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 day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Angiodroid yanks 510(k) over FDA CO2 clearance issue
ADM Tronics Unlimited said Angiodroid Americas withdrew its FDA premarket notification 510(k) application for the Angiodroid CO2 injector for angiography over lack of clearance for CO2 related to the indication.
The Angiodroid device is an automatic injector for peripheral angiography that used CO2 gas which the company claims eliminates issues with iodine contrast medium that can be poorly tolerated by diabetic or nephropathy patients. The device also reduces the risks and pain associated with the manual injection of CO2. Read more
2. Reva Medical mulls U.S. IPO next year
Reva Medical is reportedly considering listing its shares on the U.S. stock market next year as it gears up to commercialize its Fantom absorbable stent.
Reva, which is based in San Diego, lists its shares on the Australian stock exchange but is mulling a move to the NASDAQ exchange here, founder & chairman Bob Stockman told the Sydney Morning Herald. Read more
1. Medtronic wins FDA panel date for DIAM spine stabilization system
Medtronic won a date with an FDA advisory panel for its DIAM spinal stabilization system.
The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel is slated to meet Feb. 19, 2016, to consider the pre-market approval application for the DIAM system, the FDA said. DIAM stands for “device for intervertebral assisted motion.” Read more
