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.
By
Kathryn Wighton
August 12, 2026
Clinical Scorecard: FDA Clears Exoskeleton for Spinal Cord Injury
At a Glance
Category Detail
Condition Spinal Cord Injury Key Mechanisms Self-balancing technology for mobility assistance Target Population Eligible adults with spinal cord injury who can operate the device Care Setting Clinical trial and personal use with trained companions
Key Highlights
Eve allows wheelchair users with spinal cord injury to walk without using hands Device cleared based on clinical trial assessing safety and function Participants reported improvements in health status and psychological well-being Training enabled users to perform daily living activities Commercial availability planned for September 17, 2026 Guideline-Based Recommendations
Diagnosis
Management
Monitoring & Follow-up
Risks
Patient & Prescribing Data
Individuals with spinal cord injury, approximately 308,620 in the US
Device training and oversight by a trained companion are essential for use
Clinical Best Practices
Structured training for device operation Assessment of function and usability in daily settings Monitoring user-reported outcomes for health and well-being Related Resources & Content
