New York, NY – [Date of Article Publication, e.g., August 15, 2024] – In a landmark development set to redefine personal mobility for individuals with spinal cord injuries, Wandercraft, a pioneer in walking robotics, has announced that its revolutionary personal self-balancing exoskeleton, Eve, has received clearance from the U.S. Food and Drug Administration (FDA). This pivotal approval ushers in an era where hands-free upright mobility extends beyond the confines of rehabilitation centers, bringing a new dimension of independence and participation to everyday life for eligible wheelchair users across the United States.
Eve represents a profound leap forward in assistive technology, offering a robust, self-balancing system that allows users to stand, walk, and engage in daily activities with their hands free. For countless individuals whose opportunities for upright movement have historically been limited to clinical settings, Eve opens a world of possibilities, enabling ordinary moments to hold extraordinary meaning – from reaching for a book on a high shelf to enjoying conversations eye-to-eye.
A New Era of Independence: The Journey to FDA Clearance
Wandercraft’s journey began with a clear vision: to empower individuals with mobility challenges through advanced robotics. This ambition first materialized in the form of Atalante X, a sophisticated self-balancing rehabilitation exoskeleton. Atalante X quickly established itself as a cornerstone in neurorehabilitation, deployed in over 150 rehabilitation and research centers worldwide. Its success laid the critical groundwork, providing invaluable data and experience in developing intelligent, dynamically stable walking systems.
The conceptualization of Eve was a natural progression, driven by the desire to bridge the gap between clinical rehabilitation and real-world application. While Atalante X revolutionized gait training within controlled environments, Wandercraft recognized the profound need for a personal device that could seamlessly integrate into the daily lives of users. The challenge was immense: designing an exoskeleton that was not only safe and effective but also intuitive, adaptable, and capable of operating in varied, albeit level, home and community settings.
The path to FDA clearance for a medical device as innovative as Eve is rigorous and demanding. It involves extensive research, development, and testing to demonstrate safety, efficacy, and readiness for widespread use. For Eve, this process culminated in a comprehensive three-site clinical trial conducted at leading 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.
These trials were meticulously designed to assess Eve’s performance across critical parameters, including safety, functional capabilities, the effectiveness of its training protocol, and its overall readiness for personal use outside of a clinical environment. The participant cohort encompassed individuals with a range of spinal cord injury severities, ensuring that the device’s capabilities were evaluated across a broad spectrum of potential users. Each participant underwent structured training, mirroring the comprehensive care pathway designed for future commercial users, before engaging in a series of functional, usability, and task-based assessments specifically tailored to reflect typical everyday activities. The successful completion of these trials, demonstrating Eve’s ability to safely and effectively support upright mobility, was instrumental in securing the FDA’s clearance, marking a monumental milestone for Wandercraft and the entire field of assistive robotics.
The Science Behind the Stand: Supporting Data and Clinical Validation
At the heart of Eve’s groundbreaking capabilities lies its advanced self-balancing technology. Unlike previous generations of exoskeletons that often required crutches or significant upper body support, Eve’s sophisticated algorithms and sensors continuously monitor and adjust the user’s center of gravity, maintaining stability dynamically. This allows for truly hands-free operation, liberating the user’s upper limbs to perform essential tasks such as carrying objects, opening doors, or simply gesturing during conversation. The device is operated via a remote controller, enabling users to initiate movements and manage their upright experience with ease.
The clinical trials provided robust evidence of Eve’s transformative potential. Participants, representing diverse levels of spinal cord injury, successfully completed the structured training program, which consists of five two-hour sessions. This intensive training, which can be completed in as little as one week, covers critical aspects such as safe transfers into and out of the device, proficient remote-controller operation, walking on level surfaces, navigating tight spaces, performing activities of daily living (ADLs) while upright, and understanding safety and emergency procedures.
The results were compelling: participants not only learned to operate Eve effectively but also met key functional and usability endpoints. These included significant improvements in walking performance metrics and the successful completion of various ADLs, underscoring the device’s practical utility in real-world scenarios. Dr. Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation, highlighted the profound relevance 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. The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance."
Beyond objective measures, the clinical program yielded deeply impactful user-reported outcomes. Participants noted improvements in several aspects of their daily lives, including enhanced health status, psychological well-being, and increased endurance during daily activities. Specific physical benefits reported included reductions in lower-limb spasticity and improvements in sitting balance. Remarkably, some users also experienced positive changes in sleep quality and even bladder and bowel function, illustrating the holistic benefits of prolonged upright mobility and physical activity.
These findings are particularly significant when viewed against the backdrop of broader statistics. 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 specifically affected by spinal cord injuries. For this vast population, the ability to stand and move upright is not merely a matter of physical mechanics; it is deeply intertwined with physical health, social interactions, psychological well-being, and overall participation in daily life. Eve’s clinical validation directly addresses these profound needs, offering a pathway to regaining cherished experiences and fostering greater independence.
Voices of Change: Official Responses and Testimonials
The sentiment surrounding Eve’s FDA clearance is one of profound excitement and anticipation, echoed by Wandercraft’s leadership, test pilots, and key researchers. Matthieu Masselin, co-founder and CEO of Wandercraft, articulated the monumental nature 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.” He emphasized the synergistic potential of Wandercraft’s offerings, stating, “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.” Masselin’s words underscore the company’s commitment to creating a seamless transition from clinical recovery to personal autonomy, allowing users to reclaim the simple yet profound activities that define everyday living.
