FDA Authorizes Device to Protect Athletes’ Brains from Impacts
The US Food and Drug Administration (FDA) has cleared Q-Collar—a novel, noninvasive device to be worn around the neck among athletes aged 13 years or older to help protect the brain from the consequences of repeated subconcussive impacts to the head.
Q-Collar works by applying compressive force to the internal jugular veins in the neck and increases blood volume, which may keep the brain from moving as much within the cranial space during head impacts. Q-Collar may also help decrease specific changes from happening in the brain that are tied to brain injury.
The device can be worn for up to 4 hours at a time. Users should replace the device after 2 years of active use or upon the product’s expiration date listed on the packaging (whichever date arrives first).
The FDA warns that Q-Collar is not intended as a replacement for other protective sports equipment like helmets and shoulder pads, but should be worn with these pieces. The FDA adds that Q-Collar has not been tested and should not be used among athletes with increased pressure in the skull, increased acid presence in the body or excessive blood alkalinity, open head injury within the prior 6 months, blood clot in the brain, or known seizure disorders, among several other conditions.
More information about the device, as well as contraindications, can be found here.
FDA authorizes marketing of novel device to help protect athletes’ brains during head impacts. News Release. US Food and Drug Administration. February 26, 2021. Accessed March 1, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-novel-device-help-protect-athletes-brains-during-head-impacts