FDA Authorizes New Device That Protects Athletes’ Brains During Impact

The United States Food and Drug Administration recently authorized a novel product that recent Magnetic Resonance Imaging (MRI) shows might protect athletes’ brains from traumatic injury.

A c-shaped, non-invasive device dubbed the “Q-Collar” goes around the neck and applies compression, which increases blood volume, therefore reducing brain movement.  

Several FDA studies proved the effectiveness and safety. One such study included a long-term analysis of 284 participants, age 13 and older. A total of 139 athletes wore the collars, and 145 did not; both underwent head MRI before and after the season.

To compare structural changes after a season of play, researchers also generated diffusion tensor imaging of the brain. Significant differences were noted in the deep tissue involved in transmitting electrical nerve signals in 73 percent of the collarless group. Those who were equipped with the Q-Collar showed no change in white matter throughout 77 percent of the group.

“These differences appear to indicate protection of the brain associated with the device use. No significant adverse events were associated with device use,” The FDA’s Center for Devices and Radiological Health reported.

An estimated 3.8 million sports-related traumatic brain injuries occur in the United States yearly, according to The National Institute of Neurological Disorders and Stroke.

Along with the Q-Collar manufacturer Q30 Sports Science, FDA officials hope the device will lower this number, reducing “slosh” by creating a tighter fit of the brain in the skull through increased blood volume.

The Q-Collar should not be used in place of helmets or other protective devices. Athletes with a history of seizure disorders, brain blood clots, or problems with blood clotting, in general, should not use the device.

For more information, read the full FDA report.

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Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.