Lifeward (Nasdaq:LFWD) announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk 7.
ReWalk 7, the seventh generation of the exoskeleton platform made by Lifeward (formerly ReWalk Robotics), allows individuals with spinal cord injury (SCI) to stand and walk again. This version includes a number of new features, enhancements and upgrades, according to a news release.
Lifeward plans to begin sales for ReWalk 7 in the U.S. “as soon as the product is available,” the company said.
The latest milestone follows a series of positive steps for Lifeward following its 2024 rebrand to “Lifeward” to expand its portfolio. Larry Jasinski, CEO of Lifeward spoke to MassDevice last year about the benefits of the rebrand.
Last year, the company hit milestones, including a national reimbursement policy from CMS, which followed 2023 clearance for the ReWalk 6.0 system for use on stairs and curbs.
“FDA clearance is a major milestone for our company and for the industry,” said Jasinski, who is retiring later this year. “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 the 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.”
