FDA clears Eve, a self-balancing exoskeleton for wheelchair users

A wheelchair user with a spinal cord injury can now use a device designed to keep itself upright while walking. The FDA has cleared Eve, Wandercraft’s self-balancing personal exoskeleton, for eligible adults who can operate its remote control.

The system is built for controlled, ordinary spaces rather than every kind of terrain. Eve is intended for level indoor surfaces and adjacent outdoor areas, with use supervised by a specially trained companion. It enables eligible users to walk and perform certain activities of daily living hands-free.

The evidence came from a trial at three clinical sites. Participants and companions learned to operate the device and met key functional and usability endpoints, including measures of walking performance and daily activities. Gail Forrest of the Kessler Foundation said the evaluation examined not only engineering performance but also whether users and companions could integrate the technology safely into real-world activities.

Participants reported improvements in health status, psychological well-being, endurance during daily activities, lower-limb spasticity and sitting balance. Some also reported better sleep quality and bladder and bowel function. Those reports describe benefits observed by participants; the source does not attach the same improvements to every user.

So, concretely, Eve could give eligible wheelchair users a way to stand, walk and handle some daily tasks without using their hands, while keeping a trained companion nearby. The clearance could mark a step into regulated clinical use, but the device’s eligibility criteria, supervision requirement and limited operating surfaces remain part of the everyday reality.