NEW YORK, NY – [Date, e.g., August 15, 2024] – In a monumental stride for assistive technology and a profound leap towards enhanced independence for individuals with mobility challenges, Wandercraft, a pioneer in robotics, today announced that its personal self-balancing exoskeleton, Eve, has received clearance from the U.S. Food and Drug Administration (FDA). This landmark approval positions Eve to redefine upright mobility, enabling eligible wheelchair users to experience hands-free standing and walking in their everyday lives, moving beyond the confines of rehabilitation centers and into the sanctity of their homes and communities.
Eve represents a transformative innovation designed specifically to support upright mobility. For countless individuals who rely on wheelchairs, opportunities to stand and move vertically have historically been limited to highly controlled clinical environments. With its advanced self-balancing technology, Eve promises to unlock a new dimension of freedom and participation, allowing users to engage in ordinary moments that often hold extraordinary personal meaning – from sharing eye-level conversations with loved ones to performing daily tasks with newfound autonomy.
The FDA clearance for Eve is not merely a regulatory milestone; it signals a paradigm shift in the availability of sophisticated robotic assistance for personal use. The device is intended for eligible adults with spinal cord injuries (SCI) at any level, empowering them to walk and perform activities of daily living hands-free, guided by a remote controller and under the supervision of a specially trained companion. Its design prioritizes safety and utility on level indoor surfaces and immediately adjacent open-air areas, such as patios and terraces, integrating seamlessly into a user’s home environment. Wandercraft emphasizes that Eve is designed to complement, rather than replace, the wheelchair, offering an expanded spectrum of mobility options that include standing, walking, bending, turning, and engaging hands-free in a myriad of daily activities while upright.
This significant development is set to culminate in a highly anticipated commercial launch in the United States on September 17, 2026. The official unveiling will take place at an exclusive event at the Cure healthcare innovation campus in New York City, co-hosted with the United Spinal Association, which will be celebrating its 80th anniversary. The livestreamed program is expected to draw a diverse audience, including individuals living with spinal cord injuries, caregivers, clinicians, researchers, policymakers, and Eve pilots, all eager to witness this pivotal moment in the transition of self-balancing exoskeleton technology from rehabilitation to widespread personal use.
A Journey of Innovation: From Clinic to Home
Wandercraft’s journey to the development of Eve is rooted in a deep commitment to advancing human mobility through robotics. The company first made its mark with Atalante X, a sophisticated self-balancing rehabilitation exoskeleton. Atalante X has been instrumental in numerous rehabilitation and research centers worldwide, currently deployed in over 150 facilities, where it has helped countless patients regain strength, improve gait, and experience the benefits of upright movement in a therapeutic setting. This extensive clinical experience provided Wandercraft with invaluable insights and a robust technological foundation upon which to build Eve.
The conceptualization of Eve stemmed from the understanding that while rehabilitation exoskeletons were highly effective in clinics, the true aspiration for many users was to extend that newfound mobility into their daily lives. The challenge was to adapt the complex self-balancing technology, which allows for hands-free operation and natural movement patterns, for safe and practical personal use outside of controlled clinical environments. This required a meticulous design process, rigorous testing, and an unwavering focus on user experience and safety.
The path to FDA clearance for Eve involved a comprehensive and multi-faceted clinical trial program. This critical phase was designed to demonstrate not only the safety and efficacy of the device but also its usability and readiness for personal integration into users’ homes. Collaborating with leading rehabilitation institutions, Wandercraft gathered extensive data on how individuals with spinal cord injuries and their trained companions could effectively operate Eve, perform daily tasks, and integrate upright mobility into their routines. The successful completion of these trials, proving Eve’s ability to facilitate functional movements and enhance quality of life, paved the way for the FDA’s clearance, marking a culmination of years of dedicated research, engineering, and clinical validation.
Comprehensive Supporting Data Validates Eve’s Transformative Potential
The FDA clearance for Eve is underpinned by compelling clinical evidence derived from a robust three-site clinical trial. This trial rigorously evaluated the device’s safety, function, training efficacy, and overall readiness for personal use, involving participants with a diverse range of spinal cord injury severities. The participating institutions included 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.
