StoryRegulatory
FDA clears ReWalk 7, the seventh-generation ReWalk personal exoskeleton
Lifeward received FDA 510(k) clearance for ReWalk 7, the seventh generation of its personal exoskeleton for people with spinal cord injury. The clearance builds on the 2023 approval of ReWalk 6.0 for stairs and curbs and the 2024 Medicare payment decision. CEO Larry Jasinski called it a major milestone for the company and the industry.
- 510(k) clearance announced March 13, 2025, for people with spinal cord injury.
- ReWalk was the first exoskeleton the FDA cleared for spinal cord injury, in 2014.
- US sales were set to begin as soon as the product was available (launched April 15, 2025).