FDA approves ReWalk system for patients with lower body paralysis- ReWalk Robotics
The FDA has allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a Spinal Cord Injury.
The FDA reviewed the ReWalk through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low-to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., (now ReWalk Robotics) the manufacturer of ReWalk, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.
The system was given CE Mark in 2010.
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