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. Diabetes: Dexcom wins CE Mark for G5 CGM
Dexcom said that it won CE Mark approval in the European Union for its G5 continuous glucose monitor, saying it expects to have the device available in several countries there in the coming weeks.
San Diego-based Dexcom won pre-market approval from the FDA for the G5 device last month, touting it as the 1st approved CGM system to send data directly to smartphones without a separate receiver. Read more
2. Valtech Cardio wins CE Mark for Cardioband mitral repair device
Valtech Cardio, which agreed to be acquired by HeartWare International, said it won CE Mark approval in the European Union for its Cardioband mitral valve repair device.
Or Yehuda, Israel-based Valtech said it plans to unveil the Cardioband device at the PCR London Valves meeting in Berlin next week. Read more
1. FDA approves Medtronic’s Evera MRI SureScan ICD
Medtronic said that the FDA granted pre-market approval for its Evera MRI SureScan device, touting it as the 1st MRI-safe implantable cardiac defibrillator to win U.S. approval.
Fridley, Minn.-based Medtronic said the Evera device is approved for MRI scans of any body area. The device is expected to hit the market this month, including the ICD itself and Medtronic’s Sprint Quattro Secure MRI SureScan DF4 leads, which are required for the MRI-safe designation. Read more