wins FDA Clearance
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...
Crosstrees Pod Delivery Technology Awarded US Patent
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
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...
New Urine Test to Help Diagnose Prostate Cancer
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...
FDA Clears IntriCon Cardiac Monitoring Device
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. ...
Ibis Biosciences Develops New Vector-Borne Pathogen Test
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
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
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 mother's...
MindFrame Reports Capture LP Device's First Implantation in Germany
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...
Abbott Receives FDA Clearance for Herculink Elite Renal Stent System
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...
US Researchers Develop Biomarker Blood Test for Prostate Cancer
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...
Medtronic Reports First Use of Symplicity Catheter System
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. ...
SHS Acquires Spiegelberg Shares
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. ...
CEMD and Leica Microsystems Collaborate to Develop FISH Kits
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...
SI-Bone Initiates Second Phase Study for iFuse Implant System
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. ...
Researchers Develop New Hormone Test to Predict Menopause
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...
US FDA Clears Toshiba 3T MR Imaging System
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...
Ascendx Completes Mixed Financing for VCF Repair System
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...
FDA Approves New GE Healthcare Imaging System
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...
Masimo Lifts Voluntary Recall on Pronto-7 Device
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...
RapidArc Radiotherapy Effectively Treats Blood Cancer: Study
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
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
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
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
Merge Healthcare has completed the acquisition of Ophthalmic Imaging Systems (OIS). The acquisition will add OIS ophthalmic imaging and informatics solutions, including a single...
Vessix Vascular Completes Series B Financing
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...
Siemens Biograph mMR Receives Canadian Approval
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....
Covidien Commences Patient Enrolment in Anti-Restenosis Study
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...
Apnex Given Clearance for Obstructive Sleep Apnoea System Study
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...
Trimega Labs Shortlisted for Orange Innovation Award
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...
IMDx C. Difficile Assay Awarded CE Mark
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...
Becton Dickinson and Lab21 Partner to Develop Aspergillus Assay
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...
Symmetry to Acquire Olsen Medical
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,...
US Researchers Develop New High-Speed 3D Imaging System
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....
MindFrame LP Devices Win CE Mark
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...
Tornier Announces First Implant of Shoulder Joint Replacement System
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...
Intuity Medical Secures Financing For Glucose Monitoring System
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...
Pathwork Tissue of Origin Test Detects Metastatic Cancers
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...
PathoGenetiX Completes Financing for Pathogen Identification System
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....
CareFusion Acquires Rowa
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. ...
FDA Approves Medtronic Advisa MRI System Trial
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
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
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...
Mirador Pressure-Measurement Device Platform Receives CE Mark
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...
Prosthetic Knee System Offered to US Patients
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,...
Histogenics Reports NeoCart Implant Study Results
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...
VeraLight Scout DS Device Receives CE Mark
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...
Roche xCELLigence System to Quantify Cell Proliferation
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...
HIV Combo Test Proven Effective
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...
Vicor Signs Agreement with Zoll Medical
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...
Rheonix Device Could Diagnose Septicaemia
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
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
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...
July 2011
Top
Ontario Officials Award Grant to Cancer Research Institute
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,...
ArthroCare Suture System Receives FDA Clearance
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...
Micell Completes Patient Enrolment in Coronary Stent Study
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
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...
Lutonix Enrols First Patient in Levant 2 Study
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
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...
Penumbra Initiates Stroke Trial
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...
Bio-Rad HIV Assay Receives US Pre-Market Application Approval
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. ...
Christie Radiotherapy Centre Installs Novalis System to Treat Cancer
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...
Medtronic Drug-Eluting Stent Proven Effective in Clinical Trial
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...
Roche to Provide Early Infant Diagnosis HIV/AIDS Tests
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...
EndoBarrier Gastrointestinal Liner Receives Australian Approval
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...
Breath Analyser Could Diagnose Breast Cancer at 'Stage 0'
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...
Roche Colorectal Cancer Diagnostic Test Receives CE Mark
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...
Canadian Heritage Fund Awards Grant for Cancer Research
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...
New Trial for Throat Cancer Test
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. ...
Malvern and Paraytec to Develop Imaging Technology
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....
Cutera Laser System Receives Canadian Approval
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...
National Institutes of Health Awards Grant to Mbio for Flu Test
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...
Artegraft Bovine Carotid Artery Effective for Haemodialysis Access
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. ...
ImaCor's ClariTEE Probe and Zura System Receive CE Mark
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...
nanoMR Completes Financing for Pathogen Capture System
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...
Sorin Group Acquires Estech Cannulae Portfolio
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
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
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...
IHD-Amy Blood Test Could Diagnose Alzheimer's
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...
Alphatec Receives Japanese Approval for Illico System
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
Bacterin International has acquired the assets of US-based medical device distribution company Robinson MedSurg for $1m. Bacterin acquired approximately $500,000 in inventory,...
St Jude's Ilumien System Receives CE Mark
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...
BioTime Receives Grant to Develop HyStem Microcarriers
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
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
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...
US Regulator to Unveil Medical Device ID Rule
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...
Non-Invasive Breath Test Could Diagnose H1N1 Strain
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...
ActiViews CT-Guide System Approved in US
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,...
Biosense Enrols First Patient in SMART-AF Trial
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...
US Researchers Begin CoreValve Device Study
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
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...
Vapotherm's Heliox Device Receives Canadian Approval
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...
Biotronik Begins Bioflow-II Study
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
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
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
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
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...
US Approves St Jude Deep Brain Stimulation Study Expansion
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...
IlluminOss Bone Stabilisation System Used to Treat Osteoporotic Fracture
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 Study Demonstrates Pathwork Tissue of Origin Test Efficacy
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...
Calmare Pain Therapy Device Receives Korean Approval
Competitive Technologies has received Korea Food and Drug Administration approval for its non-invasive Calmare pain therapy device. Calmare is indicated to treat patients...
Qiagen to Acquire Stake in Ipsogen
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 Buy Peak Surgical
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...
Japan Approves Cardiac Science's Powerheart G3 Automated External Defibrillator
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...
US Researchers Develop High-Resolution Imaging Technology
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...
ThromboView Found to be Well-Tolerated by Patients
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...
New Assay to Detect Lung Cancer
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
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....
Medtronic to Acquire Salient Surgical Technologies
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,...
Radiofrequency Augmentation Therapy Treats Vertebral Compression Fractures
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...
Laser Raman Spectroscopy System Detects Lung Cancer
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...
Endosense and GE Healthcare Sign Joint Development Agreement
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...
Zebrafish Embryo Could Detect Medical Device Toxicity
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...
Prototype Device Could Help Doctors Prescribe Appropriate Medication
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...
US Researchers Say PACE Technology is Effective for Ischaemia
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. ...
Researchers Develop Robotic Endoscopy Surgery to Treat Gastric Tumours
Researchers at Nanyang Technological University and National University Hospital in Singapore have developed a new technology to treat gastric tumours. The master and slave...
CareFusion to Acquire Rowa
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...
Merck Receives European Approval for Pre-Filled Pen Injectors
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
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. ...
MedMira to Develop Rapid Hepatitis B Test
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...
Pocket Ultrasound Could Reduce Costs and Improve Care
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...
US Scientists Develop Personal Dosimeter to Measure Radiation Exposure
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...
Sonitus SoundBite Hearing System Receives Additional FDA Clearance
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...
Ansell Acquires Sandel Medical Industries
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. ...
Auxogyn Initiates Clinical Study of Embryo Assessment System
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...
US Surgeon Implants Pacemaker-Like Device for Bowel Incontinence
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...
US Medical Facility Conducts Study of New Technology for Insomnia
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
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. ...
