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Warning Letter: Exoskeleton Firm Dodged Communication With FDA Over Postmarket Study, Failed To Assemble Surveillance Plan

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.

FDA sent Argo Medical Technologies Inc. a warning letter

outlining the company's failure to conduct mandatory postmarket surveillance activities on its ReWalk bionic walking assistance system. The letter also details how the manufacturer dodged multiple communication attempts made...

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