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mHealth Platform for Stroke Rehabilitation Gains Federal Approval

The US Food and Drug Administration will allow ReWalk Robotics to market its mHealth wearable for mobility rehabilitation to stroke centers and other care providers working with stroke survivors to improve lower limb movement.

Source: ThinkStock

By Eric Wicklund

- The US Food and Drug Administration has given its approval to an mHealth wearable designed to help stroke victims work on regaining movement and coordination in their legs.

The FDA action enables Massachusetts-based ReWalk Robotics to market its ReStore soft exo-suit system to rehabilitation centers and other care providers working with stroke victims. The connected health platform is reportedly the first exo-suit to receive FDA clearance, and is one of a leading edge of mHealth products aimed at improving care management through wearables and clothing.

The announcement comes as the company is in the midst of a five-center clinical study of the mobile health tool. Results of that study should be released sometime this year.

“The idea of anchoring the body with textiles and flexible soft components is a fundamentally new way of applying assistance with a wearable robot,” Conor Walsh, who helped to develop the exo-suit, said in a press release issued by ReWalk.

“This technology has broad potential, and we are currently testing additional concepts which can be applied to provide therapy and/ or mobility assistance for individuals with other diseases, such as multiple sclerosis and Parkinson’s disease, and also potentially be used by a person at home and in their community,” said Walsh, a professor of Engineering and Applied Sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and a Core Faculty member at the Wyss Institute for Biologically Inspired Engineering.

Walsh led the team to develop the wearable in Harvard’s Wyss Institute, and in 2016 the school signed a partnership with ReWalk to continue development for stroke treatment and other therapies.

“We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities,” Alberto Esquenazi, MD, Chief Medical Officer at Pennsylvania’s MossRehab – one of the five clinics involved in the study – said in the release. “By training the patient walking pattern in a more correct way, the expectation is that the brain will re-learn and better restore the walking function lost after a stroke.”

The exo-suit consists of a garment connected to a waist pack and cables that help guide the patient during walking exercises. The platform focuses on plantarflexion (forward propulsion) and dorsiflexion (ground clearance), and collects real-time movement data for care providers.

The company previously developed the ReWalk Personal 6.0, a robotic exoskeleton for home use by individuals with paralysis from a spinal cord injury.

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