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 […]
Argo Medical Technologies Ltd.
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FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.
Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit’s movements and patients rely on crutches to provide stability.
Argo Medical’s exoskeleton coming to America: The Daily Mail reported that Argo Medical Technologies Ltd. will soon be making its ReWalk exoskeleton available in the United States for people paralyzed in the legs. The device provides power and walking motion, but balance has to be maintained by using forearm crutches.