Med City News -- Following a February warning letter from the U.S. Food and Drug Administration, Anulex Technologies has had to adjust by having a round of layoffs.
President and General Manager Tim Miller declined to say how many people were let go but acknowledged that such letters were “extremely disruptive to business. ”
The Minnetonka, Minnesota-based medical device company develops products for soft tissue repair.
The FDA had granted Anulex a 510(k) approval for the Xclose soft tissue repair system to be used for general and orthopaedic surgery. But after the company did a post-market study to see how Xclose performed when used to repair the annulus, the FDA took offense because the company had not applied for an investigational device exemption prior to doing so.