Wandercraft gets FDA clearance for Eve, a self-balancing exoskeleton for wheelchair users with spinal cord injuries

Wandercraft/Eve

The FDA cleared Eve, Wandercraft's self-balancing personal exoskeleton, for eligible adults with spinal cord injuries at any neurological level, the company announced on August 11, 2026. The clearance followed a clinical trial at three sites in New York and New Jersey, where the company says participants met key functional and usability endpoints.

• Eligible users need a prescription, a clinical assessment, an individual fitting and five two-hour training sessions with a companion.
• Intended use is on level indoor floors and nearby open-air areas such as patios, under a trained companion's supervision.
• Wandercraft expects Medicare reimbursement eligibility within 60 to 90 days; Medicare covers qualifying personal exoskeletons under HCPCS code K1007.
• The company said the US commercial launch was planned for September 17, 2026, with a wider fall rollout through distribution partners.