Wandercraft announced today that it received FDA clearance for its Atalante X exoskeleton for individuals with spinal cord injuries (SCIs).
The FDA granted clearance for people with SCIs at levels T5 to L5 to utilize the self-balancing robotic exoskeleton technology. The system enables those with limited mobility to stand up and walk again.
Wandercraft says safety and efficacy data from more than 500 patients supported the regulatory nod. Atalante X already picked up FDA clearance for cerebrovascular accident in December 2022.
Wandercraft’s Atalante X exoskeleton features a powered ankle mechanism. It can perform complex ankle movements that enable wearers to mimic a natural human gait. This helps therapists better assist patients in their rehabilitation, the company said.
Therapists can help users stand up and walk in the exoskeleton, including in their very first session. The wearer can take steps in different directions and practice standing up in an upright, weight-bearing position. Wandercraft said users can also more easily transfer in and out of the device.
The company unveiled its Personal Exoskeleton, a self-balancing system for personal everyday use, in December 2023. Both Atalante X and the Personal Exoskeleton represent the company’s goal to help patients with limited mobility through their rehab journey.
“Today’s FDA clearance for individuals with spinal cord injuries speaks volumes about the amazing possibilities for Atalante X, as we seek to help as many patients as possible to stand and walk again,” Wandercraft CEO Matthieu Masselin said. “Wandercraft has achieved several key milestones over the last year including two FDA clearances, on top of the successful unveiling of our personal exoskeleton. I am proud of the hard work of the entire Wandercraft team, as we push forward with the ultimate vision of Atalante X- to support people with limited mobility through every step of their journey.”
Wearable robotics and exoskeletons are currently having their moment in the sun, it seems. Companies like Myomo and Lifeward (formerly ReWalk Robotics) are set to benefit from major Medicare changes around these devices. Lifeward CEO Larry Jasinski recently spoke to MassDevice about the future for the technology.