FDA OKs Wandercraft’s Next-Gen Eve Self-Balancing Exoskeleton

Wandercraft has obtained U.S. Food and Drug Administration (FDA) approval for Eve, a self-balancing exoskeleton designed to support upright mobility. FDA clearance was supported by a three-site clinical trial involving participants with spinal cord injuries and their companions.

Eve, which will be launched in the U.S. on September 17, enables eligible adults with spinal cord injuries to walk and perform hands-free daily activities using self-balancing technology. The device is intended for use on level indoor surfaces and adjacent open-air areas under the supervision of a trained companion.

The New York, N.Y.-based company’s technology is designed to complement (not replace) a wheelchair by expanding patients’ opportunities to stand, walk, bend, turn, use their hands, and participate in everyday activities while upright. It received

Eve requires a prescription, clinical assessment, individualized fitting, and companion training. Training consists of five two-hour sessions covering device operation, transfers, walking, maneuvering, activities of daily living, and safety procedures.

It supports a care pathway that includes clinical assessment, individualized fitting, structured training, reimbursement assistance, and long-term support. Medicare has offered a reimbursement pathway for eligible personal exoskeleton users since 2024 through the DMEPOS program under billing code K1007.

Wandercraft believes Eve could become eligible for Medicare reimbursement within 60 to 90 days. The company said it has plans to broaden patient access via private payers and other funding sources.

The company’s flagship Atalante X exoskeleton earned FDA clearance for SCI patients with injury from levels C4 to L5 and in those with multiple sclerosis in November.

Comments from Wandercraft and users

Co-Founder/CEO Matthieu Masselin: “FDA clearance of Eve marks one of the most important moments in Wandercraft’s history and a significant step for the people, families, clinicians, researchers, and partners who helped make it possible. Together, Atalante X and Eve may offer eligible users a pathway from walking during rehabilitation to upright mobility at home, whether making coffee at the kitchen counter, reaching for a book, or spending time with friends on the patio.

Caroline Laubach, Wandercraft Test Pilot: “For years, I experienced much of the world while seated. Using Eve transformed ordinary moments in ways I never expected, like having conversations eye-to-eye whether seated or standing, getting a cup from the highest kitchen cabinet, and simply bringing a new type of confidence into my life.