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. Tyber Medical wins FDA 510(k) for TyWedge
Tyber Medical said it won FDA 510(k) clearance for its TyWedge osteotomy wedge system.
The TyWedge is a titanium plasma sprayed PEEK indicated for fusion in osteotomy operations, and allows for angular corrections in the foot, according to the Morristown, N.J.-based company. Read more
2. HealthWatch wins CE Mark for remote ECG monitor
HealthWatch Technologies said it won CE Mark approval in the European Union for its MasterCaution remote electrocardiogram monitor.
The newly approved device from Israel-based HealthWatch conditions ECG signals for digial transmission via Bluetooth to connect to smartphones or other communications devices, the company said. Read more
1. GI Dynamics slashes workforce by 46%
GI Dynamics said it will slash its workforce by 46% by the end of the year, cutting about 25 jobs, after a too-high rate of liver infections forced the halt of a U.S. clinical trial for its EndoBarrier weight loss device.
The Lexington, Mass.-based firm said it was making the cuts to cover the cost of shutting down the trial and to make sure it has enough cash “to ensure sufficient cash remains available to establish new priorities, continue limited market development and research, and to evaluate strategic options.” Read more