French robotics company Wandercraft has received clearance from the US Food and Drug Administration (FDA) for Eve, a personal self-balancing exoskeleton designed to support upright mobility in wheelchair users living with spinal cord injuries.
For many wheelchair users, opportunities to stand and move upright have traditionally been limited to rehabilitation settings. Building on the company’s experience with Atalante X, a self-balancing rehabilitation exoskeleton, Eve is designed to extend upright mobility beyond the clinic.
Eve enables eligible adults with spinal cord injuries at any level who can operate the device’s remote control to walk and perform daily activities 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.
Wandercraft said that Eve is designed to complement, rather than replace, the wheelchair by expanding opportunities to stand, walk, bend, turn, use their hands and participate in everyday activities while upright.
“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,” he added.
The FDA clearance was supported by a three-site clinical trial involving participants with spinal cord injuries and their companions. The study was led by the James J. Peters Department of Veterans Affairs Medical Center in the Bronx, New York; Kessler Foundation in West Orange, New Jersey; and Walk in New York in New York City.
Participants reported improvements in several aspects of daily life, including health status, psychological well-being, endurance during daily activities, lower-limb spasticity and sitting balance. Some participants also reported improvements in sleep quality and bladder and bowel function.
Wandercraft plans to commercially launch Eve in the United States on September 17, 2026. Ahead of the commercial launch, a select group of qualified individuals will be invited to experience the device, the company said.
Eve will be prescribed by licensed healthcare practitioners. Before using the device, individuals must undergo a clinical assessment, personalised device fitting and comprehensive training with a companion.
The training consists of five two-hour sessions, which can be completed in as little as one week. It covers transfers, remote-controller operation, walking on level surfaces, navigating tight spaces, activities of daily living, and safety and emergency procedures.
