NEW YORK, NY – [Date of Publication] – In a landmark development set to redefine personal mobility, Wandercraft, a leading innovator in robotics, has announced that its self-balancing personal exoskeleton, Eve, has received clearance from the U.S. Food and Drug Administration (FDA). This pivotal clearance paves the way for eligible wheelchair users to experience hands-free upright mobility not just in rehabilitation settings, but in the comfort and familiarity of their own homes and immediate surroundings, marking a significant leap forward in assistive technology.
Eve is designed to empower adults with spinal cord injuries at any level, enabling them to stand, walk, and perform daily activities with unparalleled independence. Its sophisticated self-balancing technology eliminates the need for crutches or walking frames, freeing users’ hands to interact with their environment in ways previously unimaginable outside of clinical supervision. This clearance signals a new era, moving advanced robotic assistance from specialized centers directly into the daily lives of individuals, offering opportunities for interaction and participation that hold profound personal meaning.
Main Facts: A New Horizon for Personal Mobility
The FDA clearance for Eve is more than just a regulatory approval; it represents a paradigm shift in how individuals with mobility impairments can engage with the world. For years, the ability to stand and move upright for many wheelchair users has been largely confined to structured rehabilitation environments. Wandercraft’s Eve shatters these limitations, extending the benefits of upright mobility into the fabric of everyday life.
At its core, Eve is a personal self-balancing exoskeleton, meticulously engineered to support upright mobility. It enables eligible adults with spinal cord injuries, who can operate its intuitive remote control, to walk and execute activities of daily living hands-free. The device is specifically intended for use on level indoor surfaces and adjacent open-air areas like patios and terraces, always under the supervision of a specially trained companion. Crucially, Eve is envisioned as a complementary tool, working in concert with wheelchairs rather than replacing them. Its purpose is to broaden opportunities – allowing users to stand, walk, bend, turn, and use their hands while upright, thereby participating more fully in their daily routines.
Matthieu Masselin, co-founder and CEO of Wandercraft, articulated the monumental impact of this achievement: “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. Together, Atalante X and Eve may offer eligible users a pathway from walking during rehabilitation to upright mobility at home, whether making coffee at the kitchen counter, reaching for a book, or spending time with friends on the patio.” His statement underscores the company’s vision of a seamless transition from clinical progress to domestic independence.
Chronology: From Rehabilitation Pioneer to Home Companion
Wandercraft’s journey to developing Eve is rooted in a deep commitment to transforming mobility through advanced robotics. The company first gained international recognition for its rehabilitation exoskeleton, Atalante X. This groundbreaking device, celebrated for its dynamic self-balancing capabilities, has been deployed in over 150 rehabilitation and research centers worldwide. Atalante X provided invaluable clinical experience, data, and technological refinements that laid the essential groundwork for Eve. It demonstrated the feasibility and efficacy of self-balancing technology in assisting gait and upright posture in a controlled environment.
The transition from a clinical rehabilitation device like Atalante X to a personal, at-home exoskeleton presented unique engineering and design challenges. While Atalante X focused on intensive therapy, Eve needed to be lighter, more user-friendly, and capable of navigating the varied, less-controlled environments of a home. Wandercraft’s engineers focused on optimizing the self-balancing algorithms, enhancing the intuitive remote control, and ensuring the device was robust yet comfortable for prolonged daily use. The development process involved iterative design, rigorous testing, and extensive user feedback, all aimed at creating a device that was not only technologically advanced but also truly practical and safe for personal use.
The pathway to FDA clearance for Eve was a demanding and meticulous process. It required comprehensive clinical trials to demonstrate the device’s safety, effectiveness, and usability in real-world scenarios. These trials were instrumental in proving that individuals and their companions could be adequately trained to operate Eve safely and effectively outside of a dedicated clinical setting. The clearance signifies that Eve meets the stringent standards set by the FDA for medical devices intended for personal use, a testament to Wandercraft’s unwavering dedication to scientific rigor and patient safety.
Supporting Data: Clinical Validation and Life-Altering Impact
The significance of Eve’s clearance is firmly anchored in robust clinical evidence and compelling user experiences. According to the Christopher & Dana Reeve Foundation, over five million people in the United States live with some form of paralysis, with hundreds of thousands affected by spinal cord injuries. For this vast population, the ability to stand and move upright is not merely a functional goal; it is a deeply meaningful experience that profoundly impacts physical health, social interactions, and overall participation in daily life.
FDA clearance for Eve was supported by a pivotal three-site clinical trial conducted at esteemed institutions: the James J. Peters Department of Veterans Affairs Medical Center in the Bronx, NY; Kessler Foundation in West Orange, NJ; and Walk in New York in New York City, NY. This multi-center approach ensured a diverse participant pool and comprehensive evaluation across different clinical environments. The trial specifically focused on evaluating the device’s safety, functional performance, the effectiveness of its training protocol, and its readiness for personal use.
