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.
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The FDA said it based its recommendation on a number of studies, including one that compared changes in brain structure between high school football players who wore the Q-Collar versus those who did not. All participants were 13 years and older.
The researchers used advanced imaging techniques to look at changes in the brains of nearly 300 study participants before and after the season. They found changes in deep structures of the brain in 73% of participants in the no-collar group, while no significant changes in these same structures were found in 77% of participants in the collar group.
Carolina Panthers' Linebacker Luke Kuechly, who retired at 28 after suffering a series of head injuries, was seen wearing the Q-Collar in his final seasons with the NFL.
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"Today's action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport," said Dr. Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA's Center for Devices and Radiological Health.
The data provided for the Q-Collar did not demonstrate that the device prevents concussion or serious head injury, 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.