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. SEC closes InVivo Therapeutics probe
InVivo Therapeutics said today that the U.S. Securities & Exchange Commission ended a probe of the regenerative medicine company and doesn’t plan to recommend any enforcement action.
Cambridge, Mass.-based InVivo said in January that the SEC’s Boston office subpoenaed documents concerning former CEO Frank Reynolds and ex-acting CFO Sean Moran and “certain other corporate events.” Read more
2. AirXpanders pivotal IDE trial meets endpoint
AirXpanders said the pivotal investigational device exemption trial of its AeroForm tissue expander met its primary endpoint. Results from the trial were presented at the American Society of Plastic Surgeon’s meeting in Boston.
The AeroForm tissue expander is designed for use in post-mastectomy breast reconstructions to expand and stretch the skin and underlying muscle prior to a permanent breast implant, the Palo Alto, Calif.-based company said. Read more
1. Transcend Medical finalizes PMA bid for CyPass glaucoma stent
Transcend Medical said today that it filed the final module in its pre-market approval application with the FDA for the CyPass micro-stent glaucoma treatment.
Menlo Park, Calif.-based Transcend said the PMA bid is based on its Compass trial, which met its primary endpoint of 20% or greater reduction in intraocular pressure. The 500-patient study of subjects with mild to moderate glaucoma compared CyPass plus cataract surgery with cataract surgery alone. Read more