NEW YORK, Nov. 03, 2025 (GLOBE NEWSWIRE) — Wandercraft, global leader in self-balancing exoskeletons and humanoids, announced that the U.S. Food and Drug Administration (FDA) has cleared expanded indications and upgraded features for its flagship rehabilitation device, Atalante X.This clearance comes just a few short months after receiving expanded CE Mark certification for enhanced clinical features and a wider range of neurologic conditions, such as tetraplegia and tetraparesis.
The extension of indication authorizes use in individuals 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 advancement in rehabilitation builds upon earlier FDA indications for SCI at levels T5-L5 and for individuals with hemiplegia due to cerebrovascular accidents (CVA).
“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.”
Atalante X is in over 100 rehabilitation and research centers worldwide enabling thousands of patients to take over 1 million steps per month, with recent deployments in Moody Neurorehabilitation Institute and Rancho Research Institute.
Findings from a multicenter retrospective study of 547 training sessions among patients with high-level spinal cord injury, supported the FDA’s decision, confirming the safe use of Atalante X among this patient population in rehabilitation and suggest potential functional benefits in tetraplegic patients. Clinical results were presented at this year’s annual meeting of the American Academy of Physical Medicine and Rehabilitation (AAPM&R) in Salt Lake City, October 22-25.
“We now have data confirming what we had observed in practice, that Atalante X can be used safety and effectively by people with high-level spinal cord injuries and Multiple Sclerosis,” said Maria Ida Iacono, Global Chief Regulatory, Quality and Clinical Affairs Officer of Wandercraft. “Participants showed encouraging functional improvements, with a solid safety profile and high levels of user satisfaction.”
Now Available: Even More Customized Rehabilitation for Complex Patients
Traditional exoskeletons require users to bear weight with crutches or walkers, excluding those with limited upper-limb or trunk control. Atalante X’s self-balancing design removes that limitation, allowing clinicians to initiate upright training even with severely impaired patients.
The upgraded system now also offers joint-specific assistance control – independent tuning at each hip and knee motor – and step-length adjustments in 5 percent increments, enabling fine, progressive adaptation to each patient’s motor profile. These capabilities give therapists greater precision to align every session with clinical objectives, comfort, and safety.
The update to the Atalante X system also includes:
- Enhanced graphical data in patient reports now display assistance values below zero (i.e., resistive), providing clinicians with a more complete view for improved clinical tracking
- Updated training protocols for clinician onboarding
- Refined hardware components, including more durable foam support
Clinical Need
Spinal cord injury (SCI) affects an estimated 296,000 people in the United States¹ and more than 20.6 million worldwide², with roughly 45 percent resulting in some degree of tetraplegia¹. Each year, an additional 17,900 new SCI cases¹ occur in the U.S., most leading to lifelong paralysis and secondary health complications such as muscle atrophy, bone loss, and cardiovascular issues.
Multiple sclerosis (MS) affects nearly 1 million people in the U.S.³ and 2.8–2.9 million worldwide⁴, often leading to progressive mobility impairment. For both populations, maintaining upright posture and ambulation – even briefly – can improve cardiovascular health, bone density, and psychological well-being. Yet traditional rehabilitation options remain limited once upper-limb function or trunk control is compromised.
Cerebrovascular accident (CVA / stroke) is another leading cause of long-term disability, affecting nearly 795,000 Americans each year⁵ and more than 12 million people globally⁶. Approximately half of stroke survivors experience hemiplegia or significant gait impairment, often requiring long-term therapy to restore independence.
Atalante X can address these critical needs by enabling hands-free, self-balancing ambulation powered by AI, enabling clinicians to safely retrain gait and posture in patients who are unable to support themselves with crutches or walkers.
“Atalante X restores the possibility of upright movement for patients once thought to be too impaired to walk again. We’re building technology that brings humanity back into rehabilitation,” added Masselin. “This extension of indication also further validates Wandercraft’s unstoppable momentum as a force in the global medical device market, today in rehab and next year at home.”
- https://msktc.org/sites/default/files/Facts-and-Figures-2024-Eng-508.pdf
- https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(23)00287-9/fulltext
- https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence
- https://www.msif.org/resource/atlas-of-ms-2020/
- https://www.cdc.gov/stroke/data-research/facts-stats/index.html
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11786524/
About Wandercraft
Wandercraft is a global robotics company on a mission to restore mobility and expand what’s possible through self-balancing systems that leverage AI. Known for the viral Personal Exoskeleton, Eve, Wandercraft is developing the next generation of mobility solutions to restore walking ability both at home and in rehabilitation. Its flagship device, the Atalante X, is the worlds-first self-balancing exoskeleton used at more than 100 inpatient and outpatient rehabilitation centers.
In 2025, Wandercraft expanded into industrial robotics with the launch of Calvin-40, a strong, voice-controlled humanoid robot developed through a strategic partnership with Renault Group. Built on the same life-tested robotics platform as Wandercraft’s medical exoskeletons, Calvin is engineered to perform physically demanding or hazardous tasks in real-world environments, starting with automotive manufacturing. With more than 30 patents and a deeply human mission, Wandercraft believes that everyone should have the chance to move freely – and that robotics should connect with people where they are, with reliability, responsiveness, and purpose. Learn more at wandercraft.eu.
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3c819814-4e25-44f0-a9b8-99044fc695a5