Wednesday, September 17, 2014

Bionic Suit cleared by FDA for home use

The below article by Bionics Research is a major step forward for individuals with spinal chord injuries.  It is also important for people living with a progressive neuro-muscular disorder like Kennedy's Disease.  The more of these units the hit the market, the lower the cost.  It also allows for even greater testing and generates interest in the for similar units that will support other uses.

ReWalk™ Bionic Suit

Personal Exoskeleton System Cleared by FDA for Home Use

Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S.

Marlborough, MA—June 26, 2014 — Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

The FDA has issued a marketing clearance for the ReWalk, which was granted via a rigorous de novo process that involved multiple clinical studies demonstrating safety and effectiveness of the technology.