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. Sunshine Heart taps Boston Scientific R&D vet for ops role
Sunshine Heart said it named Brian Brown, a longtime Boston Scientific R&D veteran, as its new operations & technology vice president.
Brown, who was vice president of cardiovascular research for Boston Scientific for the past decade, has logged 24 years in the medical device industry, according to a press release. His career began with SciMed Life Systems, which Boston acquired in 1994, according to the release. Read more
2. FDA cuts back oversight of medical device data systems
MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can’ skip the 510(k) process for premarket clearance.
The proposed change in regulation affects a wide range of devices, including wireless scales and glucose meters. Read more
1. Medtronic got hacked, company reveals
Medtronic revealed today that it was the target of a digital attack sometime in 2013, seeming to confirm rumors that circulated earlier this year regarding a hack of some of the medtech’s top players.
Medtronic reported in regulatory filings that it and 2 other unnamed “large medical device manufacturers” were targeted by hackers appearing to originate from Asia. Those infiltrators didn’t breach any patient data, Medtronic assured regulators. Read more