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Share this article Share this article 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. ....
The Q-Collar applies compressive force to the neck and increases blood volume to help reduce movement of the brain, which may occur because of hits to the head. ....
Traumatic Brain Injuries Could Now Be Prevented With This FDA Approved Device ibtimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from ibtimes.com Daily Mail and Mail on Sunday newspapers.
A new device that could help reduce the risk of traumatic brain injury during head impacts was given the green light by the U.S. Food and Drug Administration on Friday. The device is authorized for athletes 13 and older, and can be used during football, soccer and other high-impact sports. The C-shaped device, called the Q-Collar, fits around the back and side of the neck. It works by clamping down on blood vessels in the neck, which increases blood volume in the skull. This limits the movement of the brain inside the skull, which researchers believe generally causes traumatic brain injury. ....
FDA approves new device to help protect athletes from traumatic brain injury channel3000.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from channel3000.com Daily Mail and Mail on Sunday newspapers.