RWLK - ReWalk Robotics surges on gaining FDA Breakthrough Device designation for ReBoot device

ReWalk Robotics (NASDAQ:RWLK) is trading 51.94% higher pre-market after receiving the Breakthrough Device designation for its ReBoot device from the FDA. With this designation, ReWalk will now readily pursue the FDA approval pathway for the ReBoot. The ReBoot is a battery-powered orthotic exo-suit designed to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The device works in conjunction with the muscles of the affected leg to assist individuals not only with maintaining safe foot positioning but also with pushing off the ground. It may also facilitate muscle re-education, particularly of plantarflexor function; prevent/retard disuse atrophy; maintain or increase joint range of motion; improve walking speed and endurance independent of the device; and reduce incidence of falls. "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

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ReWalk Robotics surges on gaining FDA Breakthrough Device designation for ReBoot device