Aegea to Develop Endometrial Ablation System
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...
Canadian Researchers Develop Drug Delivery Device
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...
NEC Medical Diagnostic Monitor Receives FDA Clearance
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
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...
CardioFocus Endoscopic Ablation System Proven Effective for Atrial Fibrillation
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...
Left Ventricular Assist Device Therapy Proven Effective in Older Patients
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...
Radiofrequency Ablation Therapy Could Treat Spinal Tumours
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
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...
New Hybrid Procedure to Treat Atrial Fibrillation
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...
June 2011
Top
US University Develops New Software for Brain Scan Research
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
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
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. ...
Biotronic Completes Patient Enrolment in 4EVER Clinical Study
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,...
Space Research Could Lead to New Cancer Treatment
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
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...
ATI Reports Positive Study Results of Neurostimulation System
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
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...
Saliva Test Can Predict Age
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...
Researchers Say Proton Beam Therapy Can Control Breast Cancer
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...
Non-Invasive Breath Test Could Detect Vitamin B12 Deficiency
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...
GE Healthcare Mobile X-Ray Systems Receive FDA Clearance
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...
Dentsply to Acquire Astra Tech for $1.8bn
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...
Australia and New Zealand to Form Joint Medical Devices Regulatory Body
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
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...
MiMedx Receives FDA Clearance for HydroFix Ortho Shield
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...
Philips Acquires AllParts Medical
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...
Japanese Researchers Develop Remote-Control Endoscope
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...
Researchers Reveal Spinal Proteins That Could Predict Alzheimer's
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...
BSD Presents Results of Microwave Ablation System
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
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
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
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
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. ...
Optical Microchip Technology Detects Foot and Mouth Disease
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...
Myoguide Injection Site Targeting System Receives CE Mark
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
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. ...
London Surgeon Develops New Spinal Fixator
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...
Foetal ECG Detects Acidosis
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...
Cerbomed Vagus Nerve Stimulation Device Shows Promise for Epilepsy
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...
Medtronic Thoracic Stent Graft System Successful in Trial
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...
Non-Invasive Brain Implant Could Treat Paralysis
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...
Salient Receives FDA Clearance for Aquamantys Bipolar Sealer
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...
Continence Control Device Shows Efficacy in Colostomy Patients
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...
Neogenix and Cambridge Biomedical to Develop ELISA Assay
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...
UK MoD Subsidiary Files Lawsuit Against 3M Over MRSA Test
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...
DePuy Ceramic-on-Metal Hip Replacement Receives FDA Approval
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...
Tissue of Origin Test Given Medicare Coverage
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...
Scientists Develop Cooling Cap to Treat Insomnia
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...
Non-Invasive Liver Tests Could Predict Survival in Hepatitis C Patients
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...
Hamilton and Isee3D to Develop Microscope Technology
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...
Trial of Health Monitoring Device for Heart Disease Continues
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...
Scientists Develop Portable System to Diagnose Cancer
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...
Saliva Test Developed for Scoliosis Diagnosis
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...
Siemens Biograph mMR Receives FDA Clearance
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 Closed-Loop Artificial Pancreas Developed
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...
US Researchers Develop Pulseless Heart
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 Computational Tool to Detect Cancer-Causing Genes
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...
Leishmaniasis Assay Receives FDA Clearance
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
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...
New Imaging Method Developed for Cardiovascular Disease Diagnosis
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...
Extracorporeal Shockwave Therapy Effective for Osteoarthritis Damage
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
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
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
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
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. ...
BioMimetic Completes Patient Enrolment for Augment Rotator Cuff Graft Trial
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. ...
UK Hospital Performs Pioneering Asthma Treatment
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...
Magnetic Fields Found to Reduce Blood Viscosity
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...
Arteriocyte and US Army to Develop Cellular Therapies for Orthopaedic Trauma
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...
European E. Coli Crisis Prompts Increase in Screening Plate Production
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...
NICE Approves Eye Implant for Macular Oedema
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...
Idaho Technology Receives FDA Clearance for Q Fever Test
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...
Provista Develops New Blood Test to Detect Breast Cancer
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
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...
Microsphere Radiation Therapy Effective Against Liver Metastases
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...
Everist Test Found to Predict Colorectal Cancer Recurrence Risk
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...
Scientists Develop Digital Stethoscope to Aid Heart Disease Diagnosis
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...
Covidien Receives FDA and CE Mark Approval for Hernia Mesh
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...
Saliva Test Used to Detect Cytomegalovirus Infections in Newborns
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...
Roche and Clovis to Develop EGFR Mutation Test
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
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. ...
New Onyx Glue to Treat Aneurysms
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...
UK Researchers Developing Electronic Nose to Detect Necrotising Enterocolitis
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
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...
ConforMIS Completes First Surgeries Using iTotal CR Knee Resurfacing System
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
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
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
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
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. ...
New Test to Diagnose Hereditary Leiomyomatosis and Renal Cell Cancer
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...
Indian Institutions to Develop Diabetes Test Kit
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...
Spectroscopy Device Could Provide Non-Invasive Bladder Dysfunction Diagnosis
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...
New Test Predicts Risk of Mitochondrial DNA Disorder Transmission
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...
Augurex Blood Test for Rheumatoid Arthritis Shows Promise
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...
Emit Corporation Blood and Fluid Warmer Receives US Approval
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...
Boston Scientific Recalls iCross Coronary Imaging Catheter
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
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...
May 2011
Top
Quest Announces ImmunoCAP Study Results
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...
New Blood Test to Detect MRSA Infections
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
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 RealTime Molecular Test Receives CE Mark
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...
Novamed Develops Home Test to Detect Heart Attacks
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...
Blood Test to Diagnose Depression Unveiled
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 Breath Test to Diagnose Chronic Pancreatitis
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,...
Abbott Xience Nano Stent Receives FDA Approval
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...
FDA Approves Patient Enrolment for ORBIT II Trial
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...
Study Says Vectra DA Blood Test Effective for Rheumatoid Arthritis
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...
New Heart Monitoring Device Detects Arrhythmia
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. ...
PET Scans Could Predict Effectiveness of Drug-Resistant Tuberculosis Treatments
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. ...
New Nanoscale Imaging Technology Could Aid Multiple Sclerosis Diagnosis
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...
NADiA ProsVue Test Identifies Prostrate Cancer Recurrence
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
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...
Aptus EndoStapling System Receives CE Mark
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...
Boston Stent System Proven Effective for Small Vessel Coronary Disease
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...
CT Scan Could Predict Early Death in Diabetic Patients
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...
Holmium Laser Therapy Effective as Benign Prostatic Hyperplasia Treatment
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...
Neonatal Heart Defect Test Could Become Compulsory
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...
Biotronik Metal Scaffold Device Shows Positive Results
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...
Abbott HCV Test Receives FDA Approval
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...
GTx Announces Positive Results from Ostarine Trial
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. ...
Pioneers in Implant Technology and Medical Research Receive European Inventor Award
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...
EnteroMedics Reports First Maestro Rechargeable System Implantation
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...
Maquet Receives CE Mark for Cardioroot Aortic Graft
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...
Medtronic CoreValve System Demonstrates Quality of Life Improvements
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...
Oraya Completes Enrolment for Radiotherapy System Study
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,...
US Infusion Therapy Device Market to Exceed $6.6bn by 2017
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...
Avinger Reports Positive Results for Wildcat CTO Crossing Study
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...
FDA Grants Expedited Review Status for Cancer Device
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...
CryoLife Acquires Cardiogenesis Corporation
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...
Masimo SpHb Monitoring Accurately Measures Haemoglobin and Haemorrhage
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...
