Wandercraft, a company specializing in self-balancing exoskeletons and humanoids, has gained U.S. Food and Drug Administration (FDA) clearance for expanded indications and upgraded features for its flagship Atalante X rehabilitation device.

The indication extension allows use in people with spinal cord injury (SCI) from levels C4 to L5 and in those with multiple sclerosis (MS), broadening access to upright, hands-free gait therapy. This builds on earlier FDA indications for SCI at levels T5-L5 and for people with hemiplegia due to cerebrovascular accidents (CVA).

The upgraded system features joint-specific assistance control with independent tuning at each hip and knee motor. It also has step-length adjustments in 5% increments for fine, progressive adaptation to each patient’s motor profile.

Enhanced graphical data in patient reports now show assistance values below zero, offering a more complete view for clinical tracking. There are also updated training protocols for clinician onboarding and refined hardware components, including more durable foam support.

Atalante X is in more than 100 rehab and research centers around the world, enabling patients to take over a million steps per month, Wandercraft said. It had recent deployments in Moody Neurorehabilitation Institute and Rancho Research Institute.

Data from a retrospective study of 547 training sessions among patients with high-level SCI supported the FDA nod, confirming safe use of Atalante X in this patient population in rehab and suggesting potential functional benefits in tetraplegic patients.

Traditional exoskeletons make users bear weight with crutches or walkers, excluding patients with limited upper limb or trunk control. Atalante X’s self-balancing design removes that limitation, letting clinicians begin upright training even with severely impaired patients.

“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. “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.”