FDA Authorizes Marketing of Device to Facilitate #Muscle Rehabilitation in #Stroke Patients

Today, the U.S. Food and Drug Administration authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability.

“Thousands of stroke survivors require rehabilitation each year. Today’s authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health..

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