Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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.
Dexcom Inc. said the FDA flagged its adverse event reporting system for not being compliant with new medical device reporting rules.
The federal watchdog agency issued a warning letter to San Diego-based Dexcom, which makes continuous glucose monitors for diabetics, after an inspection in November 2013, according to a press release. Read more
Israel-based Medigus won FDA clearance for the next generation of its MUSE technology, a minimally invasive technology for performing surgeries to treat acid reflux disease.
The new device features an enhanced user interface and new updates to its endoscopic camera, as well as a motorized stapling system, alignment controls and a more compact console. Previous features such as the ultrasound guidance system remain in place, according to a press release. Read more
Transcatheter Technologies GmbH touted 6-month results from a pilot study of its Trinity transcatheter aortic valve implantation system, reporting no instances of valve leakage.
Paravalvular leakage is an important indicator of mortality risk in TAVI procedures. Early generations of devices were marred with post-implantation leakage in the replacement valve and new technologies have taken steps to stem that risk. Read more