A robotic exo-suit system for the treatment of stroke survivors with gait impairment has been cleared by the FDA for sale to U.S. rehabilitation facilities, Marlborough, Mass.-based ReWalk Robotics announced this week.
The ReStore soft exo-suit comprises a lightweight waist pack and mechanical cables that help a patient lift their legs in time with their natural gait. It also provides real-time analytics to physical therapists so they can customize a patient's treatment plan for optimal progress.
The exo-suit's launch price for rehab clinics will be $28,900, with leasing options available. A multicenter clinical study demonstrating the ReStore system's efficacy in aiding patients with mobility challenges is expected to be published later this year.
ReStore was initially developed at Harvard University's Wyss Institute for Biologically Inspired Engineering. ReWalk and the Wyss Institute launched a multi-year research collaboration in 2016, granting ReWalk rights to the exo-suit and future innovations stemming from this technology, including projects currently in progress to treat patients with multiple sclerosis and Parkinson's disease.
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