The self-balancing Eve system can help wheelchair users with spinal cord injuries walk upright via its hand controls, and can then stay standing hands-free without crutches or a walker to allow the wearer to carry objects or open doors.
The company describes Eve as the first FDA-cleared device in its category, and it is now available to adults with spinal cord injuries at any neurological level. After a clinical evaluation and trial run, the exoskeleton is personally fitted and manufactured, followed by an individualized training program with the Wandercraft team and its partners before delivery.
“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 co-founder and CEO Matthieu Masselin. The company raised the curtain last week at a Sept. 17 event in New York City with the United Spinal Association.
“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,” Masselin added.
The company said that personal exoskeletons are covered by Medicare as custom-fitted orthoses, and that it is working to secure reimbursements from private insurance providers.
Eve’s FDA clearance in August was supported by a three-site clinical trial in the greater NYC area, with participants reporting improvements in health status, psychological well-being and endurance during daily activities.
The company previously obtained multiple agency green lights for its Atalante X self-balancing exoskeleton, designed for gait training in rehabilitation. Meanwhile, a paraplegic person wearing an early prototype for Eve participated in the torch relay for the 2024 Olympic Games.
Last year saw developer Lifeward launch its latest ReWalk 7 exoskeleton for people with spinal cord injuries, while German Bionic debuted its Exia lift-assistance device for industrial use.
