Q-Collar will offer protection for the brain from the effects associated with repetitive sub-concussive head impacts

FDA device

The US FDA’s Centre For Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)

Q30 Sports Science has secured approval from the US Food and Drug Administration (FDA) for its non-invasive device called Q-Collar to help protect athletes’ brains during head impacts.

To be worn around the neck of athletes aged 13 years and older during sports activities, the novel device is a C-shaped collar that is designed to provide protection for the brain from the effects associated with repetitive sub-concussive head impacts.

Q-Collar applies compressive force to the neck and enhances blood volume to help reduce movement of the brain within the cranial space that may occur during head impacts.

The device is said to have the potential to minimise the occurrence of specific changes in the brain, which are associated with brain injury.

The FDA’s Center for Devices and Radiological Health’s office of neurological and physical medicine devices acting director Dr Christopher Loftus said: “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.”

Q-Collar offers compressive force to the internal jugular veins to increase blood volume in the skull’s blood vessels, when worn around the neck during sports activities

The device’s increase in blood volume in the blood vessels builds a tighter fit of the brain inside the skull and minimises the slosh movement.

The FDA has evaluated the safety and efficacy of the Q-Collar in various trials, including a prospective and longitudinal study in the US with 284 subjects 13 years or older who were participants on a high school football team.

According to FDA, major changes have been observed in deeper tissues of the brain involved in the transmission of electrical nerve signals in 106 of the 145(73%)  participants in the no-Collar group.

However, no significant changes in the tissues were noticed in 107 of the 139 (77%) of the group who wore the Q Collar.