Study Says Calypso System Delivers Accurate Radiation
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...
Canadian Province Approves Colorectal Cancer Test Use
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...
New Hereditary Breast Cancer Test Can Cut Costs
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...
NeuroStar TMS Therapy Effective Against Major Depressive Disorder
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
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...
MDxHealth Methylation Test Could Reveal Missed Prostate Cancers
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
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...
Given Imaging's PillCam Able to Detect Colorectal Polyps
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...
Scientists Reveal New Method to Map Myelin Sheath Deterioration
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...
iCAD Receives Chinese Regulatory Approval for SecondLook Digital
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
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. ...
NovaVision Unveils Benefits of Vision Restoration Therapy
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...
CyberKnife Sites Performs SBRT to Treat Prostrate Cancer
Accuray has announced that 85% of European CyberKnife centres are implementing prostate Stereotactic Body Radiation Therapy (SBRT) to treat localised prostate cancer. The CyberKnife...
New Non-Invasive Test Detects Pancreatic Cancer
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...
AspirinWorks Test Determines Effect of Aspirin on Platelets
Corgenix Medical has developed the AspirinWorks Test to determine the effect of aspirin on platelets. AspirinWorks, available through Diagnostic Laboratory Medicine, is the only...
Cellular-Level Visualisation with Cellvizio Effective for Detecting Bilio-Pancreatic Cancer
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...
US Scientists Develop New Imaging Method
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...
Luminex Gastrointestinal Pathogen Panel Receives CE Mark
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...
ImThera Completes Clinical Study of aura6000
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...
Bravo Wireless pH Monitoring System Manages GERD
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...
ArtVentive Endoluminal Occlusion Device Shows Promise in Animal Studies
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...
Covidien Completes Patient Enrolment for Hernia Mesh Study
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...
Septin9 Blood Test Detects Colorectal Cancer
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...
BD Introduces BD MAX Open System in Europe
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,...
Boston Scientific Reports First Cardiac Defibrillator Implantation
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
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...
PENTAX and Hitachi Join Forces to Develop Endoscopic Ultrasound Systems
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...
Caldera Desara Mini Receives CE Mark
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...
Microvolt T-Wave Alternans Detects Sudden Cardiac Arrest
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...
SwabCap Found to Reduce Bloodstream Infection Risk
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
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...
EBR Reports First WiCS Implantation
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...
FDA Clears Sectra Cancer Detector
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
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
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...
NIH Funds Chagas Test Clinical Trial
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...
Electrical Stimulation Therapy Proven Effective for Retinitis Pigmentosa
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
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...
Femasys Receives FDA Clearance for FemVue Saline-Air Device
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...
Idaho Technology Receives FDA Approval for Respiratory Panel
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...
Sorin Introduces Endoscopic Vessel Harvesting System
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,...
Medtronic Completes First Patient Procedure for Diagnostic Catheter
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
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...
Defibtech Recalls DDU-100 Series AEDs
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...
Dune MarginProbe System Enables Cancer Detection
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...
D Medical Subsidiary Receives FDA Approval to Market its Insulin Pump
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...
Mammography Found to Detect Smaller Breast Tumours Than Clinical Exams
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...
April 2011
Top
EnteroMedics Expects to Implant Obesity Device in US by Year End
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...
SpinalMotion Begins Patient Enrolment for Kineflex Cervical Disc Trial
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...
Amerinet and Teleflex Sign Agreement for Peripherally Inserted Central Catheters
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
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...
MedPro Establishes Ultrasound Transducer Repair Facility in US
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
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...
Dehaier to Develop Oxygen Therapy Products in China
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...
Blood-Activated Sensor Could Detect Pancreatitis
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
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...
Gore Excluder Endoprosthesis Procedure Conducted in Australia
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...
New Pelvic-Repair Device Facilitates Minimal Surgery
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
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...
New Test Could Reduce Prostate Cancer Screening False Positives
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...
Breath Test Could Detect Cancer
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...
ICD Patients Experience Complications, Study Shows
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...
Eye Specialists Discover Chronic Diseases First
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...
New Screening Method to Help Diagnose Lipid Storage Disorders in Children
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...
Carmell Raises Funds to Develop Blood-Plasma Devices
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...
Bone Suppression Device Can Improve Lung Cancer Detection, Study Finds
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...
Medtronic and US Hospital Begin Patient Enrolment for Heart Valve Trial
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
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...
New Test to Identify Cancer Patients Who Could Benefit From Diabetes Drug
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...
CSA Group Acquires Devices Testing Firm
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...
FDA Approves Device to Treat Glioblastoma Multiforme
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...
Researchers to Evaluate Urine Tests for Prostate Cancer Diagnosis
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
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
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...
Artificial Pancreas May Improve Diabetes Control in Adults
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...
Pico-Tesla Device Reduces Fibromyalgia Symptoms in Study
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,...
UK Scientists Develop Needle-Free Medicine Test for Premature Babies
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
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
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...
Researchers Discover Biomarkers to Predict Multiple Sclerosis Progression
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
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...
Wrist Circumference May Predict Cardiovascular Risk
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
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...
Cerapedics Reports Positive Results from Bone Graft Study
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...
Positive Results from PositiveID Glucose Device Study
PositiveID has reported that its Easy Check breath glucose detection device has delivered encouraging results in preliminary laboratory testing. The results were within acceptable...
US Researchers Develop Prediction Model for Kidney Disease
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. ...
Enigma Begins Trials of Influenza Detection Assay
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...
Thoughts Used to Move Computer Cursor
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...
Researchers Develop Heart Attack Warning Device
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...
FDA Clears First Test to Diagnose Dengue
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...
New Smartphone Application Could Diagnose Malaria
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...
Myconostica Aspergillosis Test Shows Positive Results in Study
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
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...
Deep Brain Stimulation Could Treat Tremors
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,...
Spectranetics to Initiate In-Stent Restenosis Device Trial
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....
Neuros Pain-Reduction Technology Tests Well
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...
Boston Scientific Initiates Peripheral Vascular Lesions Stent Trial
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...
ICDs Linked to Longer Survival in Cardiac Patients
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...
UK Researchers Develop Stroke Rehabilitation Devices
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 —...
New Device Developed to Treat Resistant Hypertension
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
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. ...
New Test Could Detect Asbestos-Related Cancer
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...
Researchers Identify Genes to Predict Alzheimer's Risk
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. ...
Positive Results from Boston Scientific Coronary Stent Trial
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...
Ventus Reports Positive Results from Sleep Apnoea Device Study
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. ...
Breast Milk Could be Used to Assess Breast Cancer Risk
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...
New Test Could Identify Lung Cancer in Non-Smokers
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...
Edwards Reports Positive Results from Aortic Valve Study
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...
Abbott Reports Positive Results from Vascular Scaffold Study
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
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...
Cardiac Biomarker Could Predict Heart Failure Risk
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...
Non-Tumour Tissue Analysis May Help to Diagnose Prostate Cancer
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,...
Malaysian Researchers Develop Sick Leave Verification Device
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...
New Staging to Improve Prediction of Lung Cancer Recurrence
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...
NeuroLogica CT Scanner Receives FDA Approval
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. ...
Scientia Microcatheter Receives CE Mark
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...
CT Scans for Testicular Cancer Linked to Secondary Malignancies
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...
PhotoMedex Reports Positive Results from Psoriasis Device Study
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...
US Researchers Develop Non-Invasive Blood-Glucose Detector
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...
March 2011
Top
Navy Device Could Diagnose Stroke Trauma Quickly
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...
Biotronik Completes Patient Enrolment in Cardiac System Trial
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...
