ReWalk exoskeleton gets FDA approval for home use
Following multiple clinical studies, the Food and Drug Administration (FDA) has cleared the way for the ReWalk to be sold for personal use in the US. This makes the ReWalk the first motorized exoskeleton designed for people with lower body paralysis due to spinal cord injury to be cleared for personal use in the US.
ReWalk consists of a wearable brace support worn outside clothing, a computer-based control system and motion sensors to enable paraplegics to sit, stand, walk and even climb stairs with a little motorized help. Until now, the ReWalk technology has only been available in the US at rehabilitation clinics in the form of the ReWalk Rehabilitation system. This version is designed specifically for use in a clinical rehabilitation environment and as such can be adapted to fit users of different sizes and weights.
The ReWalk Personal System, on the other hand, is customized to suit a specific user and is designed for daily use in a range of environments, including outdoors and on a variety of surfaces and terrains. It was first cleared for personal use in the UK in 2012 and has been available there and throughout Europe since that time. Now those in the US have the chance to take home their own ReWalk with the FDA issuing a marketing clearance for the device.
"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," said Larry Jasinski, CEO of ReWalk Robotics. "For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials."
Potential customers will need to become certified in using the ReWalk system by completing a training program and undergoing a medical examination.