Participants in the trial represented a wide spectrum of injury severities, ensuring that the findings would be broadly applicable. Each participant underwent structured training, after which they completed a series of functional, usability, and task-based assessments. These assessments were carefully designed to mirror the types of activities and environments encountered in everyday life, providing a realistic measure of Eve’s capabilities.
The results were overwhelmingly positive. The clinical program definitively demonstrated that both participants and their companions could effectively learn to operate Eve and safely complete activities relevant to personal use. Crucially, participants met key functional and usability endpoints, including significant improvements in measures of walking performance and the ability to perform activities of daily living (ADLs). This objective data underscores Eve’s capacity to deliver tangible, measurable benefits to users.
Beyond objective metrics, the subjective experiences reported by participants were equally compelling. Many reported marked improvements in several aspects of their daily lives, including enhanced health status, improved psychological well-being, increased endurance during daily activities, a reduction in lower-limb spasticity, and better sitting balance. Some even noted positive impacts on sleep quality and improvements in bladder and bowel function – often overlooked but profoundly important aspects of quality of life for individuals with spinal cord injuries.
Caroline Laubach, a Wandercraft Test Pilot, shared a powerful personal testimony: “For years, I experienced much of the world while seated. Using Eve transformed ordinary moments in ways I never expected, like having conversations eye-to-eye whether seated or standing, getting a cup from the highest kitchen cabinet, and simply bringing a new type of confidence into my life.” Her words vividly illustrate the emotional and practical liberation that Eve can offer.
Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation, emphasized the comprehensive nature of the evaluation: “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.” Her statement highlights that Eve’s success is not just about robotic prowess, but its profound impact on human lives.
Official Responses: A United Vision for Access and Empowerment
The leadership at Wandercraft, along with its clinical and distribution partners, has articulated a clear and unified vision for Eve: to make advanced self-balancing mobility accessible to all eligible individuals. This vision extends beyond mere technological innovation, encompassing a comprehensive approach to patient access, support, and integration into daily life.
Matthieu Masselin’s initial remarks set the tone, emphasizing the collaborative effort behind Eve’s success. His vision of a "pathway" from rehabilitation with Atalante X to home independence with Eve highlights a progressive care model. This integrated approach suggests that individuals can build foundational strength and skills in a clinical setting, then transition to personal use, maintaining and expanding their mobility in their home environments. This continuity of care is crucial for sustained well-being and independence.
The profound impact on individuals is eloquently captured by test pilot Caroline Laubach. Her experience underscores the often-underestimated psychological benefits of upright mobility – the confidence derived from eye-level conversations, the simple dignity of reaching for an item on a shelf, and the overall sense of empowerment. These are not merely functional gains but deeply personal victories that contribute significantly to mental health and social inclusion.
Dr. Gail Forrest’s expert opinion validates the clinical rigor and real-world applicability of Eve. Her emphasis on evaluating how users and companions could "safely integrate it into real-world activities" rather than just engineering performance, speaks to a holistic understanding of patient needs. This approach ensures that Eve is not just a high-tech gadget, but a practical, safe, and truly beneficial medical device for daily use. The "substantial clinical relevance" she attributes to Eve’s outcomes reinforces its potential to become a standard of care for personal mobility assistance.
Beyond these individual statements, Wandercraft’s broader commitment to access is evident in its strategic partnerships and proactive approach to reimbursement. The company understands that even the most revolutionary technology is only as good as people’s ability to use it every day. This commitment is a core tenet of their operational philosophy, driving efforts to dismantle financial and logistical barriers.
Implications: Revolutionizing Healthcare, Expanding Access, and Shaping the Future
Eve’s FDA clearance has far-reaching implications, not only for the individuals it serves but also for the broader landscape of healthcare and robotics. It represents a significant evolution in both fields, bringing sophisticated self-balancing technology beyond controlled rehabilitation settings into the personal sphere. This transition is supported by a meticulously designed care pathway that includes clinical assessment, individualized device fitting, structured training, reimbursement assistance, and long-term support, ensuring a holistic user experience.
Commitment to Access and Reimbursement:
Wandercraft is making substantial investments to ensure that Eve is accessible to qualified users. This includes leveraging existing reimbursement mechanisms. Medicare has already established a reimbursement pathway for eligible personal exoskeleton users since 2024, under its Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) program, utilizing billing code K1007. Wandercraft anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days following its commercial launch. Furthermore, the company has strategic plans to broaden patient access through private payers and other funding sources, aiming to make at-home walking a reality for a wider population. To navigate the complexities of healthcare financing, Wandercraft has established a dedicated group of access specialists. These experts will work directly with users and their care teams, assisting with claim submissions, clarifying coverage requirements, addressing reimbursement questions, and exploring available financing options, thereby reducing the burden on individuals and families.