Participants underwent structured training protocols before engaging in a series of functional, usability, and task-based assessments. These assessments were meticulously designed to mirror real-world scenarios, ensuring that the technology’s performance was evaluated in contexts relevant to everyday environments. The findings were highly encouraging: the clinical program unequivocally demonstrated that both participants and their trained companions could proficiently learn to operate Eve and successfully complete activities critical for personal use. Crucially, participants met key functional and usability endpoints, showcasing significant improvements in walking performance and the ability to execute activities of daily living while upright.
Dr. Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation, underscored the profound significance of these findings. "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," Dr. Forrest stated. "The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance." The studies conducted at James J. Peters VA Medical Center further contributed to Eve’s progress, highlighting how Wandercraft’s technology has evolved to meet the practical needs of people with spinal cord injuries and bring state-of-the-art robotics closer to personal use in everyday settings.
Beyond objective functional improvements, the clinical trials also captured invaluable subjective feedback from participants, revealing a broad spectrum of enhancements to their daily lives. Users reported significant improvements across various dimensions, including their overall health status, psychological well-being, and endurance during daily activities. Specific physical benefits noted included a reduction in lower-limb spasticity and improved sitting balance. Furthermore, some participants experienced positive impacts on sleep quality and even improvements in bladder and bowel function – often overlooked but critical aspects of quality of life for individuals with spinal cord injuries.
The societal need for such advanced assistive devices is underscored by statistics from the Christopher & Dana Reeve Foundation, which estimates that over five million people in the United States live with paralysis, with hundreds of thousands specifically affected by spinal cord injuries. For this substantial population, the ability to stand and move upright transcends mere physical function; it represents a deeply meaningful experience that positively impacts physical health, fosters richer social interactions, and enables greater participation in the fabric of daily life. Eve’s clearance directly addresses this profound need, offering a pathway to reclaim aspects of life previously limited by mobility constraints.
Official Responses and Commitment to Accessibility
The official response from Wandercraft’s leadership reflects both immense pride and a clear vision for the future. Matthieu Masselin, co-founder and CEO of Wandercraft, articulated the monumental significance 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," Masselin commented. He further emphasized the synergistic relationship between Wandercraft’s existing rehabilitation exoskeleton and Eve: "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 words paint a vivid picture of the expanded possibilities Eve presents, transforming mundane tasks into acts of reclaimed independence.
The personal impact of Eve is perhaps best captured by the experiences of those who have already piloted the device. Caroline Laubach, a Wandercraft Test Pilot, shared her transformative journey: "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 testimonial powerfully illustrates the profound psychological and social benefits that extend beyond mere physical capability, touching upon dignity, confidence, and enhanced social engagement.
This clearance also signifies a crucial evolution in the broader landscape of healthcare and robotics. Eve’s self-balancing technology, previously confined to controlled rehabilitation settings, is now poised for integration into personal home environments. This expansion is supported by a meticulously designed care pathway that includes rigorous clinical assessment, individualized device fitting, comprehensive structured training, dedicated reimbursement assistance, and long-term support for users. Wandercraft’s holistic approach ensures that the technology is not only available but also accessible and sustainable for those who need it most.
A cornerstone of Wandercraft’s strategy is its unwavering "Commitment to Access." Recognizing that technological innovation is only truly valuable if people can readily use it, the company has made substantial investments to facilitate access for qualified users. A critical development in this regard was the Medicare provision of 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’s dedicated team of access specialists will work closely with users and their care teams to navigate complex claim submissions, clarify coverage requirements, address reimbursement queries, and explore available financing options. The company anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days following its commercial launch, with strategic plans already in motion to broaden patient access through private payers and other funding sources, ultimately making walking at home a reality for many more qualified individuals.
Profound Implications for Independence and Healthcare
The introduction of Wandercraft’s Eve carries profound implications across multiple dimensions, promising to reshape the lives of individuals with spinal cord injuries and influence the broader healthcare landscape.
Impact on Users’ Lives: Reclaiming Independence and Dignity
For eligible users, Eve offers more than just physical mobility; it offers a profound return to independence and dignity. The ability to stand eye-to-eye, to reach for objects on high shelves, or simply to move about a home hands-free can dramatically improve quality of life. It fosters greater participation in family activities, reduces reliance on caregivers for certain tasks, and enhances psychological well-being through increased autonomy and self-confidence. The documented improvements in physical health, such as reduced spasticity and improved balance, coupled with potential benefits for sleep, bladder, and bowel function, underscore the holistic positive impact Eve can have on a user’s health. This verticality also opens up new social dimensions, enabling more natural interactions and reducing the physical barriers that often exist in seated positions.
