Lifeward Ltd. announced on March 13, 2025, that it has received 510(k) FDA clearance for the ReWalk 7, the newest generation of its personal exoskeleton device. This clearance is a major milestone for the company and the industry, enabling commercialization in the United States.
The ReWalk 7 is a wearable exoskeleton designed to allow individuals with spinal cord injury (SCI) to stand and walk again. This seventh generation device includes a number of new features, enhancements, and upgrades aimed at improving user experience and functionality.
Lifeward plans to begin sales of the ReWalk 7 in the United States as soon as the product becomes available. This regulatory approval builds on previous advancements, including the FDA clearance of ReWalk 6.0 for stairs and curbs in 2023, and the national Medicare reimbursement policy established in 2024.
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