The U.S. Food & Drug Administration has granted breakthrough device designation for an exo-suit helping people with neurological-injury-related ankle issues walk, according to ReWalk Robotics, Ltd. of Marlborough, which makes the technology.
This designation for the device, named the ReBoot, means its development, assessment, and review may be expedited, per a Thursday announcement.
“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, in a statement.
The ReBoot is a battery-powered orthotic exo-suit designed to help individuals with reduced ankle function related to neurological injuries, such as stroke, walk. It’s designed to be used both inside and outside the home and is considered a sister product to ReWalk’s ReStore device, which the FDA cleared for use in rehabilitation settings in 2019.
With the designation, ReWalk plans to pursue the FDA approval pathway for ReBoot.