News, views and contacts from the global Medical industry
 

News Archive

Archive of industry news from the global medical industry

News By Date

April 2015

Top

FDA grants IDE approval for Moirai to start clinical trial of PIR knee system
17 April 2015 The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for US-based implant development firm Moirai Orthopaedics to begin the clinical trial of...

Vascular Flow Technologies reports positive study results of Spiral Flow AV graft
17 April 2015 UK-based medical device firm Vascular Flow Technologies (VFT) has reported independent study results showing substantially better primary patency rates for its Spiral Flow arteriovenous (AV)...

Aethlon Medical and UCI enter cancer clinical trial agreement
16 April 2015 US-based therapeutic devices developer Aethlon Medical has entered an investigator-initiated cancer clinical trial agreement with the University of California (UCI), Irvine,...

Insulin Angel medication tracker launched on Indiegogo
15 April 2015 Insulin Angel, a temperature and proximity tracking device that connects to an individual's smartphone app, has been launched on crowd funding platform...

Royal Philips launches CareSage predictive analytics engine
15 April 2015 Royal Philips has launched a new predictive analytics engine, CareSage, which allows health systems to better monitor and offer care for elderly patients by combining actionable insights...

Tendyne starts patient enrolment in US transcatheter mitral valve replacement trial
14 April 2015 US-based medical device firm Tendyne Holdings has started patient enrolment in its multi-centre global feasibility trial of its Tendyne Bioprosthetic Mitral Valve (TMVR) system in patients...

FDA grants clearance for ivWatch Model 400 monitoring device
13 April 2015 US-based medical device maker ivWatch has received clearance from US Food and Drug Administration (FDA) for its first-of-its-kind continuous monitoring device, ivWatch Model...

FDA grants clearance for Inova Diagnostics' NOVA View IFA microscope
13 April 2015 The US Food and Drug Administration (FDA) has granted clearance through the de novo classification process for Inova Diagnostics' NOVA View, an automated digital indirect fluorescent assay...

Mobidiag launches Amplidiag qPCR-based test
10 April 2015 Finnish molecular diagnostics company Mobidiag has launched Amplidiag C difficile+027, a qualitative qPCR-based test carried out using DNA extracted from stool in suspected cases of...

Health Canada grants marketing approval for HeartWare Ventricular Assist System
10 April 2015 Health Canada has granted marketing approval for US-based HeartWare International's Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart...

University of Bath develops new biochip device for cancer drug development
09 April 2015 A team of researchers from the University of Bath have developed aPhosphoSense biochip device, which will help speed up the discovery of new life-saving drugs in a more cost effective...

Luminex launches new NxTAG RUO test for respiratory testing
08 April 2015 US-based biotechnology firm Luminex has launched a new NxTAG Respiratory Pathogen Panel (RUO) test, which enables laboratories to simultaneously detect 22 respiratory pathogens in a single...

FDA clears Synaptive Medical's BrightMatter Guide system
08 April 2015 The US Food and Drug Administration (FDA) has granted clearance for Canada-based developer of neurosurgery products Synaptive Medical's BrightMatter Guide system for use in operating...

FDA approves GEBT for diagnosis of gastroparesis
07 April 2015 The US Food and Drug Administration (FDA) has granted approval for Advanced Breath Diagnostics' Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of...

FDA grants 510(k) clearance to AirStrip's Sense4Baby for patient self-administration
02 April 2015 US-based AirStrip Technologies has received a second 510(k) clearance from the US Food and Drug Administration (FDA) for Sense4Baby wireless maternal l/ fetal monitoring system for use by...

Roche launches protein melting application for LightCycler 1536 instrument
01 April 2015 Roche has launched a new fully automated protein melting application for its high-throughput, real-time PCR LightCycler 1536...

SynCardia receives FDA approval to conduct new IDE trial of 50cc Total Artificial Heart
01 April 2015 SynCardia Systems has received US Food and Drug Administration (FDA) approval to conduct an investigational device exemption (IDE) clinical trial on the effective use of its 50cc temporary...

March 2015

Top

Medtronic receives Japanese approval for its CoreValve System
31 March 2015 Ireland-based medical technology firm Medtronic has received approval from the Japanese regulatory authority for its self-expanding transcatheter CoreValve system to treat patients with...

Ventripoint gets FDA acceptance notification for expanded use of VMS heart analysis system
30 March 2015 Ventripoint Diagnostics has received an acceptance review notification concerning its recent 510(k) submission to US Food and Drug Administration (FDA) to expand the use of Ventripoint...

Zimmer launches XtraFix external fixation system
30 March 2015 US-based medical device firm Zimmer Holdings has launched a new external fixation system, XtraFix, for the treatment of trauma...

Bioness begins pilot study of StimRouter neuromodulation device to treat overactive bladder
27 March 2015 US-based Bioness has started a Canadian pilot study of the StimRouter Neuromodulation System for the treatment of overactive bladder...


cachename:Newscachekey:rd-1665407042_1857678299_rd-488908060_1243308781_ap1243308781_1857678299_-714335203