Robotic exoskeletons are attracting growing interest in clinical neurorehabilitation, with new approvals boosting expectations for broader patient access. Wandercraft’s Atalante X, designed for individuals with severe mobility limitations, represents a notable product in this field. Following recent U.S. Food and Drug Administration (FDA) clearance, the company can now target a wider range of neurological conditions, including spinal cord injury and multiple sclerosis. Previous initiatives focused primarily on lower-level injuries, but this expansion opens possibilities for addressing more complex cases. The process leading up to this FDA clearance included not only regulatory hurdles but also validation through multicenter research efforts and clinical partnerships.
Wandercraft’s earlier advancements were largely recognized in Europe, where the Atalante X had gained CE Mark certification, signaling compliance with strict safety requirements. Earlier clinical trials focused on hemiplegia and stroke recovery, which showcased its utility for a narrower subset of patients. Recent reports now highlight a shift to higher-level injuries and multiple sclerosis, moving beyond the device’s previously limited applications. The timeline demonstrates steady, incremental progress in expanding reach and capabilities rather than rapid or radical shifts.
What does expanded FDA clearance mean for Atalante X?
The expanded FDA clearance allows Wandercraft to market Atalante X for rehabilitation of individuals with spinal cord injury from C4 to L5, as well as those with multiple sclerosis. This increases access to hands-free gait therapy, letting more patients regain upright mobility. The Atalante X was previously cleared for patients with lower-level spinal cord injuries and post-stroke hemiplegia, but the latest authorization builds on these foundations to address a broader spectrum of conditions.
How was Atalante X’s expanded use verified?
Clinical validation was achieved through a multicenter study involving 547 therapy sessions. Data from multiple rehabilitation sites supported the safe use of Atalante X among individuals with complicated mobility challenges. According to Maria Ida Iacono, Global Chief Regulatory, Quality and Clinical Affairs Officer at Wandercraft,
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.
The study’s findings indicated positive functional changes and a favorable safety profile for this patient group.
How do new features impact therapies and patients?
Recent upgrades to Atalante X include joint-specific assistance at each hip and knee, refined step-length adjustments, and improved data visualization for clinicians. The self-balancing exoskeleton enables upright movement, even in individuals with severe upper body impairment. Wandercraft’s CEO, Matthieu Masselin, commented,
This extension of indication for Atalante X marks a significant advance in neurorehabilitation and patient access to technology that enables them to walk again.
Additional enhancements—such as more durable hardware and updated training protocols—further refine the user and clinician experience.
With over 100 rehabilitation centers worldwide using Atalante X, Wandercraft’s technology continues to support thousands of patients each month. The need is substantial, with millions affected by spinal cord injuries and multiple sclerosis globally. Access to upright, hands-free gait therapy holds potential benefits for cardiovascular health, bone density, and psychological well-being, complementing the growing recognition of mobility as a factor in long-term recovery.
Development in robotic exoskeletons like Atalante X highlights frequent intersections between regulatory navigation, ongoing research, and evolving clinical needs. Emerging evidence points to exoskeleton-assisted rehabilitation providing additional therapeutic options, although comprehensive head-to-head trials and long-term data remain limited. For clinicians and patients, understanding device capabilities and eligibility criteria is critical to maximize efficacy. Additionally, evaluating insurance coverage, user training protocols, and potential integration into broader care plans should be priorities for adoption. Regulators and researchers will likely track these devices’ real-world outcomes as their indications expand. Those considering robotic rehabilitation may benefit from comparing multiple products, clinical studies, and reported user experiences to make informed choices.
- FDA expands Atalante X’s use to more neurological conditions.
- Clinical research backs the device’s safety and effectiveness.
- Upgrades enhance therapy options for those with severe mobility limits.
