Feb. 27 (UPI) — The Food and Drug Administration authorized marketing of a device intended to help athletes reduce the risk of traumatic brain injury Friday.
The device, called the Q-Collar, is a C-shaped collar that applies compressive force to the neck, helping reduce the movement of the brain at head impacts — which can cause traumatic brain injury.
The FDA said it assessed the safety and effectiveness of the Q-Collar through several studies, including a study involving 284 subjects 13 years or older who played high school football.
During the football season, 139 students wore the Q-Collar and 145 did not, and each underwent MRI scans before and after the season.
Researchers found “significant changes” in brain tissue in 73% of the students who didn’t wear collars.
Of those who wore the collar, the majority — 77% — did not show significant changes.
The study also didn’t find significant adverse events linked with device use.
The FDA noted that the data did not demonstrate that the device prevents concussion or serious head injury, and that it should not replace other protective equipment.
“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 Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.
The device will be sold over the counter and is intended to be used by athletes aged 13 older during sports activities.
Carolina Panthers Linebacker Luke Kuechly, who retired last year at 28 after suffering several head injuries, was seen wearing the Q-Collar in his final seasons with the NFL.