First self-balancing personal exoskeleton launched in US

French company Wandercraft has begun commercial sales in the United States of its personal exoskeleton, Eve, which can independently maintain balance and enables users to stand and walk with their hands free. The device has received clearance from the U.S. Food and Drug Administration (FDA), El.kz reports.

Eve is designed for adults with spinal cord injuries who use wheelchairs and are able to operate the device’s controller independently. The FDA has authorized its use regardless of the neurological level of the injury.

The exoskeleton’s key feature is its self-balancing system. Users do not need to continuously rely on crutches or use their hands to maintain balance, allowing them to open doors, carry objects, or perform certain daily activities while walking. The company describes Eve as the world’s first self-balancing personal exoskeleton to receive FDA clearance.

At the same time, the device is not intended to fully replace a wheelchair. Instead, it is offered as an additional mobility option for situations in which the user needs to remain in an upright position.

Eve may only be used following a medical assessment. The exoskeleton is classified as a Class II medical device and is available by prescription from a licensed healthcare professional.

Following a successful assessment, the device is individually fitted to the user and custom-manufactured. The user must then complete specialized training covering operation of the controller, walking on level surfaces, movement in confined spaces, and procedures for responding to emergencies.

There is also an important safety requirement: a trained attendant must be present during every use. The attendant must have completed training together with the user and be capable of providing assistance in the event of loss of balance or another emergency situation.

Eve was commercially launched in the United States on 17 September. Wandercraft plans to expand access to the device through insurance programs and other financing mechanisms.

The company already uses similar technology in its Atalante X rehabilitation exoskeleton. According to Wandercraft, such systems are currently in use at more than 150 rehabilitation and research centers worldwide.