FDA approves first self-balancing, personal exoskeleton
The U.S. Food and Drug Administration has cleared Eve (Wandercraft), the first self-balancing personal exoskeleton for eligible adult wheelchair users living with spinal cord injury.
The U.S. Food and Drug Administration recently approved Eve, the first self-balancing personal exoskeleton, for use by eligible adult wheelchair users with spinal cord injuries. Designed to be operated remotely, Eve enables users to walk and perform daily activities hands-free on level indoor surfaces and nearby outdoor areas under the supervision of a specially trained companion.
A clinical trial conducted at three sites demonstrated that both users and companions could learn to use Eve effectively, achieving important functional and usability goals such as improved walking performance, daily living activities, lower-limb function, and spasticity. Participants also reported positive changes in their health status, psychological well-being, endurance, balance, sleep quality, and bladder/bowel function following Eve use.
The FDA's approval of Eve is significant because it was evaluated not only on its technical performance but also on how users and companions could safely incorporate it into everyday activities. Gail Forrest, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at the Kessler Foundation, emphasized the importance of these findings in real-world settings.
Written by urgent.news from Medical Xpress's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
