FDA

FDA Authorizes New Device that Protects the Brain From Head Hits

By MedTech Intelligence Staff
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FDA

The Q-Collar uses jugular compression to help protect an athlete’s brain from the effects of repetitive head impacts.

Today the FDA authorized a non-invasive device that can help protect athletes’ brains from the effects of repetitive head impacts. Worn around the neck, the Q-Collar is a C-shaped collar that “applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts. The device may reduce the occurrence of specific changes in the brain that are associated with brain injury,” according to the FDA.

How it works: “When worn around the neck during sports activities, the Q-Collar provides compressive force to the internal jugular veins, which in turn increases the blood volume in the skull’s blood vessels. Typically, when people experience blunt trauma accidents, the brain moves unrestrained in the skull, which is known as a ‘slosh.’ The Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces the “slosh” movement. By reducing the movement of the brain within the cranial space, the Q-Collar may aid in the protection of the brain from the effects of head impacts.”

Manufactured by Q30 Sports Science, LLC, the Q-Collar does not replace helmets and should be worn with other protective sports equipment, including helmets and shoulder pads. The agency states that users should also continue to try to avoid direct impacts to the head and neck, as use of the device does not prevent concussion or serious head injury. Athletes ages 13 and older can wear the device for up to four hours at a time. The Q-Collar is over the counter and was reviewed by FDA through the De Novo process. Q30 Sports Science/Q30 Innovations spent eight years developing the product and submitted its request for FDA authorization in May 2020.

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