Wandercraft Receives FDA Clearance for Self-Balancing Personal Exoskeleton

NEW YORK—The United States Food and Drug Administration (FDA) has granted clearance to Wandercraft for Eve, its personal self-balancing exoskeleton designed to support upright mobility in everyday life.

For eligible wheelchair users, the clearance brings hands-free upright mobility into ordinary moments that may hold extraordinary meaning.

The concept of Eve builds on experience with Atalante X, Wandercraft’s self-balancing rehabilitation exoskeleton used in more than 150 rehabilitation and research centers worldwide.

Eve enables eligible adults with spinal cord injuries at any level who can operate Eve’s remote to walk and perform activities of daily living hands-free, using self-balancing technology. The device is intended for use on level indoor surfaces and level surfaces in immediately adjacent open-air areas that are part of a building, such as patios and terraces, under the supervision of a specially trained companion.

Eve will be prescribed by licensed healthcare practitioners. Before use, individuals must complete a clinical assessment, an individualized device fitting and training with a companion. Training includes five two-hour sessions that can be completed in as little as one week and covers transfers, remote-controller operation, walking on level surfaces, navigating tight spaces, activities of daily living and safety and emergency procedures.

“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,” said Matthieu Masselin, co-founder and CEO of Wandercraft. “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.”

Wandercraft said it anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days, with plans to broaden patient access via private payers and other funding sources.  

Wandercraft plans to commercially launch Eve in the United States on September 17.

Eve will be officially unveiled at an exclusive event at the Cure healthcare innovation campus in New York City, presented with the United Spinal Association as the organization celebrates its 80th anniversary. The company said the livestreamed program will bring together people living with spinal cord injuries, caregivers, clinicians, researchers, policymakers and Eve pilots to mark the transition of self-balancing exoskeleton technology from rehabilitation to personal use.

Viewers can register to watch the livestream here: share.hsforms.com/2iWRkru7sTcmpTGdO6_Lo1Q5aapy