GI Dynamics Reports Positive Results from Obesity Device Study
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. ...
New Device Could Capture Cancer Cells
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...
Pathway Begins Patient Enrolment in Peripheral Arterial Disease Study
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...
Medtronic Receives FDA Approval for New Defibrillators
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
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...
Chembio Develops Assays for Rapid Disease Diagnosis
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...
Spinal Neuromodulation Device Could Reduce Back Pain
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
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. ...
US Researchers Identify New Colon Cancer Marker
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
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...
Brain Stimulation Could Improve Swallowing Ability in Stroke Patients
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...
Magnetic Therapy May Not Improve Tinnitus
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...
FDA Approves Medtronic CRT-P Systems
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...
Verathon Medical Unveils GlideScope Direct Intubation Trainer
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...
Coronary Calcium Test Could Lower Heart Disease Risk
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...
Sensitive New Test Effective for Identifying Heart Attacks
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...
New Method Developed to Detect Epileptic Seizures
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...
Cardiac Pacemaker Could Prevent Epileptic Falls
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...
Freshmedx Reports Positive Results from Lung Cancer Test Study
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...
NeoTract Initiates Patient Enrolment in Prostate Device Study
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...
Neurotez Develops Test to Predict Alzheimer’s Risk
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...
New Nanomodified Surfaces Could Seal Leg Implants
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. ...
New HPV Test Proven Effective for Cervical Cancer Detection
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...
Global Cardiac Pacemakers Market to Reach $5.1bn by 2015
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)...
Positive Results from Covidien Inguinal Hernia Mesh Study
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. ...
Orthodontic Retainers May Harbour Harmful Microbes, Study Warns
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...
Genomic Breast Cancer Test Shows Positive Results
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...
CSI Receives FDA Approval for Peripheral Arterial Disease Device
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
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
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...
Hydro-Stomach CT Unreliable For Detecting Gastric Cancer
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...
Light Therapy May Improve Cognitive Function in Brain Injury Patients
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...
FDA Approves Bayer MRI Contrast Agent
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. ...
Computer Software Could Help Diagnose Skin Infections
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...
Photodynamic Device Developed to Treat Precancerous Cervical Lesions
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
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
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
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. ...
Elana Receives FDA Clearance for Anastomosis Device
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
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...
HPV Home Tests Could Improve Cervical Screening Rates, Study Suggests
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...
Corindus Begins Coronary Device Study
Corindus Vascular Robotics has initiated a clinical trial of its CorPath 200 System, which offers interventional cardiologists complete percutaneous coronary intervention procedure control from...
Low-Radiation Scan Proven Effective in Ruling Out Heart Problems
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. ...
Neuronetrix Develops Device to Identify Alzheimer's
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...
Japanese Quake Could Disrupt Medical Device Sales
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,...
Sonitus Receives CE Mark for Hearing Aid
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
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
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...
American Medical Reports Positive Prolapse Repair Study Results
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...
Competitive Technologies Enrols Patients in Pain Device Study
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...
Avinger Completes Patient Enrolment in Catheter Trial
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,...
New Technology Could Non-Invasively Monitor Glucose Levels
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
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
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...
US Researchers Develop Device to Capture Cancer Cells
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
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...
DNA Repair Test Could Predict Recurring Bowel Cancer
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...
MabCure Ovarian Cancer Test Effective, Study Reveals
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...
MHRA Issues Warning Over Teleflex Tracheostomy Set
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...
MEMS Sensor Could Detect Early-Stage Atherosclerosis
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. ...
Toenail Test Could Predict Lung Cancer Risk
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...
Breathe Technologies Receives FDA Approval for Ventilator
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...
NASA Technology Used to Reduce Chemotherapy Side Effects
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...
Researchers Develop Non-Invasive Down Syndrome Test
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...
Brain Scans used to Diagnose Alzheimer's in UK Trial
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...
Multifunctional Catheter Could Simplify Heart Surgery
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....
US Researchers Develop Breast Cancer Detection Device
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...
Miracor Completes Coronary Artery Device Study
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...
UK Scientists Announce Breakthrough in Early Bowel Cancer Detection
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...
SuperSonic Reports Positive Results from Ultrasound Study
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. ...
Calypte Reports Positive Results from HIV Test Studies
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...
Ventus Receives CE Mark for Sleep Apnoea Device
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...
TOF PET Scans Improve Cancer Detection
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...
New CPR System Improves Survival Rates
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...
Health Diagnostic Laboratory and Gamma Therapeutics Develop Heart Attack Risk Test
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...
Global Cardiac Rhythm Management Devices Market to Hit $22.3bn
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...
Heart Device Studies Exclude Women, Research Reveals
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
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
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...
Pathwork Reports Positive Results from Study to Determine Cancer Origin
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...
Valeritas Insulin Device Receives FDA Approval for Use with NovoLog
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...
UK Scientists Develop Prostate Cancer Test
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
Biotronik has initiated patient enrolment in a trial to investigate the use of intraoperative defibrillation testing during implantable cardioverter defibrillator (ICD) implantation. ...
Medtronic Reports Positive Results from Heart Valve Study
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...
MeadWestvaco Launches Preservative Free Pharmaceutical Spray Pump
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...
Epigenomics and Qiagen to Develop Colorectal Cancer Blood Test
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
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
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
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
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
FDA Permits Marketing of First Preliminary Norovirus Test
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. ...
Laser-Based Tool Developed to Diagnose Skin Cancer
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...
HbA1c Test Not Effective for Diabetes Diagnosis in Children
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. ...
Researchers Develop Blood Test for Bladder Cancer
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...
Annual Mammograms Help Detect Second Breast Cancers Early
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...
Biomoda Completes Patient Enrolment for Lung Cancer Test
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...
New Test Could Predict Infant Autism Risk
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...
European Minimally Invasive Spinal Implant Market to Exceed €90m by 2017
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
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
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
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
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...
New Device Looks Under Skin to Detect Cancer
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...
Researchers Develop Specific Tuberculosis Test
Researchers have developed a diagnostic tool that allows the sensitive and highly specific identification of patients with active tuberculosis. To develop the assay, researchers...
Fresenius Receives FDA Approval for Home Dialysis Machine
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 Can Accurately Measure Aortic Blood Pressure
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...
Study Shows Long-Term Benefit of Total Knee Replacement
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...
Integra and Stout Medical to Develop Expandable Interbody Device
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. ...
Micell Initiates Patient Enrolment in Coronary Stent Study
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...
Intrinsic Begins Patient Enrolment in Anular Closure Device Study
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...
FDA Approves Expanded Use of Allergan Lap-Band System
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...
Ultrasound Fusion Imaging Helps Tumour Biopsy
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...
Medtronic Reports Positive Results from Spinal Device Study
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
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. ...
Yale University Researchers Develop Turner Syndrome Test
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
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...
Endosense Completes Patient Enrolment in Catheter Trial
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
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...
FDA Reclassifies Medical Device Data Systems
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
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
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
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...
BioSurface Initiates Bone Graft Substitute Study
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. ...
UT Southwestern Scientists Develop Alzheimer's Test
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...
FDA 510(k) Process Linked to High-Risk Device Recalls
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...
U-Systems Completes Automated Breast Ultrasound Study
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...
Researchers Develop Non-Invasive Melanoma Test
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
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
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...
Aperion Initiates Knee Reconstruction Device Trial
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...
Concentric Initiates Patient Enrolment for Clot Retrieval Device
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...
MRI Helpful in Deciding Therapy for Stroke Patients, Study Suggests
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. ...
Cytomedix Receives CE Mark for Blood-Separating Systems
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...
