FDA Allows Marketing of Exoskeleton Device for Paraplegic Spinal Cord Injury Patients

The U.S. Food and Drug Administration has allowed marketing of the first motorized device, which acts as an exoskeleton for those with paraplegia due to a spinal cord injury, called ReWalk.

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The motorized device is worn over the legs and part of the upper body, and it helps an individual sit, stand and walk with assistance from a trained companion. ReWalk is for people with paraplegia due to spinal cord injuries at levels T7 to L5 when accompanied by a specially trained caregiver. It is also for people with spinal cord injuries at levels T4 to T6, where the device is limited to use in rehabilitation institutions.

 

ReWalk was manufactured by Argo Medical Technologies, and the company is required to complete a post-market clinical study, according to the FDA.

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