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Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System - Vimarsana News

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System

Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System April 26, 2021 07:00 ET | Source: Neurolutions Neurolutions IpsiHand also has been granted U.S. FDA Breakthrough Device Designation SANTA CRUZ, Calif. and ST. LOUIS, Mo., April 26, 2021 (GLOBE NEWSWIRE) -- Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today th...

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients - Vimarsana News

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

FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients News provided by Share this article Share this article SILVER SPRING, Md., April 23, 2021 /PRNewswire/ -- 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 ...

FDA OKs Brain-Computer Interface Device for Stroke Rehab - Vimarsana News

FDA OKs Brain-Computer Interface Device for Stroke Rehab

email article FDA has authorized the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) for stroke survivors trying to regain hand, wrist, or arm function. The IpsiHand System may be prescribed to stroke patients wishing to improve grasping as part of their rehabilitation therapy. The brain-computer-interface device uses non-invasive electroencephalography electrodes to record a person's brain activity, and then moves an electronic hand brace according to the intended muscle movement. "Thousands of stroke survivors require rehabilitation each year," said Chris...

FDA authorizes marketing of a new device for use in patients undergoing stroke rehabilitation - Vimarsana News

FDA authorizes marketing of a new device for use in patients undergoing stroke rehabilitation

FDA authorizes marketing of a new device for use in patients undergoing stroke rehabilitation 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 surviv...