FDA regulators announced this evening that they approved for the U.S. market the 1st robotic exo-suit for helping patients with lower-body paralysis walk upright.
Called ReWalk , the motorized system is comprised of metal leg braces that strap around the legs and back, supplying movement to joints in the hips, knees and ankles. The system includes a watch-based remote that controls the suit’s movements and patients rely on crutches to provide stability.
ReWalk was approved for patients with spinal cord injuries, requiring that they also a trained caregiver on hand when using the device. Outpatient use was approved for patients with injuries at levels T7 (7th thoracic vertebra) to L5 (5th lumbar vertebra), while patients with injuries levels T4 (4th thoracic vertebra) to T6 (6th thoracic vertebra) will only have access to the device in rehabilitation clinics, the FDA said.
ReWalk was developed by Argo Medical Technologies, a company founded by Dr. Amit Goffer, who is quadriplegic. Founded in Israel, Argo has gained international attention and extensive media coverage thanks to the ReWalk system, and the company now has headquarters in the U.S. and Germany as well.
The ReWalk personal system, designed for everyday use by patients, has been on the European market since 2012, according to Argo’s website. The exoskeleton has been available in clinics in the U.S., but the new FDA win means patients can own the system themselves.
"Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," FDA Office of Device Evaluation director Christy Foreman said in prepared remarks. "Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."