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.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
3. Globus says $1M FDA result of “unfortunate miscommunication”
Orthopedic device maker Globus Medical chalked the $1 million settlement with the FDA up to an "unfortunate miscommunication" rather than to any patient safety problems with its NuBone bone graft products.
2. Weight loss: GI Dynamics: U.S. clinical trial on tap for this year
GI Dynamics (ASX:GID), in its first earnings release as a publicly traded firm, said it’s hoping to start a U.S. clinical trial of its EndoBarrier weight-loss and diabetes device this year.
1. MDUFMA: Industry and FDA leave the table with drafts in hand
The 3rd iteration of the FDA’s medical device user fee program rolls ever closer to finalization, as the watchdog agency and industry players move forward with a draft of the legislative language.