Transforming the Healthcare Landscape: A Shift to Home-Centric Care
Eve’s FDA clearance signals a significant evolution in the delivery of advanced neurorehabilitation and assistive technology. It represents a pivot from predominantly clinic-centric solutions to enabling sophisticated robotic assistance in the home environment. This shift could lead to a broader acceptance and integration of high-tech exoskeletons within the Durable Medical Equipment (DME) framework, paving the way for future innovations to reach users directly. The comprehensive care pathway – encompassing clinical assessment, individualized fitting, and rigorous training for both the user and a companion – highlights a responsible and integrated approach to deploying advanced robotics in a personal setting. This model could become a benchmark for future personal medical devices.
Economic and Social Benefits
While the immediate focus is on individual benefit, the broader economic implications are also significant. Increased independence can potentially reduce the long-term costs associated with extensive personal care and secondary health complications often linked to prolonged sitting. Furthermore, enhanced mobility and participation can open avenues for increased social engagement, vocational opportunities, and overall community integration, contributing positively to society. The establishment of clear reimbursement pathways, particularly through Medicare, is crucial for making this technology financially viable for a wider population.
Strategic Partnerships and Distribution Network
Wandercraft has meticulously built a robust ecosystem of strategic partners to ensure seamless access, training, and support for Eve users. This network is designed to translate the FDA clearance into meaningful, real-world accessibility:
- Walk US: As a key partner, Walk US, with its flagship Walk in New York location and an upcoming Walk in Miami by Wandercraft, specializes in neurorehabilitation using Atalante X. It will play a vital role in Eve evaluations, training, demonstrations, community education, and preparing users for personal home use.
- National Seating & Mobility (NSM): NSM, North America’s largest provider of complex rehabilitation technology (CRT), 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 be instrumental in supporting evaluation, access, delivery, and ongoing service.
- Good Shepherd Rehabilitation: This institution will serve as the exclusive Eve partner in Pennsylvania’s Lehigh Valley, offering eligible users and their companions opportunities to learn about and experience the technology at Good Shepherd’s Hyland Center, with future expansion planned.
- USVetServ: As 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) and its facilities nationwide. This partnership underscores Wandercraft’s commitment to ensuring that veterans, who often face unique mobility challenges, have access to the most advanced assistive technologies.
Collectively, these organizations form the backbone of the clinical, reimbursement, distribution, training, and service infrastructure necessary to transform FDA clearance into a tangible reality for eligible users across the nation.
The Road Ahead: Commercial Launch and Future Horizons
The commercial launch on September 17, 2026, will be a landmark event. Prior to this date, a select group of qualified individuals will be invited to experience Eve, providing early insights and feedback. Interested individuals can request consideration by completing an online inquiry form at Wandercraft.eu/form. Following the full commercial launch, Wandercraft’s network of partners will ensure a smooth process from initial evaluation to white-glove delivery directly to users’ homes.
Eve will be prescribed by licensed healthcare practitioners. The mandatory pre-use protocol includes a clinical assessment, an individualized device fitting, and comprehensive training for both the user and their companion. This intensive training, comprising five two-hour sessions that can be completed in as little as one week, covers essential skills such as transfers, remote-controller operation, walking on level surfaces, navigating tight spaces, performing activities of daily living, and critical safety and emergency procedures.
Wandercraft’s Eve is poised to revolutionize personal mobility, offering a beacon of hope and a tangible pathway to greater independence for countless individuals with spinal cord injuries. By bringing self-balancing exoskeleton technology out of the clinic and into the home, Wandercraft is not just selling a device; it is offering a new perspective on life, standing tall and hands-free.
For more information and to register for the livestreamed launch event on September 17, 2026, at 6 p.m. ET, please visit: https://share.hsforms.com/2iWRkru7sTcmpTGdO6_Lo1Q5aapy.
Learn more about Wandercraft and its innovations at: Wandercraft.eu.
