On June 26 FDA allowed the marketing of Argo Medical Technologies’s ReWalk, the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury.

The device is worn over the legs and part of the upper body to help an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aid, FDA said in a news release.

The agency said the CDC estimates there are about 200,000 people in the United States living with a spinal cord injury, many of whom have complete or partial paraplegia. The release quoted CDRH Office of Device Evaluation director Christy Foreman as saying that with ReWalk, physical therapy, training, and help from a caregiver, these people may be able to walk again in their homes and in their communities.

ReWalk consists of a fitted metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising from a chair. Using a wireless remote control worn on the wrist, the user commands the ReWalk to stand up, sit down, or walk.

To assess safety and effectiveness of ReWalk, FDA reviewed testing done to assess the device’s durability, hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power. The agency says it also reviewed clinical data based on 30 study participants.

—Jim Dickinson is MD+DI's contributing editor.