Perhaps the most poignant endorsements come from those who have personally experienced Eve’s transformative power. Caroline Laubach, a Wandercraft Test Pilot, shared her deeply personal 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 testimony vividly illustrates the emotional, social, and practical impact of the device – the ability to engage with the world from a different perspective, to perform tasks independently, and to experience a renewed sense of self-assurance. These are benefits that extend far beyond mere physical movement, touching upon the very essence of human dignity and social connection.
From a scientific and clinical perspective, Dr. Gail Forrest’s assessment provides crucial validation. Her emphasis on evaluating the technology based on its integration into "real-world activities" rather than just "engineering performance" highlights the comprehensive and practical nature of Eve’s development and testing. Her conclusion that the combination of functional performance, usability, and user-reported outcomes gives Eve "substantial clinical relevance" affirms its potential to genuinely improve lives and integrate effectively into existing care paradigms. The collective voice from these key stakeholders paints a compelling picture of a device that is not only technologically advanced but also deeply human-centered in its design and impact.
Paving the Way Home: Implications for Access, Adoption, and the Future
The FDA clearance is just the beginning. Wandercraft is meticulously planning for the commercial launch of Eve in the United States, scheduled 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, which will simultaneously celebrate its 80th anniversary. This livestreamed program is designed to be a comprehensive gathering, bringing together individuals living with spinal cord injuries, their caregivers, clinicians, researchers, policymakers, and current Eve pilots. The event will serve as a powerful platform to celebrate the transition of self-balancing exoskeleton technology from a rehabilitation tool to a truly personal mobility solution, symbolizing a new era of independence. Viewers worldwide will be able to register and watch the livestream on September 17 at 6 p.m. ET via the provided link.
A core tenet of Wandercraft’s mission is a deep "Commitment to Access." The company understands that innovative technology is only as valuable as people’s ability to use it every day. Recognizing the complexities of healthcare reimbursement, Wandercraft has made significant investments to ensure that qualified users can access Eve. This commitment is supported by a crucial development: Medicare has provided a reimbursement pathway for eligible personal exoskeleton users since 2024, under its Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) program, using billing code K1007. Wandercraft anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days following its commercial launch. Beyond Medicare, the company plans to broaden patient access through engagement with private payers and other funding sources, striving to make walking at home a reality for as many qualified users as possible.
To navigate this intricate landscape, Wandercraft has established a dedicated group of access specialists. These experts will work closely with users and their care teams, providing comprehensive assistance with claim submissions, clarifying coverage requirements, addressing reimbursement questions, and exploring available financing options. This holistic support system is designed to minimize barriers and facilitate the adoption of Eve.
The successful integration of Eve into the lives of users relies on a robust ecosystem of support. Before use, individuals must be prescribed Eve by a licensed healthcare practitioner. This is followed by a thorough clinical assessment, an individualized device fitting, and comprehensive training with a specially trained companion. The training curriculum is extensive, covering everything from transfers and remote-controller operation to navigating various environments and understanding safety protocols.
Wandercraft has strategically partnered with a growing network of leading organizations to ensure a seamless process from initial evaluation to "white-glove delivery" directly to the user’s home. This network includes:
- Walk US: With its flagship Walk in New York location and a second planned for Miami, Walk US specializes in neurorehabilitation using Atalante X. It will serve as a critical partner for Eve evaluations, training, demonstrations, community education, and preparation for personal use at home.
- National Seating & Mobility (NSM): As North America’s largest provider of complex rehabilitation technology (CRT), 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 be instrumental in supporting evaluation, access, delivery, and ongoing service for Eve users.
- Good Shepherd Rehabilitation: This esteemed institution will serve as the exclusive Eve partner in Pennsylvania’s Lehigh Valley. Eligible users and their companions will have access to information, demonstrations, and eventually, the technology itself at Good Shepherd’s Hyland Center, with plans for additional access points 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), its VA Medical Centers, and other VA facilities nationwide. This partnership underscores Wandercraft’s commitment to providing advanced technologies to veterans.
Collectively, these organizations are building the essential clinical, reimbursement, distribution, training, and service infrastructure required to translate FDA clearance into tangible, meaningful access for eligible individuals.
Looking ahead, Eve’s FDA clearance represents more than just a product launch; it signifies a paradigm shift in healthcare and robotics. It demonstrates the potential for advanced robotic solutions to move beyond controlled environments and into the personal spaces of those who need them most. The implications for the quality of life, independence, and social participation of individuals with spinal cord injuries are profound. It will undoubtedly inspire further innovation in assistive technology, pushing the boundaries of what is possible in personal mobility.
For those eager to experience this revolutionary technology, a select group of qualified individuals will be invited to participate in a pre-commercial launch program. Interested individuals may request consideration by completing an online inquiry form at Wandercraft.eu/form. As the September 17, 2026, commercial launch approaches, the anticipation continues to build for what promises to be a transformative moment for thousands of lives across the nation.
Learn more at: Wandercraft.eu.
