The FDA today released a warning letter it sent to ReWalk Robotics (NSDQ:RWLK), formerly Argo Medical, over a failure to submit a post-market surveillance report on its ReWalk exoskeleton device addressing issues with injuries during falls while operating the device.
The agency detailed a string of back-and-forth communications between it and the ReWalk maker going back to July 31, 2014, when it submitted its 1st post-market surveillance study plan synopsis.
The robotic exoskeleton maker submitted the synopsis, but it was found to be deficient by the FDA and began a string of delays between the maker and the FDA that stretched to last summer, according to the warning letter.
