FDA cleared Wandercraft's Eve on August 3. The traditional 510(k), K260381, covers a powered exoskeleton (product code PHL) for eligible wheelchair users with spinal cord injury at any level. Use is limited to level indoor surfaces and adjacent outdoor areas such as patios, under supervision of a trained companion. FDA received the file on February 5; the review took 179 days. Wandercraft announced the clearance on August 11.
Eve is the first self-balancing personal exoskeleton: the user walks hands-free, with no crutches, and steers by remote. It follows Atalante X, the company's clinic exoskeleton already cleared in the U.S. A three-site study ran at the James J. Peters VA Medical Center in the Bronx, the Kessler Foundation in New Jersey and Walk in New York. Participants could operate the device and complete daily tasks. They reported gains in endurance, spasticity, sitting balance, sleep, and bladder and bowel function.
Wandercraft was founded in Paris in 2012 and announced a $75M Series D in June 2025. Renault Group took a minority stake alongside Bpifrance's PSIM fund, Teampact Ventures, Quadrant Management and LBO France. U.S. sales start September 17. The company expects Medicare eligibility within 60 to 90 days under HCPCS code K1007. That window matters more than the launch date. The clearance sets the indication; the K1007 fee schedule sets the size of the market.