Wandercraft’s Exoskeleton Gets FDA OK for Wider Use in Rehab

• Wandercraft’s Atalante X is now cleared for spinal cord injuries from C4 to L5 and multiple sclerosis.
• The FDA clearance allows more patients with severe mobility loss to access self-balancing, upright gait therapy.

Wandercraft has received expanded FDA clearance for its Atalante X exoskeleton, now approved for people with spinal cord injuries from levels C4 to L5 and for those with multiple sclerosis. It’s the second indication extension in less than two years, building on earlier approvals for lower-level SCI and stroke-related hemiplegia. The update opens access to upright gait therapy for patients with more severe upper-body impairments.

“This extension of indication for Atalante X marks a significant advance in neurorehabilitation and patient access to technology that enables them to walk again,” said Matthieu Masselin, CEO of Wandercraft, in a press release. “It enables therapists to personalize training for complex patients, now going as far as to the joint level, and help even more people with severely limited upper-body strength to experience upright movement safely and confidently – something which many thought was impossible.” 

The updated Atalante X lets clinicians adjust support at each hip and knee joint, fine-tune step length, and track both assistive and resistive effort in patient reports. Its self-balancing design removes the need for crutches or walkers, allowing upright movement even for patients without upper-limb or trunk control. Other upgrades include revised training protocols for clinicians and more durable foam supports.

A multicenter study of 547 training sessions in patients with high-level spinal cord injuries confirmed that Atalante X can be used safely in clinical settings. The findings showed consistent user satisfaction and signs of functional improvement, which supported the FDA’s expanded clearance. The exoskeleton is now in use at more than 100 rehabilitation and research centers worldwide, including Moody Neurorehabilitation and Rancho Research Institute. The company says the device has enabled "thousands of patients to take over 1 million steps per month."

🌀 Tom’s Take:

When a machine helps people walk, the impact is human, not just technical. FDA clearance means more lives can be changed, not just more devices deployed.

Source: GlobeNewswire / Wandercraft