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The C-shaped device, called the Q-Collar, fits around the back and side of the neck. It works by blocking blood vessels in the neck, which increases blood volume in the skull. This restricts the movement of the brain inside the skull, which the researchers say usually causes traumatic brain damage.
The FDA said it based its recommendation on a number of studies, including one comparing changes in brain structure between high school football players who wore the Q collar and those who did not. All participants were 13 years and older.
The researchers used advanced imaging techniques to examine changes in the brains of nearly 300 study participants before and after the season. They found changes in deep brain structures in 73% of participants in the collarless group, while no significant changes in these same structures were found in 77% of participants in the collar group.
“Today’s action provides additional protective gear that athletes can wear while playing sports to help protect their brains from the effects of repetitive impacts to the head while wearing the associated personal protective equipment. to sport, ”said Acting Dr Christopher M. Loftus. director of the Office of Neurologic and Physical Medicine Devices at the FDA’s Center for Devices and Radiologic Health.
Data provided for the Q collar has not shown the device to prevent concussions or serious head injuries, the FDA said. And the Q-Collar should not replace other protective equipment associated with sports activities.
The device will be sold over the counter directly to consumers.
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