The stock of robotic medical device maker Rewalk Robotics soared 40% on Friday after the Food and Drug Administration granted its ReBoot device Breakthrough Device Designation.
In early morning trading, the stock of Rewalk Robotics is trading at $1.81.
"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," stated Larry Jasinski, CEO of ReWalk.
The ReBoot gadget, developed by the Massachusetts-based company, is a battery-powered orthotic exo-suit designed to aid mobility in persons who have lost ankle function due to neurological traumas such as a stroke.
The Breakthrough Device designation expedites the development, appraisal, and review of medical devices so that patients can have them sooner.
The device, according to Jasinski, will “give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community”
The gadget will now be submitted to the FDA for approval. It will finish the design and development before moving on to the clinical trials that are required.