NEW YORK, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Wandercraft announced today that the U.S. Food and Drug Administration (FDA) has granted clearance for Eve™, its personal self-balancing exoskeleton designed to support upright mobility in everyday life.
For eligible wheelchair users, the clearance opens new possibilities beyond rehabilitation, bringing hands-free upright mobility into ordinary moments that may hold extraordinary meaning.
For many wheelchair users, opportunities to stand and move upright have largely been limited to rehabilitation settings. Building on experience with Atalante X™, Wandercraft’s self-balancing rehabilitation exoskeleton used in more than 150 rehabilitation and research centers worldwide, Eve extends upright mobility beyond the clinic.
Eve enables eligible adults with spinal cord injuries at any level who can operate Eve’s remote to walk and perform activities of daily living hands-free, using self-balancing technology. The device is intended for use on level indoor surfaces and level surfaces in immediately adjacent open-air areas that are part of a building, such as patios and terraces, under the supervision of a specially trained companion.
Eve is designed to complement, not replace, the wheelchair by expanding opportunities to stand, walk, bend, turn, use their hands, and participate in everyday activities while upright.
“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,” said Matthieu Masselin, co-founder and CEO of Wandercraft. “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.”
“For years, I experienced much of the world while seated,” said Caroline Laubach, Wandercraft Test Pilot. “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.”
This clearance also marks an important evolution in healthcare and robotics. Eve brings self-balancing technology beyond controlled rehabilitation settings, supported by a care pathway that includes clinical assessment, individualized fitting, structured training, reimbursement assistance, and long-term support.
Commitment to Access
Medicare has provided a reimbursement pathway for eligible personal exoskeleton users since 2024 as part of its Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) program under billing code K1007.
Wandercraft believes technology and innovation are only as good as people's ability to use them every day. Because of this, the company has made significant investments within and outside of the organization to make access a reality for qualified users.
Wandercraft’s dedicated group of access specialists will work with users and their care teams to navigate claim submissions, understand coverage requirements, address reimbursement questions, and explore available financing options.
Wandercraft anticipates that Eve could become eligible for Medicare reimbursement within 60 to 90 days, with plans to broaden patient access via private payers and other funding sources to make walking at home a reality for qualified users ready to take Eve home.
Commercial Availability
Wandercraft plans to commercially launch Eve in the United States on Sept. 17, 2026.
Eve will be officially unveiled at an exclusive event at the Cure healthcare innovation campus in New York City, presented with the United Spinal Association as the organization celebrates its 80th anniversary. The livestreamed program will bring together people living with spinal cord injuries, caregivers, clinicians, researchers, policymakers, and Eve pilots to mark the transition of self-balancing exoskeleton technology from rehabilitation to personal use.
Viewers can register to watch the livestream on Sept. 17 at 6 p.m. ET here: https://share.hsforms.com/2iWRkru7sTcmpTGdO6_Lo1Q5aapy
Eve will be prescribed by licensed healthcare practitioners. Before use, individuals must complete a clinical assessment, an individualized device fitting, and comprehensive training with a companion. Training includes five two-hour sessions that can be completed in as little as one week and covers transfers, remote-controller operation, walking on level surfaces, navigating tight spaces, activities of daily living, and safety and emergency procedures.
Taking Eve Home
Before the commercial launch, a select group of qualified individuals will be invited to experience Eve before it becomes widely available this fall.
Interested individuals may request consideration by completing an online inquiry form at: https://www.wandercraft.eu/form
Following full commercial launch, Wandercraft has partnered with a growing network of rehabilitation, complex rehabilitation technology (CRT) providers, and federal distribution partners, in addition to its walk centers worldwide, to ensure a smooth process from initial evaluation to white-glove delivery directly to their door.
Partners enabling this pathway include:
Walk US, including its flagship Walk in New York location, specializes in neurorehabilitation using Atalante X and will serve as a key partner for Eve evaluations, training, demonstrations, community education, and preparation for personal use at home. A second location, Walk in Miami by Wandercraft, is expected to open later this year.
National Seating & Mobility, North America’s largest provider of complex rehabilitation technology, will serve as Wandercraft’s exclusive CRT distribution partner for Eve, leveraging its network of more than 180 locations across the United States and Canada to support evaluation, access, delivery, and service.
Good Shepherd Rehabilitation will serve as the exclusive Eve partner in Pennsylvania’s Lehigh Valley. Eligible users and their companions will be able to learn more about and eventually experience the technology at Good Shepherd’s Hyland Center, with additional access locations expected to open in the future.
USVetServ, a Service-Disabled Veteran-Owned Small Business, will serve as an authorized independent distributor of Eve and Atalante X for the U.S. Department of Veterans Affairs (VA), its VA Medical Centers, and other VA facilities nationwide as part of Wandercraft’s commitment to helping veterans access the most advanced technologies.
Together, these organizations will build the clinical, reimbursement, distribution, training, and service infrastructure needed to translate FDA clearance into meaningful access for eligible users.
Clinical Evidence and Readiness for Personal Use
According to the Christopher & Dana Reeve Foundation, more than five million people in the United States live with paralysis, including hundreds of thousands with spinal cord injuries. For many, standing and moving upright are deeply meaningful experiences that affect physical health, social interactions, and participation in daily life.
FDA clearance was supported by a three-site clinical trial involving participants with spinal cord injuries and their companions, led by 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.
The clinical trial focused on safety, function, training, and readiness for personal use. Participants represented a range of injury severities and completed structured training before undergoing functional, usability, and task-based assessments designed to reflect intended use in everyday environments.
The clinical program demonstrated that participants and companions could learn to operate Eve and complete activities relevant to personal use. Participants also met key functional and usability endpoints, including measures of walking performance and activities of daily living.
“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,” said Gail Forrest, PhD, director of the Tim and Caroline Reynolds Center for Spinal Stimulation at Kessler Foundation. “The combination of functional performance, usability, and user-reported outcomes gives this technology substantial clinical relevance.”
Clinical testing at James J. Peters VA Medical Center also contributed to Eve’s progress toward FDA clearance. The studies helped to demonstrate how Wandercraft’s technology has advanced to meet the practical needs of people living with spinal cord injuries and to bring state-of-the-art robotics closer to personal use in everyday settings.
Participants reported improvements in several aspects of daily life, including health status, psychological well-being, endurance during daily activities, lower-limb spasticity, and sitting balance. Some also reported improvements in sleep quality and in bladder and bowel function.
About Wandercraft
Wandercraft is a global robotics company on a mission to restore mobility and expand what’s possible with self-balancing technology. Known for its groundbreaking Personal Exoskeleton, Eve™, Wandercraft is developing the next generation of upright mobility solutions to restore walking ability indoors and during rehabilitation. Atalante X™ is a revolutionary self-balancing exoskeleton used at more than 150 inpatient and outpatient rehabilitation centers worldwide. Wandercraft believes robotics should be built with purpose and help people do what they otherwise couldn’t. Learn more at: Wandercraft.eu.
Contact
Lilly Kofler
Wandercraft
Global Vice President, Growth
lilly.kofler@wandercraft.health
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