March 2, 2021
The U.S. Food and Drug Administration (FDA) on Thursday approved a device meant to minimize the damaging effects of repetitive impacts to the head in athletes 13 and older.
The Q-Collar is a C-shaped device that applies compression to the neck and aims to reduce the movement of the athlete’s brain with the cranial space, which could occur during impacts to the head area, the FDA said. The device might reduce changes to the brain associated with brain injuries.
“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,” 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, said in a news release.
Q30 Innovations, which developed the Q-Collar aiming to help protect the brain from injuries, applauded the agency’s decision to approve the device.
“FDA approval is the global gold standard for demonstrating the safety and efficacy of a medical device. For nearly a decade, we have invested in world class, independent scientific research conducted by leading academic and medical institutions to bring this novel device to the US marketplace. We thank the team at the FDA for their work and are pleased they have confirmed that that the Q-collar can aid in the protection of the brain from the effects of repetitive sub-concussive head impacts,” Q30 Innovations co-founder and co-CEO Tom Hoey said in a news release.
“This announcement is another major milestone for our company and we are proud to provide athletes with an effective, tested and verified solution to reduce the risk of traumatic brain injuries,” he added.
Former Carolina Panthers linebacker Luke Kuechly wore the device starting during the 2017 season. The collar fit on his neck between his helmet and shoulder pads. Kuechly suffered two concussions before the 2017 season and one in 2017.
He retired after the 2019 season.
The FDA advised that the Q-Collar be worn with other equipment, but the wearers of the device should not count on it to prevent head injuries.