Breakthrough Device Designation to the ReWalk ReBoot Soft Exo-Suit
FDA awards the ReWalk ReBoot Soft Exo-Suit
ReWalk Robotics, Ltd. announced its ReBoot device has been granted designation as a Breakthrough Device by the Food and Drug Administration (FDA). The ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries, such as stroke. The ReBoot is a customizable personalized device intended for home and community use. It is a sister product to the ReStore device, which received FDA clearance in 2019 for use in the rehabilitation setting.
The ReBoot is a lightweight, battery-powered orthotic exo-suit.
"Breakthrough Device Designation from the FDA is a critical milestone for the ReBoot, as it provides a more streamlined review pathway that can get this uniquely innovative device to market faster," said Larry Jasinski, CEO of ReWalk. "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."
The ReBoot works in conjunction with the muscles of the affected leg to assist individuals not only with maintaining safe foot positioning but also with pushing off the ground, which means it may improve their gait. It may also:
Facilitate muscle re-education, particularly of plantarflexor function;
Prevent/retard disuse atrophy;
Maintain or increase joint range of motion;
Improve walking speed and endurance independent of the device; and
Reduce incidence of falls due to poor foot positioning secondary to footdrop.
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo request”). The program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health. The Breakthrough Devices Program offers manufacturers such as ReWalk an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help us receive feedback from the FDA and identify areas of agreement in a timely way. The program also provides manufactures such as ReWalk prioritized review of their submission.
With this designation, ReWalk will now readily pursue the FDA approval pathway for the ReBoot. The company is finalizing the ReBoot’s design and development and will proceed to the clinical studies required for FDA clearance application.