FDA Clears Exoskeleton for Spinal Cord Injury

Use is limited to level indoor and adjoining outdoor areas and requires supervision by a companion with specialized training.

To report on the FDA clearance of the Eve exoskeleton for eligible wheelchair users with spinal cord injury.

Clinical Trial: The FDA clearance was based on a clinical trial conducted at Kessler Foundation, the James J. Peters Department of Veterans Affairs Medical Center, and Wandercraft’s Walk in New York center, which included patients with spinal cord injury and their companions.
Device Functionality: Investigators examined the device's safety, function, and user training for personal use.
Training and Assessment: Patients underwent structured training followed by assessments of function, usability, and specific tasks related to daily use.

Participants learned to use Eve and perform activities associated with personal use.
Study endpoints related to walking and activities of daily living were met.
Participants reported improved health status, psychological well-being, daily activity endurance, lower-limb spasticity, and sitting balance.
Some participants noted better sleep quality and improvements in bladder and bowel function.