Core Insights - Lifeward Ltd. has received 510(k) FDA clearance for its latest personal exoskeleton device, the ReWalk 7, which is designed for individuals with spinal cord injury (SCI) [1][2] - The ReWalk 7 features new enhancements and upgrades, continuing Lifeward's commitment to providing advanced exoskeleton technology [2] - The company plans to begin sales of the ReWalk 7 in the United States as soon as it becomes available [3] Company Developments - Lifeward has a history of innovation, having previously received FDA clearance for the ReWalk 6.0 in 2023, which allowed use on stairs and curbs, and a national reimbursement policy from CMS in 2024 for eligible beneficiaries [2] - The company was the first to receive FDA clearance for an exoskeleton medical device for individuals with SCI in 2014 [2] - Lifeward's mission is to drive innovation in medical technology to improve the lives of individuals with physical limitations or disabilities [3] Product Portfolio - Lifeward's product offerings include the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, all aimed at enhancing rehabilitation and recovery [3]
FDA Issues Clearance for ReWalk 7 Exoskeleton