The FDA has cleared the ReWalk Personal Exoskeleton technology with specialized software for use on stairs and curbs.
ReWalk Robotics, a technology provider that enables mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, announced that its ReWalk Personal Exoskeleton technology had received clearance from the Food and Drug Administration (FDA) for use on stairs and curbs.
According to ReWalk, it is the first personal exoskeleton to receive FDA clearance for this indication.
The clearance follows the FDA’s designation of the device as a “Breakthrough Device” in recognition of its ability to provide ambulatory access to environments containing stairs and curbs for paralyzed individuals with spinal cord injury.
The advancement combines the mechanical design of the ReWalk Exoskeleton with the company’s stair-climbing software to give users access to a wide array of everyday environments, allowing them to participate in more walking activities in their daily lives and more opportunities to experience the health benefits of walking.
The feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users over seven years, consisting of over 18,000 stair steps, was collected to demonstrate the safety and efficacy of this feature and 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, chief executive officer 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.”
ReWalk looks forward to expanding the possibilities for its users in the United States with this recent FDA clearance.
Photo via ReWalk Robotics