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. Orthofix CFO bails after 6 months amid deepening financial fix
Orthofix CFO Mark Heggestad is stepping down just 6 months into his tenure, even as the medical device company’s 3-year financial restatement yesterday deepened on new problems with its inventory controls.
Orthofix promoted its chief accounting officer Doug Rice to replace Heggestad, who took over May 9 from interim CFO David Ziegler. Longtime CFO Emily Buxton had been replaced in April after a decade as Orthofix’s financial chief. Heggestad, who is slated to stay on as an outside consultant, is leaving due to “personal circumstances,” Orthofix said. Read more
2. FDA guides on custom devices
The FDA yesterday released its final recommendations for legal exemptions for customized medical devices that deviate from already-approved systems by being tailored to the special needs of up to 5 patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very tall people or infants that are otherwise unavailable in the correct size. Read more
1. Diabetes: Medtronic readies smartphone-enabled CGM
Medtronic is gearing up for a pivotal clinical trial of a smartphone-enabled continuous glucose monitor it’s developed, according to MobiHealthNews.
The smartphone CGM is designed to connect Medtronic’s Guardian glucose monitor with an iOS app for iPhones, Medtronic global program marketing manager Samantha Katz revealed at Health 2.0 in Santa Clara, Calif. the website reported. Read more