Lifeward has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ReWalk 7, the newest generation of its personal exoskeleton device.

ReWalk is a wearable exoskeleton that lets people with spinal cord injury (SCI) stand and walk again. The seventh generation of ReWalk includes new features, enhancements, and upgrades.

This clearance comes in the wake of other major developments for Lifeward—in 2023, the FDA cleared the ReWalk 6.0 for use on stairs and curbs. Last year, the Centers for Medicare & Medicaid Services (CMS) issued a national reimbursement policy for all beneficiaries that qualify for using the device.

Lifeward made history in 2014 when it earned the nation’s first FDA clearance for an exoskeleton medical device for patients with SCI.

“FDA clearance is a major milestone for our company and for the industry,” said Larry Jasinski, CEO of Lifeward. “For two decades, Lifeward has been committed to providing our users with the most advanced exoskeleton technology and expanding access to all those who can benefit from use of the device. With the ReWalk 7, we are able to deliver on that commitment, and will continue to look for opportunities to innovate and improve upon medical devices for the SCI community.”

Last month, Lifeward announced that CEO Larry Jasinski will step down after 13 years of leading the company. He will continue to serve in his roles through Q2 2025 to help with a transition to a successor.