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 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.
FDA Clears Brain-Computer Interface Device to Aid Stroke Rehab
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FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
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WESTPORT, Conn., March 1, 2021 /PRNewswire/ Q30 Innovations is pleased to announce the FDA s recent authorization to market the Q-Collar in the United States. The FDA clearance is a major step forward in the company s mission to help better protect athletes from the effects of repeated head impacts.
The FDA s decision was based on a rigorous review of eight years of scientific research and clinical trials that demonstrate the safety and efficacy of the Q-Collar, including prospective, longitudinal studies in the United States with approximately 450 male and female athletes. The football study showed that over the course of a season of play, 77% of the collar wearing athletes had no significant changes in their deep brain tissues (white matter), compared to 73% of non-collar wearing participants who experienced significant changes. No adverse events have been associated with the use of the Q-Collar.