Researchers Develop Device to Simplify Cardiac Surgery
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...
FDA Unveils Medical Device Innovation Initiative
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...
Handheld Sensor Could Detect Impending Asthma Attacks
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...
Wireless Device Could Reduce Heart Failure Hospitalisations
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...
US Interventional Ophthalmic Device Market to Reach $2bn by 2017
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
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...
Researchers Develop Device to Limit Chemotherapy Side Effects
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
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...
Gene Test Could Predict Prostate Cancer Aggressiveness
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,...
BD to Acquire Accuri Cytometers
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
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
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...
FDA Orders TMJ Implant Manufacturers to Conduct Post-Market Surveillance
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...
Optical Device Could Let Diabetics Measure Blood-Sugar With Eye Scans
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...
FDA Approves First Mobile Radiology Application
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,...
Mayo Researchers Develop Device to Measure Brain Serotonin Levels
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
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...
Cepheid and FIND to Collaborate HIV Viral Load Test
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...
Scientists to Develop Non-Invasive Acetone Test for Diabetes
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...
Global X-Ray Systems Market to Reach $4.8bn by 2016
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...
ConforMIS Receives FDA Clearance for Knee Replacement System
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...
UK Scientists Develop Blood Test for vCJD
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
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
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...
Researchers Develop Seizure-Detecting Device
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...
Cyberonics Receives FDA Approval for Vagus Nerve Stimulation Device
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...
Repeat MRIs for Breast Cancer Leads to Fewer False Positives
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...
New Laser Technology Could Lead to Pain-Free Cancer Biopsies
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...
US Researchers Develop Tumour-Tracking Technique
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...
3D X-Rays in Orthodontic Diagnosis Increase Radiation Exposure
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...
New Optical Device Could Help in Tumour Resection
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
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. ...
Cappella Begins Coronary Artery Stent Study
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...
Sorin Receives CE Mark for Aortic Heart Valve
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...
Medical Device Recall Rates Similar in US and Europe
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...
Artificial Pancreas Could Help Pregnant Diabetics
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
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
New Filtration System Could Help to Capture Cancer Cells
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...
US Sues Boston Scientific Over Defective Heart Devices
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...
PDAs Help Doctors to Understand Fibromyalgia Pain
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...
Sonitus Receives FDA Clearance for Hearing Aid
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...
Boston Scientific Begins Patient Enrolment in Coronary Stent Study
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
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. ...
IVAX Receives FDA Approval for Autoimmune Disease Test
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...
Researchers Develop Paper Strips for Rapid Medical Diagnosis
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...
New Instrument Provides Force Feedback in Keyhole Surgery
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. ...
Taiwanese University Develops Prototype Cancer Treatment System
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...
Inappropriate ICD Shocks Increase Mortality Risk
Implantable cardioverter-defibrillators (ICDs) designed to stop dangerous heart rhythms can produce inappropriate shocks, thereby increasing the risk death, researchers from Leiden...
Deep Brain Stimulation Could Decrease High Blood Pressure
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....
Biomerix Receives CE Mark for Soft Tissue Repair Mesh
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
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
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...
US Universities to Conduct Study on Heart Device Implantation
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...
Researchers Develop Infant Ear Correction Device
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....
Study Finds CT Scanning Improves Abdominal Pain Diagnosis
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...
Everist Reports Results of Colorectal Cancer Recurrence Test Study
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...
On-X Life Aortic Valve Receives FDA Approval
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. ...
FDA to Improve 510(k) Approval Process
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. ...
MHRA Issues Warning Over Oxford Weigh Scales
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...
Genetic Test and fMRI May Predict Cognitive Decline
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...
Boston Scientific to Acquire Atritech
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...
Researchers Develop Imaging Procedure to Diagnose Alzheimer's
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...
PositiveID Develops Temperature Sensing Microchip
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
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...
Drug-Coated Stents Help Treat Blocked Leg Arteries
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...
Stents Shown to be Effective in Opening Blocked Brain Arteries
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
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,...
AdvanDx Receives FDA Clearance for Bloodstream Infection Test
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...
US Orthopaedic Extremity Device Market to Reach $4.6bn by 2015
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...
Thermometer Could Reduce Diabetic Foot Ulcers
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...
Ultrasound Helps to Treat Pulmonary Embolisms, Study Finds
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...
First Endovascular Pulmonary Embolism Device Approved
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...
Cook Peripheral Stent Shows Sustained Primary Patency in Study
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. ...
US Marshals Seize Dental Products from Rite-Dent
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...
Nanosphere Receives FDA Clearance for Respiratory Virus Test
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...
Henry Ford Health System Launches Study to Develop Pancreatic Cancer Test
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...
Blood-Sugar Meters Found to be Inaccurate When Used During Pregnancy
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,...
Researchers Develop Neonatal Test for Tyrosinaemia Type I
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
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...
Zoll Completes Cardiac Life-Support Pump Trial
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
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...
Endosense Begins Patient Enrolment for Atrial Fibrillation Catheter Trial
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. ...
OrbusNeich Stent Demonstrates Good Clinical Outcomes
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
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...
PakSense Launches Temperature Monitoring Device
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...
Nfocus Vessel Occlusion System Receives FDA 510(k) Clearance
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
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...
Takeda and Zinfandel to Develop Test to Identify Alzheimer's Risk
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
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...
Scientists to Develop Device to Prevent Radiotherapy Errors
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. ...
Global Endoscopy Devices Market to Exceed $6.5bn by 2016
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...
OPKO and Bristol-Myers to Develop Alzheimer's Blood Test
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...
Boston Scientific Completes Iliac Stent Trial Patient Enrolment
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...
FDA Approves Automated Cardiovascular Test
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...
Hologic Acquires Interlace Medical
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
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...
US Researchers Develop Lab-on-a-Chip Blood Test
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...
UK MHRA Issues Unomedical Feeding Tube Warning
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...
STI Capital Acquires Cardionetics
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...
Haemoglobin A1c Test Can Identify Pre-Diabetes
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. ...
Gynesonics Receives CE Mark for Uterine Fibroids Device
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...
New Device Could Identify Pre-Cancerous Oesophagus Cells
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...
New Test Could Predict Efficiency of Hepatitis C Infection Treatments
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...
Global Market for ECG Telemetry Devices to Reach $1.1bn by 2015
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...
Pico-Tesla Initiates Alzheimer's Device Trial
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...
ReSound Develops Technology to Improve Hearing Aid Performance
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
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...
US Researchers Develop Glaucoma Detector
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...
Boston Scientific Acquires Sadra Medical
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...
BD Diagnostics Submits First Automated HSV Tests to US FDA
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...
Imaging Procedures Often Expose Children to Radiation
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...
Viewing Medical Images on Portable Media Unreliable, Says Study
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...
Most Patients with ICDs Fail to Meet Criteria for Use
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...
CPAP Reduces Sleep Apnoea Fatigue, Says Study
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...
Researchers Develop Test to Predict Lung Transplant Rejection
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
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...
PET Scans Could Evaluate Cognitive Dysfunction in Childhood Epilepsy
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
FlexStent Biliary Self-Expanding Stent Receives FDA 510(k) Clearance
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...
UK Hospital to Trial Retinal Implant
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...
MRI and Cerebrospinal Fluid Testing May Predict Alzheimer's Risk
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...
Abbott Recalls Blood Glucose Test Strips in US and Puerto Rico
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...
Season's Greetings
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...
Medtronic Abdominal Aortic Aneurysm Stent Graft Receives FDA Approval
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
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...
Biomet Completes Patient Enrolment for Tennis Elbow Treatment Study
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...
