Safety
The FDA sent a warning letter to ReWalk's maker for not running a follow-up safety study it had ordered after clearance. The FDA said a failure to prevent a fall could seriously injure or kill the user.
A crash, recall, injury or investigation
What the source says
“failure to prevent a fall would be reasonably likely to cause serious user injury and/or death”
What it means
Medical exoskeletons, from Lifeward (ReWalk), Wandercraft, Ekso Bionics (owned by Wandercraft since Oct 2026), is at stage 5 of 5 on our ladder: regulator-cleared or mass market. Safety events don't move a stage on their own, but they stay on the robot's record.
Human help: A staff member rides along, ready to stop it.
More on Medical exoskeletons
- Wandercraft bought Ekso Bionics from ChronoScale and said it would keep supporting Atalante X, EksoNR, Eve and Indego Personal. The price was not disclosed.
- Wandercraft said the FDA cleared Eve, a self-balancing exoskeleton for personal use, for adults with spinal cord injuries at any level, used with a trained companion.
- Ekso's parent company, renamed ChronoScale and moving into cloud computing, said it would sell the Ekso exoskeleton business.
- The FDA cleared the ReWalk 7 Personal Exoskeleton from Lifeward (510(k) K241822) for indoor and outdoor walking, including stairs and curbs.
- Medicare set a payment rate for personal exoskeletons for home use, starting with the ReWalk Personal and the Indego Personal.
- Ekso Bionics bought the Indego exoskeleton business from Parker Hannifin for $10 million.