For the first time, the U.S. Food and Drug Administration has cleared a self-balancing personal exoskeleton that lets adults with spinal cord injuries walk hands-free — a milestone that could change daily life for millions of wheelchair users.
The device is called Eve, made by a company called Wandercraft. Unlike older exoskeletons that require walkers or crutches to stay upright, Eve balances on its own. Users operate it with a simple remote control.
The approval came after a trial at three clinical sites, where participants and their companions learned to use the device and met goals for walking performance and everyday tasks. Dr. Gail Forrest, who directs the Tim and Caroline Reynolds Center for Spinal Stimulation at the Kessler Foundation — one of the trial locations — said what made the study stand out was that researchers looked at both technical performance and real-world usability.
"The technology was evaluated not only on engineering performance but also on how users and companions could safely integrate it into real-world activities," Forrest said.
Beyond walking, users reported feeling better in unexpected ways. Participants said their overall health improved, their mood lifted, they had more stamina during the day, and some noticed better sleep, less muscle stiffness in their legs, and even improvements in bladder and bowel function. Sitting balance also got better for many.
Eve is intended for use on flat indoor floors and nearby outdoor areas, and users must have a specially trained companion with them while using it.
For people who have spent years or decades in wheelchairs, the ability to stand, walk to the kitchen, or simply face a friend at eye level can be profound. This approval marks the first time such technology has passed through the FDA's review for personal use — a door that, once opened, may keep swinging wider as the technology gets smaller, lighter, and more accessible.