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June 27, 2014

ReWalk's home exoskeleton system gets FDA nod

The federal government has given the go-ahead for a Marlborough company to market its wearable robotic exoskeleton for individuals with spinal cord injuries, the company said.

Marlborough-based ReWalk Robotics announced Friday that the U.S. Food and Drug Administration has cleared the company's ReWalk Personal System, which provides powered hip and knee motion that it says will enable individuals to stand upright and walk.

The FDA’s marketing clearance was granted via a process that involved multiple clinical studies demonstrating safety and effectiveness of the technology, the company said.

The ReWalk Personal System is the company’s second product, joining its ReWalk Rehabilitation system, which the company said has produced for several years, and is used in clinical rehabilitation, where it provides a means of exercise and therapy.

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