Arrow Initiates Worldwide Recall of Series 5800 Intra-Aortic Balloon Catheters
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...
Advanced MRI Could be Used to Detect Prostate Cancer Progression
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...
Aethlon Reports Hemopurifier Study Success
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. ...
Brain Imaging Could Predict Reading Improvement in Dyslexics
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...
Tryton Trials Side Branch Stent System
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...
Cystatin C Test Can Predict Kidney Disease Complications
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 Warns of Risks Associated with Shiley Tracheostomy Tubes
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...
St Jude Medical to Take Defibrillator Cables off the Market
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...
Medtronic Receives Approval for Atrial Fibrillation Device
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...
Miracor Receives CE Mark for Coronary Revascularisation System
Miracor Medical Systems has received the European Communauté Européenne (CE) Mark for the Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) impulse system. The system...
Gentag Develops Wireless Diagnostic Test
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...
New Genetic Markers Could Improve Accuracy of Prostate Cancer
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...
MHRA Issues Warning over Surgical Instrument Problems
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...
Researchers Develop Carbon Nanotube to Probe Cells
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...
European Commission to Develop Abdominal Aortic Aneurysm Devices
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...
SINTEF Scientists Develop Sensor Belt to Monitor Patients
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...
Accuray Receives FDA Clearance for Lung Cancer Treatment Component
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...
Swedish Scientists Use PET Scans to Track Alzheimer's
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...
On-X Life Reports Positive Results for Prosthetic Heart Valve
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
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
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...
OraSure Initiates Patient Enrolment for HIV Test Study
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...
UCSF to Test Hair Loss Treatment Devices in Cancer Patients
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...
Australian Scientists Develop Pain Management Implant
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...
Ultrasound Shows Promise in Endometrial Cancer Detection
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...
Medtronic's Subclavian Aortic Valve System Approved
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...
FDA to Review Mercury Use in Dental Fillings
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...
UK Scientists to Develop Rapid STI Test
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
Synergetics USA has entered into a product development and consulting agreement with Retinal Solutions to develop products for retinal surgery. The collaboration will combine...
Chinese Scientists Develop Prenatal Genetic Disease Blood Test
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...
Researchers Develop Biosensor to Identify Dengue Virus
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
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...
Change in Inhaler Design Could Improve Drug Delivery
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...
WHO Endorses Rapid Tuberculosis Test
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...
NeuroWave Receives FDA Clearance for EEG Device
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
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...
Scientists Identify Mechanism of Catheter-Related Bacterial Infection
Scientists from the US National Institutes of Health have identified the mechanism through which catheter-related bacterial infections develop into a life-threatening condition. ...
Abiomed Ends Cardiac Assist Device Study
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
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...
PET/CT Scans Could Predict Local Recurrence of Lung Cancer
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. ...
FDA Advisory Committee Recommends Expanded Use of Gastric Banding System
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...
Researchers Develop Implantable Artificial Kidney
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...
New Bio-Coating Could Improve Implant Performance
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...
UK Researchers Develop Endoscope to Detect Inflammatory Bowel Disease
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...
Conmed's Tissue Fusion Device Receives FDA Approval
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...
bioLytical Receives FDA Approval for HIV Test
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...
St Jude Medical Reports Neurostimulation Device Study Success
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...
Rcadia Reports Positive Study Results of Coronary CT Analyser System
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...
AtriCure Initiates Atrial Fibrillation Trial
AtriCure has initiated patient enrolment for a feasibility trial evaluating a dual epicardial / endocardial procedure for the treatment of patients with atrial fibrillation. The...
CT Scans Show Significantly Low Cancer Risk
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 Radiation-Free Breast Cancer Screening Device
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...
Medical Device Registries Could Improve Patient Outcomes
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 Biologically Based Test for Autism
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...
US Patients Prefer Home Medical Devices, Survey Finds
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...
US Researchers Develop Device to Treat Swallowing Problems
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. ...
ConvaTec's Continence Device Demonstrates Safety and Efficacy
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...
Magnetic Resonance Spectroscopy Could Help to Diagnose Brain Trauma
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...
Researchers Develop Plug-In Interface for Microfluidic Chips
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
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...
US Interventional Cardiology Market to Reach $5bn by 2017
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...
Blood Test Could Predict Cognitive Decline in Parkinson's Patients
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...
Toshiba Announces Trials for Non-Contrast Renal MR Angiography System
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
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...
Micell Initiates Patient Enrolment for Coronary Stent Study
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...
UK Scientists Use Laser to Unblock Clogged Arteries
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,...
November 2010
Top
Study Recommended MRI Screening for Women with Personal History of Breast Cancer
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...
Global Dental Implants Market to Reach $4.2bn in 2015
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,...
Autonomy Corporation Diagnosis Tool Wins Technology Award
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...
Rapid Microscopy Technique Can Identify Cancer Cells
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,...
True Whole-Body Field View PET/CT Better at Staging Cancer
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...
Catheter Ablation Can Reduce Atrial Fibrillation Symptoms
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
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
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. ...
Implanted Heart Devices Pass Real-World Test
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...
Urine Protein Test Can Predict Pre-Eclampsia
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. ...
Ultrasound Could Help to Evaluate Focal Breast Abnormalities
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
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...
Three Boston Scientific Defibrillators Receive CE Mark
Boston Scientific has received CE Mark approval for three of its cardiac resynchronisation therapy defibrillators and implantable cardioverter defibrillators. The PUNCTUA, ENERGEN and...
Spinal Implant Allows Paraplegics to Exercise
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...
Medtronic to Acquire Ardian for $800m
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...
Researchers Develop Device to Strengthen Swallowing Muscles in Parkinson's Patients
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...
Study Recommends Shockwaves to Treat Small Kidney Stones
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. ...
Taiwanese Blood-Glucose Devices Market to Reach $86m by 2016
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...
Carestream Health Receives FDA Approval for Mammography System
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...
Medtronic Reports Positive Results of Cardiac Monitor Study
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...
Researchers Develop Mobile-Phone Based Blood Pressure Monitor
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...
Retailer Fined for Selling Non-Compliant Medical Devices in UK
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...
Ardian Hypertension Catheter Succeeds in Trial
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...
Covidien Reports Positive Catheter Study Results
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...
U-Systems Initiates Study of Breast Ultrasound System
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
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...
US Researchers Develop Genetic Test for Deafness
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...
Researchers Develop Neurostimulation System to Treat Stroke
Researchers at Israel-based Brainsgate have developed a system that uses electrical stimulation to treat ischemic stroke. The system consists of miniature neurostimulator, a...
US Handheld Ultrasound Market Forecast to Exceed $1.2bn by 2016
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...
St Jude and Zonare to Develop and Market Ultrasound System
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...
Edwards Transcatheter Valve Improves Quality of Life, Study Finds
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. ...
Pyng Initiates Voluntary Recall of Sternal Intraosseous Device
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...
FDA Launches External Defibrillator Improvement Programme
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
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...
US Researchers Identify Protein That Could Predict Heart Failure
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),...
NMT Septal Repair Implant Fails Study Goal
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
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...
PWB Health Recalls Breast Cancer Detection Device
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...
Brain Scan Could Predict Paediatric Anxiety Disorder Treatment Outcomes
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
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...
EU Funds Neurodegenerative Diagnostic Device Programme
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...
HeartWare Reports Positive Study Results of Heart Pump
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...
Urine Test Could Diagnose Kidney Injury
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...
Medtronic Reports Positive Cardiac Resynchronisation Device Trial
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...
Arstasis Initiates Patient Enrolment for Femoral Artery Closure System Trial
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...
Mederi Receives CE Mark for Gastric Reflux and Incontinence Devices
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...