Commercial Availability and Launch:
The commercial launch of Eve in the United States is strategically planned for September 17, 2026. This momentous occasion will be marked by an exclusive unveiling event at the Cure healthcare innovation campus in New York City. Presented in collaboration with the United Spinal Association, as the organization celebrates its 80th anniversary, the livestreamed program promises to be a landmark gathering. It will bring together people living with spinal cord injuries, their caregivers, clinicians, researchers, policymakers, and pioneering Eve pilots to commemorate the transition of self-balancing exoskeleton technology from clinical rehabilitation to personal, at-home use. Viewers globally can register to watch the livestream on September 17 at 6 p.m. ET.
Prescription and Training Pathway:
Access to Eve will be carefully managed to ensure optimal safety and efficacy. The device will be prescribed by licensed healthcare practitioners. Before an individual can begin using Eve, they must complete a comprehensive clinical assessment, undergo an individualized device fitting, and participate in thorough training alongside a companion. This training program is intensive yet efficient, comprising five two-hour sessions that can be completed in as little as one week. The curriculum covers essential skills such as safe transfers, proficient remote-controller operation, walking on various level surfaces, navigating tight spaces, performing activities of daily living while upright, and critical safety and emergency procedures.
Taking Eve Home: A Robust Partner Network:
Before its full commercial launch, a select group of qualified individuals will be invited to experience Eve through an exclusive early access program, allowing them to provide valuable feedback and become pioneers in this new era of mobility. Interested individuals can apply through an online inquiry form on Wandercraft’s website. Following the commercial launch, Wandercraft has forged strategic partnerships with a growing network of rehabilitation centers, complex rehabilitation technology (CRT) providers, and federal distribution partners. This network, alongside Wandercraft’s existing "walk centers" worldwide, is designed to ensure a seamless process from initial evaluation to white-glove delivery directly to the user’s home.
Key partners in this expansive network include:
- Walk US: With its flagship "Walk in New York" location, Walk US specializes in neurorehabilitation utilizing Atalante X. It will serve as a crucial partner for Eve evaluations, training, demonstrations, community education, and preparing users for personal use at home. A second location, "Walk in Miami by Wandercraft," is slated to open later in the year, expanding regional access.
- National Seating & Mobility (NSM): As North America’s largest provider of complex rehabilitation technology, NSM has been named Wandercraft’s exclusive CRT distribution partner for Eve. Leveraging its extensive network of over 180 locations across the United States and Canada, NSM will play a vital role in supporting evaluation, facilitating access, managing delivery, and providing ongoing service for Eve users.
- Good Shepherd Rehabilitation: This organization will serve as the exclusive Eve partner in Pennsylvania’s Lehigh Valley. Eligible users and their companions will have the opportunity to learn about and experience the technology at Good Shepherd’s Hyland Center, with plans for additional access locations in the future.
- USVetServ: A Service-Disabled Veteran-Owned Small Business, USVetServ will act as an authorized independent distributor of both Eve and Atalante X for the U.S. Department of Veterans Affairs (VA), including its VA Medical Centers and other facilities nationwide. This partnership underscores Wandercraft’s deep commitment to ensuring that veterans have access to the most advanced assistive technologies.
Collectively, these organizations are building the essential clinical, reimbursement, distribution, training, and service infrastructure necessary to translate FDA clearance into meaningful, widespread access for eligible users across the nation.
Broader Societal Impact and Future Outlook:
The introduction of Eve promises a profound broader societal impact. It moves beyond simply aiding physical movement, touching upon psychological well-being, social inclusion, and the very definition of independence. By enabling individuals to stand eye-to-eye with others, engage in activities that were once out of reach, and navigate their personal spaces with newfound freedom, Eve can significantly enhance quality of life. It fosters greater participation in family life, community activities, and potentially, even professional endeavors.
Wandercraft’s vision extends beyond this initial launch. The company is committed to continuous innovation, exploring ways to further enhance Eve’s capabilities, expand its indications, and broaden its global reach. This FDA clearance is not an endpoint but a powerful catalyst, propelling Wandercraft and the entire field of assistive robotics into a future where advanced technology seamlessly empowers human potential, making the extraordinary achievable in everyday moments.
For more information, visit Wandercraft.eu.
Featured image: Woman using Wandercraft Eve self-balancing personal exoskeleton to stand. Photo: Wandercraft
