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 news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. MedyMatch looks to future of stroke detection with AI platform launch
Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain bleeds is now available for research.
The development is a milestone for the company, but is only the 1st stop for the platform, CEO Gene Saragnese told MassDevice.com in an interview. Read more
4. Invendo Medical wins CE Mark for Invendoscope SC200
Invendo Medical said today it won CE Mark approval in the European Union for its Invendoscope SC200, which it touts as the world’s 1st sterile, single-use colonoscope.
The German company said its device is designed to eliminate the complex reprocessing of endoscopes that create a serious risk of cross-contamination and the culturing of resistant bacteria. Read more
3. FDA clears Kyocera Medical’s Initia hip implant
Implantable medical systems maker Kyocera Medical said today it won FDA 510(k) clearance for its Initia total hip implant system.
The Japanese company’s Initia total hip system includes Bioceram Azul zirconia-toughened alumina ceramic femoral heads, or can be requested with cobalt chrome femoral heads. Read more
2. Medtronic wins expanded CE Mark indication for Endurant II stent graft
Medtronic said today that it won an expanded CE Mark indication in the European Union for its Endurant II/IIs stent graft for treating abdominal aortic aneurysms.
The expanded indication covers a new endovascular implantation approach using a parallel graft chimney approach called ChEVAR, which allows the device to be used to treat aneurysms with an aortic neck length of 2mm or more. Aortic neck length is the distance from the renal arteries to the aneurysm. Read more
1. Neovasc surges on early data for Tiara mitral valve implant
Neovasc said today that early clinical data on its Tiara transcatheter mitral valve replacement showed an 86% technical success rate and 100% freedom from mild, trace or absent paravalvular leakage.
The Vancouver-based company, which last month won approvals for a 115-patient CE Mark trial of the Tiara valve in Italy, said 22 patients have been implanted with the valve in the U.S., Canada and Europe. Results from those cases were presented in Tel Aviv this week at the annual ICI Meeting by Neovasc medical director Dr. Schmuel Banai. Read more