Researchers Use Tracking System to Identify Faulty Medical Devices
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...
Scientists Use Microwaves to Monitor Vital Signs
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...
EnteroMedics Reports Results of Obesity Device Studies
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...
UK Researchers Working on Confidential STD Test
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
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
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...
Boston Scientific Initiates Patient Enrolment for Parkinson's Disease System Trial
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. ...
Multidetector CT Could be Used to Identify Stroke Causes
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...
Ultrasound Needle Guidance Found to Improve Knee Injection Outcomes
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
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...
Combined Imaging Technologies Could Improve Breast Cancer Detection
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...
Cardio Surgery Devices Market to Reach $2.4bn in 2016
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...
WalkMed Initiates Infusion Pump Recall
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. ...
Researchers Develop Life Expectancy Test for Terminal Cancer Patients
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...
Covidien Receives Clearance for Venous Thromboembolism System
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...
CARE Fertility Test May Improve IVF Success Rates
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...
Low-Dose CTs Prevent More Lung Cancer Deaths than X-Rays
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...
FDA Reclassifies Digital Mammography Systems as Class II Devices
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...
MiCardia Receives CE Mark for Mitral Regurgitation Device
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...
Atrium Completes Patient Enrolment for iCAST Stent Trial
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...
UK Scientists Develop Jellyfish Protein Cancer Test
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...
Researchers Develop Blood Test for Niemann-Pick Type C Disease
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...
Researchers Develop Eye Implant to Restore Vision
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...
Elderly Women at High Risk of Inappropriate Urinary Catheterisations
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...
JenaValve Launches Aortic Stenosis System Study
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...
Researchers Develop Gender Prediction Test
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...
Clinical Trial Combines Genetic Test with CT Scan to Diagnose Lung Cancer
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...
MRI Could Predict Ischemic Stroke Onset
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...
Medtronic Receives FDA Approval for Thoracic Stent Graft
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...
DNA Electronics and 454 Life Sciences to Develop DNA Sequencing System
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...
FDA Categorises Medtronic Tissue Stabiliser Recall as Class I
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
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
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
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...
Researchers Develop Endoscopic Drug Delivery Device for Colorectal Cancer
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...
ArthroCare Receives US Approval for Suture Implant System
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
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
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 Imaging Technique for Breast Cancer
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
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...
Exact Sciences Reports Positive Study Results for Colorectal Cancer Test
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
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...
October 2010
Top
Portable Scanner Developed to Detect Breast Cancer
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...
Patient Enrolment for Cancer Pain Therapy Study Begins
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. ...
Passive Safety Devices Prevent Needlestick Injuries, Study Suggests
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 Medical Adhesives and Sealants Market to Reach $1.84bn by 2015
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...
CorMatrix Reports Positive Study Results for Pericardial Closure Implant
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
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,...
US Intermittent Catheter Market to Double by 2014
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...
EDAP Completes First Stage of Ultrasound Trial
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
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...
Tengion Reports First Neo-Urinary Conduit Implantation
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...
Emotional Health Monitoring Smart Phone App Released
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
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...
Researchers Develop Synthetic Bone Material
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...
Researchers Develop Blood Test for Chronic Kidney Disease
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...
Biliary Stricture Stent Receives CE Mark
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...
Microchip Could Separate Tumour Cells from Blood Samples
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...
Aethlon Initiates Patient Enrolment for Hemopurifier Study
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 Patient Monitoring Market to Reach $4bn by 2017
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
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
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...
Study Deems Pacemakers Reuse Safe and Effective
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...
US Researchers Awarded Grant for Brain Monitoring Device
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
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...
Spectral Diagnostics Begins Haemoperfusion Device Trial
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
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...
Early Menopause Gene Discovery Could Lead to Predictive Test
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
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...
Devon Medical Receives US Approval for Lymphoedema Pumps
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...
St Jude Medical Acquires AGA Medical
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....
Researchers to Trial Eye Device for Cancer Drug Delivery
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
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...
NinePoint Medical to Develop Cancer Diagnosis Devices
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...
Knee Device Should Not Have Been Approved, Says FDA
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...
UK Scientists to Develop Urine Test for Prostate Cancer
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
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...
PneumRx Receives CE Mark for Emphysema Device
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...
New Tool Could Optimise Cardiovascular Device Design
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...
MRI Shows Promise in Diagnosing Brain Disorders
Researchers at the University of Illinois at Chicago, US, have successfully used brain imaging to differentiate between attention deficit hyperactivity disorder (ADHD) and paediatric...
Positive Results for Vital Therapies Bioartificial Liver System
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...
Biomerix Granted US Patent for Tissue Scaffold
Biomerix Corporation has been awarded a US Patent for its proprietary biomaterial platform technology. Biomerix Biomaterial is a non-resorbable reticulated polycarbonate...
Myriad Prostate Cancer Test Accurately Predicts Survival
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...
Tinnitus Device Performs Well in Trial
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...
Genomic Health Reports Positive Breast Cancer Test Trial
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. ...
Singapore Researchers Develop Device to Predict Heart Failure
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...
Stanford and Varian Scientists Partner to Develop New Imaging Technology
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
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...
Study Suggests MRI Could Help Diagnose Autism
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...
US Researchers Improve CTC Chip
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...
Chinese Cardiovascular Market to Reach $1.6bn by 2016
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
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...
Carotid Artery Stenting Linked to Increased Stroke Risk
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...
Menssana to Develop Breath Test for Radiation Exposure
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...
Researchers Find Biomarkers to Test for River Blindness
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...
Ultrasound Device Could Speed Up Fracture Healing
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...
FDA Awards ALS Device Humanitarian Use Status
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...
Researchers Develop Potential Pre-Screening Test for Lung Cancer
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 –...
Kinetic Hernia Repair Mesh Successful in Trial
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 and CT Scan Use Triples in US
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...
Gene Test Could Reduce Unnecessary Angiograms
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...
Artificial Pancreatic Tissue Offers Hope for Diabetics
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...
Webcam Used for Vital Signs Monitoring
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...
FDA Awards Information Hub Development Contract
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...
Researchers Develop Blood Test for Alzheimer's
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...
MRI Used to Predict Progressive Mild Cognitive Impairment
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...
Ciba Vision Recalls Contact Lenses
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. ...
Urovalve Reveals Positive Study Results of Bladder Management System
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...
NovaBone Receives FDA Approval for Bone Graft Delivery System
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...
Varian and IMRIS to Develop MR-Guided Radiation Therapy System
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...
Deep Brain Stimulation Could Be Used to Treat OCD
Deep brain stimulation could help patients with obsessive compulsive disorder, according to research conducted at Amsterdam University's Academic Medical Center. Sixteen patients with...
Diagnostic X-Rays Found to Increase Childhood Leukaemia Risk
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...
Fluorescent Beads Could End Finger Prick Blood-Sugar Testing
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
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...
Tyton Reveals Positive Study Results for Stent System
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...
Wenzel Receives FDA Approval for Intervertebral Body Fusion System
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...
US Inspectors Reopen Investigation into FDA-Approved Medical Scanners
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
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...
New Breath Test Could Diagnose Cancer and Diabetes
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
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...
St Jude Spinal Cord Stimulation System Approved in Japan
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
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...
ArthroCare Vertebral Augmentation Device Approved in US
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. ...
Microelectronic Device Could Reverse Brain Damage
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...
Cleft Lip and Palate Device Could Reduce Need for Surgery
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
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...
September 2010
Top
Microfluidic Device Developed to Identify Aggressive Breast Cancers
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...
Intrauterine Devices Successfully Used to Treat Endometrial Cancer
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...
