ReWalk submits FDA application for stroke device
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ReWalk's prototype for a system to help stroke patients walk.
ReWalk Robotics, the Marlborough manufacturer of wearable robotic systems for people with disabilities, has submitted regulatory filings to begin the commercialization of a system for stroke patients and hospitals.
The company, with operations in Israel and Germany, has submitted a 510k filing to the U.S. Food & Drug Administration for its Restore exoskeleton suit.
The product was first unveiled in 2017 and is designed to be a cost-effective gait therapy solution, the company said.
The suit is constructed with a garment-like material to allow variable movement. The suit is equipped with ankle assistance and synchronizes with the patient’s natural walking pattern.
Therapists can adjust the suit to optimize treatment using real-time analytics, according to ReWalk.
The submission follows a nationwide clinical study including 44 patients across five rehabilitation centers, including the Spaulding Rehabilitation Hospital in Boston in partnership with Boston University.
The company applied for CE approval in Europe in the fourth quarter of 2018 and anticipates commercializing the ReStore device in Europe in the middle of 2019.
A potential U.S. launch of the product is eyed for late second quarter or third quarter, the company said.
In a statement, ReWalk CEO Larry Jasinski called the submission a significant milestone for the company and robotic rehabilitation technologies.
“The company is proud to continue its work in revolutionizing devices for mobility challenged individuals, and to be at the forefront of next-gen development in medical exoskeletons,” Jasinski said.
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