ReWalk Earns FDA Clearance for Exoskeleton to Climb Stairs and Curbs
ReWalk Robotics Ltd., which provides technologies to enable mobility and wellness in rehabilitation scenarios, has announced that its ReWalk Personal Exoskeleton technology earned clearance from the U.S. Food and Drug Administration (FDA) for use on stairs and curbs in the U.S. ReWalk said the clearance makes it the only personal exoskeleton to receive FDA clearance, with designation of the device as a “Breakthrough Device” for its ability to provide ambulatory access to environments containing stairs and curbs for paralyzed individuals with spinal cord injury (SCI).
The advancement combines the mechanical design of the exoskeleton with its proprietary stair climbing software to enable users with access to several everyday environments, allowing them to participate in more walking activities in their daily lives. ReWalk said this feature has been available in Europe since initial CE clearance, and real-world data from 47 European users over a period of seven years with more than 18,000 steps collected showed the safety and efficacy of the feature to support the FDA submission.
“Our mission at ReWalk has been to achieve widespread access to the health benefits of walking in everyday life for individuals with spinal cord injury,” said Larry Jasinski, CEO of ReWalk. “Today’s announcement demonstrates our commitment from a technical perspective to improve access to a broader range of activities of daily living, such as walking up the steps to visit a friend’s home, or stepping over a curb during a neighborhood walk. In parallel, our focus continues to be to broaden access to these life-changing technologies through expanding payor coverage as we continue to work with Medicare to develop the pathway to reimbursement for medically eligible individuals.”
“To have the option to sit, stand, walk and even step over curbs as a paralyzed individual is unimaginably rewarding,” said Simon Kindleysides, a ReWalk user and Guinness World Record holder for the most stairs climbed in an exoskeleton. “I’m in full control of the exoskeleton, and I am able to conquer stairs and other obstacles that may appear in my way. It’s been life-changing for me.”
ReWalk said it looks forward to expanding the possibilities for its users in the U.S. with the FDA clearance. For more details on the company and its technologies, visit the ReWalk website here.