CT Scans Could Predict Future Cardiovascular Risk
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. ...
Prostate Cancer Blood Test Could Prevent Unnecessary Biopsies
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
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
Johnson & Johnson has completed its acquisition of Micrus Endovascular, a manufacturer of minimally invasive devices for ischaemic and haemorrhagic stroke. Micrus Endovascular will...
Study Warns of Imaging Risks in Child Cancer Patients
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,...
Laser-Based Devices Could Replace X-Rays in Disease Diagnosis
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,...
Chronic Sinusitis Can be Safely Treated in Clinics, Study Finds
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
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. ...
Latin America's Aortic Stent Graft Market to Reach $150m by 2015
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...
Insulin Pump Improves Diabetes Control, Says Study
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...
Edwards Announces Transcatheter Heart Valve Trial Results
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...
Medical Electrodes Market to Reach $976m by 2015
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...
Blood Test Could Predict Transplant Organ Rejection
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...
Protectus Granted US Patent for Safety Syringe
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...
Prolapse Repair System Proves Efficacy in Trial
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
Abbott Laboratories' MitraClip System has exhibited clinical benefits in a study sponsored by the Cardiovascular Research Foundation. The randomised, multi-centre and prospective...
MRIs Could Be Used for Endovascular Stent Surveillance
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...
Researchers to Develop Emergency Care Device for Astronauts
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...
Zynex to Develop Central Blood Volume Monitoring Device
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...
Bioconnect Receives CE Mark for Optiflow Vascular Anastomotic System
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...
Scientists Develop New Breast Cancer Marker
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...
Trial Proves Biodegradable Polymer Stents Safe and Effective
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...
Corindus Coronary Intervention System Performs Well in Trials
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...
New Test Could Predict Diabetes Onset
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,...
Medtronic Integrity Stent Receives FDA Approval
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...
Scientists Develop Blood Test for Fatty Liver Disease
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...
Elixir Launches Coronary Stent Trial
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 Unveil Artificial Pancreas
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...
Neurostimulation Shows Promise for Migraine Treatment
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 Test Body-Powered Fuel Cell
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...
ResMed CPAP Device Performs Well in Clinical Study
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...
Robotic Heart Catheter Could Improve Atrial Fibrillation Treatment
Researchers at North Carolina State University have developed a computerised robotic catheter that could make atrial fibrillation treatment faster, cheaper and more effective. ...
Stenting for Aortic Coarctation has 77% Success Rate
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
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...
Implant Developed to Treat Hypertension and Heart Disease
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...
Scientists Unveil One-Hour TB Test
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...
Neuroimaging Could Aid Early Diagnosis of Parkinson's
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 ...
Medicare Bidding Programme Could Reduce Equipment Quality
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...
Study Authors Often Fail to Disclose Device Manufacturer Payments
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. ...
Shape Memory Alloys Proven to be Biocompatible
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. ...
Ranier Receives CE Mark for Spinal Disc Replacement Device
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,...
PSA Blood Test Could Determine Prostate Cancer Death Risk
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...
Blood Serum Biomarkers Used to Detect Alzheimer's
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
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....
Researchers to Develop Blood Test for Pre-Eclampsia
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...
Brain Stimulation Can Help Stroke Patients Regain Motor Function
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,...
California Law Could Protect Patients from Medical Radiation
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,...
Routine Re-Siting of Peripheral IVDs May Not Cut Complications
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
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...
GI Dynamic's Gastrointestinal Liner Performs Well in Trial
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...
Teleflex Receives FDA Approval for its Central Catheter
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...
VirtualScopics and ABX-CRO Form Molecular Imaging Partnership
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
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...
AtheroMed Initiates Atherectomy Catheter Trial
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
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. ...
WHO Warns of Major Medical Device Gaps in the Developing World
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
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...
Researchers Develop Titanium Foam for Bone Implants
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. ...
Recalled Breast Implants Show No Evidence of Health Risks
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 Develop Blood Test for Respiratory Viral Infections
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...
Johnson & Johnson Sued Over Hip Replacement Device
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...
Researchers Use Electrical Stimulation to Treat Depression
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...
Myconostica Receives CE Mark for Aspergillus Test
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
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...
Scientists Develop Handheld MRSA and Breast Cancer Test
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...
Study Finds PET/CT Scans Effective at Detecting Breast Cancer Metastases
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...
Plate and Screw Market in Japan to Exceed $170m by 2014: Report
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...
Unilife Receives FDA 510(k) Approval for Tuberculin Syringe
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...
IMEC to Develop Lab-on-Chip Cancer Device
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...
UCSF Researchers Develop First Implantable Artificial Kidney
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...
New Diabetes Test May Not Be Effective
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...
Researchers Develop Miniature Pump for Microneedle Drug Patches
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. ...
Medical Devices Market in Emerging Superpowers Exceeds $10bn
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...
New Rapid Test for Developed TB
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 Device Helps Bilateral Hearing
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)...
Masimo PVI Improves Fluid Management During Surgery
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...
Prometheus Introduces Crohn's Prognostic Test
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...
Quidel's Pregnancy Test Receives FDA 510(k) Clearance
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...
Scientists Develop Rapid Neutrophils Isolating Device
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...
Newer Generation Drug Eluting Stents Effective: Study
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. ...
African-Americans at High Risk of Blood Clots from Drug-Eluting Stents
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...
Researchers Develop MRI Technique to Record Moving Joints and Organs
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,...
Forceps Delivery Increases the Risk of Muscle Damage
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...
Magnetic Resonance Spectography Could Detect Neurological Disorders
Magnetic Resonance Spectography (MRS) can distinguish between different types of neurological degenerative disorders, according to a study conducted by University of Minnesota...
Scientists Use Biosynthetic Corneas to Restore Eyesight
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...
Researchers Develop Plastic Microneedles That Could Help Diagnose Cancer
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...
August 2010
Top
Johnson & Johnson Recalls Contact Lenses
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...
Echo Therapeutics Completes Clinical Trial of its Skin Prep Device
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
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...
Nuclear-Based Breast Imaging Exams Increase Cancer Risk
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...
Intra-Aortic Balloon Pumps May Not Reduce Adverse Cardiac Events
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...
ConvaTec's Continence Control Device Receives EU Approval
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...
Researchers Develop LED-Based Diagnostic Device
Arizona State University researchers have developed a diagnostic device that uses LEDs and microelectronic amplifiers to detect diseases. Integrascope can analyse patient fluid samples...
FDA Warns Johnson & Johnson Over Product Marketing
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...
Radiometer Blood-Gas Analyser Receives FDA Approval
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...
Benvenue Begins Osteoporotic Fracture Implant Trials
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...
Sirtex's Colorectal Cancer Microspheres Prove Effective
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
Researchers from the University of Louisville / Jewish Hospital Cardiovascular Innovation Institute have developed a microvascular construct that can prolong the life of implanted...
Iridex Granted US Patent for Dose Control Laser System
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
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...
New Technique Can Reduce Radiation Doses in CT Scans
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...
Genetic Test Could Herald TB Breakthrough
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
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...
Researchers Develop Protein Coating That Improves Implant Adhesion
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
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...
Binder Biomedical Introduces Spinal Spacer System
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...
Drug-Eluting Stents Improve Clinical Outcomes, Says Study
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
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...
Researchers Develop Imaging Technology for Heart Rhythm Disorder
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...
Scientists to Develop Foetal Surveillance System
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...
BSD Receives FDA Clearance for Microwave Ablation System
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...
Maths Formula Could Lead to Lung Scanning Technology for Newborns
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...
Researchers Develop One-Hour Meningitis Test
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
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...