Clik here to view.
Philips wins 510(k) for MR suite patient monitor system
Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its Expression MR400 monitor designed for patients undergoing magnetic resonance imaging. The MR400 is designed to provide...
View ArticleClik here to view.
Titan Medical expands offering to $8m
Titan Medical (CVE:TMD) today shifted the size of its upcoming offering, which it previously expected to bring in $6 million (C$8 million) raising the amount of shares offered to put it in the range of...
View ArticleClik here to view.
BD wins FDA nod for HIV/AIDS diagnostic
Becton Dickinson & Co. (NYSE:BDX) said today it won FDA 510(k) clearance for its FACSPresto system and CD4/Hb cartridge designed as an HIV/AIDS diagnostic. The Franklin Lakes, N.J.-based company’s...
View ArticleClik here to view.
TransEnterix finalizes response to FDA over 510(k) for SurgiBot
TransEnterix (NYSE:TRXC) said today it finalized its response to the FDA in relation to the 510(k) application for its SurgiBot system. Research Triangle Park, N.C.-based TransEnterix says the SurgiBot...
View ArticleClik here to view.
OrthoCor picked up by veterinary med device firm Caerus Corp
Non-invasive medical device maker OrthoCor said yesterday it was acquired by veterinary-focused medical device firm Caerus Corp, who said the company will remain independent and focused on the...
View ArticleClik here to view.
Fonar taps MR scan inventor and founder’s son as CEO | Personnel Moves
Fonar Corp (NSDQ:FONR) said yesterday it named Timothy Damadian, son of magnetic resonance scanning inventor and company founder Dr. Raymond Damadian, as its new president and CEO. The younger...
View ArticleClik here to view.
MassDevice.com +3 | The top 3 medtech stories for February 10, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
View ArticleClik here to view.
FDA announces traumatic brain injury biomarker workshop
The FDA today announced plans for a workshop to discuss the development of technologies for detecting biomarkers related to traumatic brain injuries. The aim of the workshop is to discuss both the...
View ArticleClik here to view.
FDA: Dräger Med transport ventilator recall is Class I
The FDA today issued a recall for Dräger Medical‘s emergency transport ventilators over a system error that can lead to a a halt in ventilator function, labelling the recall as Class I. The FDA labels...
View ArticleClik here to view.
NxStage slumps despite Q1, FY2015 beats
NxStage saw shares plummet after releasing earnings that barely squeaked by Street expectations for their 4th quarter and full fiscal year 2015. The Lawrence, Mass.-based company reported losses of...
View ArticleClik here to view.
Final independent assessment of FDA’s premarket review process released
By Stewart Eisenhart, Emergo Group The final results of an independent evaluation of the US Food and Drug Administration’s medical device review program have been published, giving the agency high...
View ArticleClik here to view.
Cook Medical recalls select single lumen caths
Cook Medical is recalling 360 lots of its single lumen central venous catheters, pressure monitoring sets and trays due to issues with catheter tip fracture and separation. A total of 17,872 devices...
View ArticleClik here to view.
Microsoft and Novartis partner to use gaming sensor to “Assess MS”
Microsoft (NSDQ:MSFT) is looking to use its Kinect computer vision system for more than just games. The tech giant said this week it is partnering with Novartis (NYSE:NVS) to develop a system for...
View ArticleClik here to view.
Fresenius’ Frenova launches clinical trial accelerator
Dialysis giant Fresenius‘s (NYSE:FMS) renal research branch Frenova said today it launched a renal research accelerator, titled F1RST Up, through an alliance of physician investigators in the...
View ArticleClik here to view.
Biotronik wins Japanese clearance for MR-safe Itrevia CRT-D
Biotronik said today it won Japanese regulatory clearance for its Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, now approved for full-body MRI-scanning. With the clearance, physicians...
View ArticleClik here to view.
Cerus inks supply deal with Red Cross
Cerus Corp. (NSDQ: CERS) said this week that the American Red Cross inked a multi-year purchase agreement for its Intercept blood system designed to reduce the risk of transfusion-transmitted...
View ArticleClik here to view.
Biomaterial startup Regentis raises $15m
Israeli start-up Regentis Biomaterials said yesterday it raised $15 million in a Series D round of funding to support its GelrinC hydrogel-based resorbable cartilage replacement. Funds from the round...
View ArticleClik here to view.
Portable oxygenation device maker Hemovent raises $6m
German medical device developer Hemovent said yesterday it raised $6m in a Series A round to support its portable extra corporeal membrane oxygenation system. The oxygenation system is designed to...
View ArticleClik here to view.
Avita inks deal with EU distro deal with MSM Medical
Avita Medical (ASX:AVH) said today it inked a distribution deal with MSM Medical that will put the company in charge of selling its devices into the German, Austrian and Swiss markets. German-based MSM...
View ArticleClik here to view.
Five things to consider when adding bluetooth to medical devices
By Michael Cassidy, Emergo Group Medical device manufacturers are increasingly adding wireless technology to their products, but how does this trend impact regulatory compliance? From cellular links to...
View Article