Wandercraft has secured US Food and Drug Administration (FDA) clearance for its self-balancing standing exoskeleton, supporting upright mobility for wheelchair users with spinal cord injuries.
Paris-based Wandercraft highlighted that its exoskeleton, named Eve, builds on its experience with Atalante X, a rehabilitation exoskeleton used in over 150 rehabilitation and research centres worldwide. The FDA clearance for Eve means this device’s offering extends beyond the clinic.
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According to the Christopher & Dana Reeve Foundation, more than five million people in the US live with paralysis, including hundreds of thousands with spinal cord injuries.
Designed to complement, rather than replace, the wheelchair by expanding opportunities to stand, Wandercraft’s Eve uses advanced motorised joints and stabilisation algorithms that automatically manage balancing dictates required for upright movement. Meanwhile, patients use a handheld controller to guide their directional movement.
Eve’s FDA clearance was supported by findings from a three-site clinical trial involving participants with spinal cord injuries. Focusing on safety, function, training, and readiness for personal use, trial patients with a range of injury severities completed structured training before undergoing functional, usability, and task-based assessments with Eve that were designed to reflect the upright exoskeleton’s intended use in everyday environments.
By the end of the trial, participants reported improvements in several aspects of daily life, including health status, psychological well-being, endurance during daily activities, lower-limb spasticity, and sitting balance, Wandercraft stated, with some also reporting improvements in sleep quality and bladder and bowel function.
Gail Forrest, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation, which acted as one of the three clinical trial sites for Eve, commented: “What makes these findings meaningful is that the technology was evaluated not only on engineering performance but also on how users and companions could safely integrate it into real-world activities.
“The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance,” Forrest added.
With regulatory tenets for Eve supported by a $75m Series D financing round Wandercraft completed in June 2025, the company now intends to launch Eve in the US in September 2026.
Wandercraft highlighted that Medicare has provided a reimbursement pathway for eligible personal exoskeleton users since 2024 as part of its Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) programme under billing code K1007.
In preparation for Eve’s upcoming market launch, Wandercraft has partnered with a range of rehabilitation and complex rehabilitation technology (CRT) providers including New York-based Walk US and Pennsylvania’s Good Shepherd Rehabilitation to boost commercial awareness of the exoskeleton.
Wandercraft’s CEO, Matthieu Masselin, commented: “FDA clearance of Eve marks one of the most important moments in Wandercraft’s history and a significant step for the people, families, clinicians, researchers, and partners who helped make it possible.”
Other device companies in the exoskeleton space include ReWalk. The Massachusetts-based company’s first exoskeleton received FDA clearance in 2014, with the latest generation, ReWalk 7, securing clearance from the agency in March 2025.
