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First Exoskeleton Suit Receives FDA Clearance

Jun 7, 2019 | Innovation

Marlborough, Mass.-based ReWalk Robotics has received clearance from Food and Drug Administration for the company’s ReStore soft exo-suit system designed for U.S. rehabilitation centers. ReStore is the only soft exo-suit with FDA clearance, and is intended for use in the treatment of stroke survivors with mobility challenges.

The cost for ReStore will hover around the $100,000 mark, putting it out of reach for most patients but not rehab facilities. The technology should improve and lower costs. The global stroke management market is forecast to reach $37 billion by 2023, according to Allied Market Research.

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