Warning Letter: Exoskeleton Firm Dodged Communication With FDA Over Postmarket Study, Failed To Assemble Surveillance Plan
This article was originally published in The Gray Sheet
Executive Summary
An FDA warning letter sent to Argo Medical Technologies, now named ReWalk Robotics, outlines the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The missive to Argo also lays out a timeline of events that describes how the agency chased after the company.