Clik here to view.
FDA warns on using Custom Ultrasonics device on duodenoscopes
The FDA today reiterated its warning not to use the an automated endoscope reprocessor made by Custom Ultrasonics with a type of ‘scope called duodenoscopes, which have been linked to deadly “superbug”...
View ArticleClik here to view.
Jury convicts ex-banker in healthcare insider trading trial
After signaling last week that it might be headed for deadlock, a federal jury today convicted an ex-investment banker on insider trading charges related to a quintet of medical device and life science...
View ArticleClik here to view.
Merz buys tattoo-removal company ON Light Sciences
Healthcare company Merz said today it picked up On Light Sciences, makers of the DeScribe Transparent perfluorodecalin patch designed for laser tattoo removal, for an undisclosed amount. Raleigh,...
View ArticleClik here to view.
Molex buys Phillips-Medisize
Electronics developer and interconnected solutions company Molex said today it is buying Phillips-Medisize for an undisclosed amount, with an expected closing date in the fall. Hudson, Wisc.-based...
View ArticleClik here to view.
FDA sends warning letters to 12 medical device companies
The FDA today published the warning letters it sent recently to 12 medical device companies in the U.S. and overseas for violations found during recent inspections. The federal safety watchdog’s...
View ArticleClik here to view.
Levita Magnetics wins de novo FDA clearance for gallbladder surgery device
Medical device developer Levita Magnetics said today it won FDA de novo clearance for its magnetic surgical system with indications for gallbladder removal surgery, and launched the system in the U.S....
View ArticleClik here to view.
FDA adds new clearance for Cianna Medical’s Savi Scout breast cancer locator
Cianna Medical said today it won additional FDA 510(k) clearance for its Savi Scout radar localization breast cancer device, now cleared to be placed at the lumpectomy site up to 30 days prior to...
View ArticleClik here to view.
MassDevice.com +5 | The top 5 medtech stories for August 17, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
View ArticleClik here to view.
Three ways to get more out of your field inventory team
If you operate in the orthopedic, tissue, biologics, or any other space that leverages a combination of loaner and consignment inventory, you likely have a field sales team. This team represents your...
View ArticleClik here to view.
Fresenius Kabi unveils $250m expansion for Ill. plant
Fresenius (NYSE:FMS) business group Fresenius Kabi said today it is investing approximately $250 million over 10 years to expand its Melrose Park manufacturing site. The Lake Zurich, Ill.-based...
View ArticleClik here to view.
California Life Sciences Assn. and OCTANe ink deal
The California Life Sciences Association today said it inked a deal with Orange County life science and tech accelerator OCTANe to “accelerate the growth of Orange County’s life sciences sector.”...
View ArticleClik here to view.
B. Braun integrates Infusomat Space pump with Epic’s EMR system
B. Braun Medical said today it completed system integrations of its Infusomat Space Pump with Epic’s integrated EMR system. Get the rest of the story at our sister site, Medical Design &...
View ArticleClik here to view.
Study: Revascularization beats medical management for intermittent...
Revascularization through endovascular or surgical interventions may be superior to medical management for peripheral artery disease patients with intermittent claudication, according to a new study...
View ArticleClik here to view.
US FDA reduces medical device 510(k) registration fees 10% for 2017
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s medical device registration user fees for the agency’s 2017 fiscal year have decreased nearly across the board, including 10%...
View ArticleClik here to view.
TAVR: Deaths prompt Medtronic warning on EnVeo R delivery system
Reports of nearly 40 vascular trauma events – including 19 deaths– with the EnVeo R replacement heart valve delivery catheter prompted Medtronic (NYSE:MDT) this month to warn doctors not to force...
View ArticleClik here to view.
Legal war erupts between ResMed, Fisher & Paykel Healthcare over sleep apnea...
A legal war erupted this week between sleep apnea device makers ResMed (NYSE:RMD) and Fisher & Paykel Healthcare (NZE:FPH), with lawsuits flying in the U.S., Germany, New Zealand and the U.S....
View ArticleClik here to view.
ReVision Optics takes out $10m credit line for Raindrop inlay
ReVision Optics said today that it took out a $10 million credit line with Pacific Western Bank subsidiary Square 1 Bank as it looks to build out its commercial operation after winning FDA approval for...
View ArticleClik here to view.
After 60 years in Utah, Becton Dickinson to put $20m into Sandy facility
Becton Dickinson (NYSE:BDX) is marking 60 years at its facility in Sandy, Utah, by pledging a $20 million upgrade to the facility, which makes IV catheters and valves, blood collection devices and...
View ArticleClik here to view.
Spectral Medical eyes final PMA bid by year-end for Toraymyxin anti-sepsis...
Spectral Medical (TSX:EDT) said today that it plans to file its final pre-market approval module with the FDA for its sepsis treatment by the end of the year, after the impending release of primary...
View ArticleClik here to view.
HeartWare recalls some HVAD implantable heart pumps on electrical fault risk
HeartWare International (NSDQ:HTWR) this week recalled some of its HVAD implantable heart pumps on the risk of electrical faults from driveline contamination. The recall affects an unspecified number...
View Article