FDA Designates ReWalk’s ReBoot Soft Exo-Suit a Breakthrough Device

ReWalk Robotics’ ReBoot device has been designated a breakthrough device by the FDA.

The ReBoot is a customizable personalized device intended for home and community use and a sister product to ReWalk’s ReStore device, which received FDA clearance in 2019 for use in rehabilitation settings, according to the Marlborough, Mass.-based company.

ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in people with reduced ankle function related to neurological injuries, such as stroke. It works in conjunction with the muscles of the affected leg to assist with maintaining safe foot positioning and with pushing off the ground, which means it may improve users’ gait.