This milestone follows significant developments including the 2023 FDA clearance of ReWalk 6.0 for stairs and curbs usage, and the 2024 Centers for Medicare & Medicaid Services (CMS) national reimbursement policy approval for qualified beneficiaries. The company, which made history in 2014 with the first FDA-cleared exoskeleton medical device for SCI patients, will commence ReWalk 7 sales in the United States once the product becomes available.
The decision reinforces the medical necessity of ReWalk’s technology and is expected to influence coverage decisions by commercial insurers. The ReWalk 7, the company’s latest innovation and the only personal exoskeleton capable of navigating stairs and curbs, received FDA clearance in March 2025 and is now commercially available in the United States.
Insights
Medicare ruling establishes ReWalk exoskeleton as medically necessary, opening significant reimbursement pathways that should accelerate adoption and revenue growth.
The Administrative Law Judge ruling represents a landmark reimbursement victory for Lifeward’s ReWalk technology. This decision—coming at the highest level of Medicare appeals—establishes legal precedent that the exoskeleton meets Medicare’s critical “reasonable and necessary” standard for medical devices.