Wandercraft Releases Eve Self-Balancing Personal Exoskeleton in U.S.

Wandercraft has begun the U.S. commercial launch of Eve, its U.S. Food and Drug Administration (FDA)-cleared self-balancing personal exoskeleton.

Unlike exoskeletons that require crutches or walkers for balance, Eve uses physical artificial intelligence (AI)-powered self-balancing technology to enable upright standing and movement while keeping users’ hands free for activities such as carrying objects, preparing food, and opening doors. The device is intended to complement, rather than replace, a wheelchair as an additional mobility option.

According to the New York-based company, Eve is the first FDA-cleared device in its category without restrictions based on neurological level of spinal cord injury. Eligibility instead includes adults with spinal cord injuries at any level who can safely operate the controller and have no contraindications listed in the user manual.

“FDA clearance showed that Eve was ready to move forward. Today is about making it a reality for the people we built it for,” said Wandercraft’s co-founder and CEO Matthieu Masselin. “We have spent years developing the robotics, but our breakthroughs only matter when we’re able to better connect people to the world around them. That’s why we built an infrastructure that supports people every step of the way, from evaluation and fitting to reimbursement, training, and ongoing service.”

Research supports personal exoskeleton use

Eve’s commercial launch follows peer-reviewed research on training people with tetraplegia and high paraplegia, and their companions, to use a self-balancing exoskeleton for personal use.

Published in the Journal of Visualized Experiments (JoVE), a study from Kessler Foundation and James J. Peters VA Medical Center found all 16 participants who completed the protocol met performance goals for the “Timed Up and Go” and “6-Minute Walk” tests. Fifteen met the donning goal after four training sessions, and all met the doffing goal. No serious adverse events were reported.

Separately, research presented Sept. 8 at the Academy of Spinal Cord Injury Professionals (ASCIP) Annual Meeting reported results from the first 16 participant pairs to complete Eve’s pivotal study at the same institutions. The study found it enabled hands-free assisted walking with a low adverse-event rate. Participants also completed mobility and daily living tasks with high reported safety, satisfaction, and training ease.

Reimbursement pathways are in place for Eve

Personal exoskeletons are covered by Medicare, the Department of Veterans Affairs through USVetServ, and workers’ compensation programs, subject to applicable requirements.

The company’s access team also assists users and care teams with benefits, documentation, reimbursement, financing, and payer coordination. For eligible individuals meeting medical necessity requirements, Medicare covers qualifying personal exoskeletons as custom-fitted orthoses under HCPCS code K1007, subject to applicable coverage criteria.

“With Eve, being upright isn’t just about standing. It’s about having the freedom to use my hands, move through my home, and connect with people in a new way,” said Caroline Laubach, a Wandercraft test pilot. “Those everyday moments bring me so much joy. What makes this milestone especially meaningful is knowing that more people will now have the chance to experience Eve for themselves and find that same joy in their own way.”