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Investing.com — Shares of robotic medical device manufacturer Rewalk Robotics Ltd (NASDAQ:RWLK) jumped 40% on Friday after it was awarded Breakthrough Device Designation by the Food and Drug Administration for its ReBoot device.
Rewalk Robotics stock is trading at $1.81 in early morning trading.
“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 Massachusetts-based company’s ReBoot device is a battery-powered orthotic exo-suit intended to help mobility in people with reduced ankle function linked to neurological injuries, such as a stroke.
The Breakthrough Device designation expedites development, assessment, and review to give patients quicker access to medical devices.
Jasinski said the device 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 company will now go down the FDA approval route for the device. It will first finalize the design and development and will then advance to the clinical studies required.
