ReWalk Robotics is a Marlborough, Massachusetts-based company that specializes in wearable assistive robotic medical devices for patients with lower-limb disabilities. We have written about ReWalk technologies multiple times, starting with in 2014 when Alfred Poor covered ReWalk’s FDA approval for the original ReWalk robotic exoskeleton. Last month ReWalk issued a news release; the FDA has awarded Breakthrough Device Designation to the ReWalk ReBoot Soft Exo-Suit.

ReWalk developed the ReBoot device to assist people who are disabled with reduced ankle function due to neurological damage, often from strokes. The ReBoot is a customizable device that patients can use to assist with walking at home or in their community. In 2019 the FDA cleared ReWalk to market the ReStore device, an exosuit with the same purpose as the ReBoot, but designed for use in medical and rehab facilities.

The ReBoot device helps patients by supporting the leg and foot for safe positioning and to assist with pushing off the ground with each step. Patients who use the ReBoot may improve their gait and help their muscles re-learn how to work, especially plantarflexor function. Other potential benefits of the ReBoot include less muscle atrophy from disuse, better range of joint motion, great speed, and endurance while walking, along with fewer falls.

The FDA awards the Breakthrough Device designation to help patients get faster access to treatment or diagnosis of diseases or conditions that are life-threatening or irreversibly debilitating. The Breakthrough designation is not FDA approval to market a device for a specific purpose, but it expedites device review and assessment. In a sense, the Breakthrough Device program is similar to the FDA’s Emergency Use Authorization (EUA) that allowed medical providers to administer COVID-19 vaccines before the conventional testing regimens were complete. Vaccines still had to complete the FDA testing process for full approval, but the EUA cut the waiting time to administer vaccines by months. The Breakthrough program doesn’t change the approval process, but it does speed it up. With this designation, ReWalk can now proceed with the ReBoot’s development and design in order to begin clinical studies as soon as possible.