ReWalk Robotics is picking up the pace on its trek down the FDA's review pathway.
The agency has granted ReWalk’s latest offering a breakthrough device designation, giving the company access to an expedited evaluation. Once ReWalk has submitted its regulatory application for the ReBoot system, not only will the FDA prioritize the submission, but experts from the agency will also keep in touch with ReWalk throughout the review so any issues can be addressed as quickly and efficiently as possible.
That process hasn’t yet begun. ReWalk said that it is still finalizing the design and development of the ReBoot device, after which it will launch the clinical trials of the system that are required as evidence in an application for FDA clearance.
“The ReBoot will give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community,” said ReWalk CEO Larry Jasinski in a statement.
The ReBoot system is a soft exoskeleton that’s designed to be worn by patients undergoing rehabilitation for lower limb disabilities caused by stroke and other neurological injuries.
The customizable, battery-powered “exo-suit” uses sensors in a patient’s shoes to detect motion and calculate the amount of support needed, then sends power to the calf and foot to assist with movement, helping with both foot positioning and pushing off the ground.
Though its abilities haven’t yet been proven in clinical trials, ReWalk says ReBoot could potentially improve gait, reeducate leg muscles, prevent muscle atrophy, maintain or increase range of motion, reduce falls and boost walking speed and endurance even without the use of the device.
ReBoot is a “sister product” to ReWalk’s ReStore device, the company said: While both soft suit exoskeletons are designed to improve gait in stroke patients, ReBoot is designed for at-home use. ReStore, meanwhile, was cleared in 2019 for use only in rehab settings.
ReWalk is also the maker of an eponymous rigid exoskeleton that uses a similar mechanism to support both hip and knee motion in people with spinal cord injuries. The original, hospital-only iteration of ReWalk was approved by the FDA in 2011, and the device was cleared for home use in 2014.