ReWalk Reboot Device: Granted Device Designation by FDA

Nov 5, 2021 By MarketDepth

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FDA Approved

ReWalk Robotics, Ltd. (NASDAQ: RWLK) has reported that its ReBoot device has been granted designation as a Breakthrough Device by the Food and Drug Administration.  The ReBoot is a light, battery powered orthotic exo-suit that is intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, i.e. a stroke.  The ReBoot is customizable and intended for home and community use as its sister product to the ReStore device, received FDA clearance in 2019 for use in the rehabilitation setting.  “Breakthrough device designation from the FDA is a critical milestone for the ReBoot, as it provides a more streamlined review pathway that can get this uniquely innovative device to market faster,” said Larry Jasinski, CEO of ReWalk. “The ReBoot will give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community.”

Helps Affected Leg

The ReBoot works with muscles of the affected leg to assist individuals with maintaining safe foot positioning, including pushing off the ground to improve their gait.  It can facilitate muscle re-education, prevent retard disuse atrophy, improve walking speed and endurance independent of the device and much more.