FDA Awards Breakthrough Device Designation to the ReWalk ReBoot Soft Exo-Suit for Stroke Rehab at Home

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 and is 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.

“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 comes out of work done by the group at the The Assistive Technology Initiative at Harvard University’s John A. Paulson School of Engineering and Applied Sciences as well as the Neuromotor Recovery Lab at Boston University.  It 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.

Check out the full press release here: https://www.wsj.com/articles/fda-awards-breakthrough-device-designation-to-the-rewalk-reboot-soft-exo-suit 

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