The U.S. Food and Drug Administration has cleared Eve, a self-balancing personal exoskeleton developed by Wandercraft, for eligible adult wheelchair users living with spinal cord injury. The device is intended for use on level indoor surfaces and adjacent outdoor areas under the supervision of a specially trained companion.
Users operate Eve via a remote control, enabling them to walk and perform certain activities of daily living hands-free. The clearance follows a clinical trial conducted at three sites, including the Kessler Foundation's Tim and Caroline Reynolds Center for Spinal Stimulation.
The trial demonstrated that participants and their companions could learn to operate the device and met key functional and usability endpoints, including measures of walking performance and activities of daily living.
Participants reported improvements in daily life, including health status, psychological well-being, endurance during daily activities, lower-limb spasticity, and sitting balance. Some participants also reported improvements in sleep quality and bladder and bowel function.
Gail Forrest, Ph.D., director of the Kessler Foundation center, noted that the evaluation assessed not only engineering performance but also how users and companions could safely integrate the technology into real-world activities.
The device represents a new category of mobility assistance that provides hands-free walking capability for a population that typically relies on wheelchairs for all mobility.
Eve's clearance is limited to specific eligible users who can operate the remote control and requires a trained companion for supervision during use.
Further real-world data will help define the device's long-term role in rehabilitation and daily living for people with spinal cord injury.
FDA approves first self-balancing, personal exoskeleton
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