ReWalk Robotics is a prominent global producer of robotic medical equipment for people who have problems with their lower limbs. FDA has designated ReWalk Robotics’ ReBoot device as a Breakthrough Device, the company said today. RWLK stock strikes 55% in today’s pre-market to $2.00 from $1.29 as of yesterday. ReBoot is a custom-made orthotic exo-suit that’s designed to support individuals with limited mobility due to stroke or other neurological injuries. It’s powered by a battery-operated motor. ReBoot, which was designed to be a customized device for stroke survivors, has received a breakthrough device designation from the US Food and Drug Administration. ReBoot works in combination with the muscles of the leg to help people maintain safe foot positioning and also improve their walking style.
The Breakthrough Devices program is a program that was specifically created to select medical devices or combined medical products created by devices that provide diagnostics of rare diseases or effective treatment for them. The goal of the program is to help patients obtain faster access to medical devices by facilitating the development, assessment, and review of new medical devices. The FDA’s Breakthrough Devices Program provides manufacturers with an opportunity to interact with the agency’s experts to address any of the topics that arise during the premarket review process. This program can help them receive feedback and identify areas of agreement within a timely manner.