FDA Clears Exoskeleton for Spinal Cord Injury - Summary - MDSpire
Coming Soon: Introducing MDSpire News. Learn more
Conexiant’s news site is now MDSpire News. Learn more

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

  • 2 min

Share

Objective:

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

Approach:
  • 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.
Key Findings:
  • 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.
Limitations:
  • The study did not specify the exact number of participants or the severity of their spinal cord injuries.
Conclusion:

Wandercraft plans to make Eve commercially available in the US on September 17, 2026.

Sources:

Original Source(s)

FDA Clears Exoskeleton for Spinal Cord Injury

  • by Kathryn Wighton

  • August 12, 2026

Related Content

Side Effects: The Body Keeps Score

Turns out biology tracks more than we thought — from a spit test that reads your all-nighter to a surgical outcome that still shows up in household chores two decades later. Plus: habits aren't built gradually. They snap.

Treatable Pediatric Neuromuscular Disorders

Through a case-based, evidence-driven approach, this Neuroscience Grand Rounds session highlights how clinicians can differentiate among neuromuscular conditions, localize disease processes and identify those disorders where timely treatment can significantly alter disease trajectory.

  • June 19, 2026

  • 1 min
A Case Study and Literature Review on Type IV Spinal Muscular Atrophy with Gastrocnemius Pseudohypertrophy Due to SMN1 Gene Deletion