The US Food and Drug Administration cleared Eve, a self-balancing personal exoskeleton that allows eligible wheelchair users with spinal cord injury to walk without using their hands and perform certain activities of daily living, according to a press release from Kessler Foundation.
The US Food and Drug Administration based its clearance on a clinical trial conducted at Kessler Foundation, the James J. Peters Department of Veterans Affairs Medical Center in the Bronx, and Wandercraft’s Walk in New York center, that included patients with spinal cord injury and their companions. Investigators examined device safety and function as well as training and preparedness for personal use.
Eve uses self-balancing technology and is intended for eligible adults with spinal cord injury who can operate its remote control. The device is designed for use on level surfaces indoors and in nearby outdoor areas with oversight from a companion who has received specialized training.
Patients with varying spinal cord injury severity completed structured training followed by assessments of function, usability, and specific tasks that reflected the device’s intended use in daily settings. Participants and their companions were able to learn how to use Eve and perform activities associated with personal use of the device, according to Kessler Foundation.
Study endpoints assessing function and usability were met, including those related to walking and activities of daily living. Participants described better health status, psychological well-being, daily activity endurance, lower-limb spasticity, and sitting balance. A subset of participants reported better sleep quality as well as improvements in bladder and bowel function.
“The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance,” said Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation.
According to National Spinal Cord Injury Statistical Center data cited in the release, the estimated US population living with traumatic spinal cord injury is 308,620, with approximately 18,400 new cases annually.
Wandercraft plans to make Eve commercially available in the US on September 17, 2026.
Source: Kessler Foundation
