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FDA Clears ReWalk Exoskeleton System for Curbs and Stairs

March 13, 2023

ReWalk Robotics’ exoskeleton has received an additional FDA clearance for paralyzed individuals with spinal cord injuries to walk on stairs and curbs, instead of only flat surfaces.

The customized battery-powered rigid exoskeleton bears its own weight and has motors at the hips and knees that allow users to walk with a natural gait. The user controls movement using buttons at the wrist and from subtle changes in trunk motion while walking.

The upright mobility helps mitigate complications associated with spinal cord injuries, including bone density, bowel and bladder function, pain management, body composition and cardiovascular function, the company said.

The system previously received a Breakthrough Device designation from the FDA and a CE mark certification in Europe.

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