November 2, 2025
1 min read

Opinion: A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway

The Q-Collar — a neck collar inspired by the woodpecker — has been worn by NFL players and thousands of young athletes. When it debuted in 2012, it originally promised to reduce concussion risk by lightly squeezing the jugular veins, supposedly stabilizing the brain. By 2019, it started to use more ambiguous language, saying the device could “protect the brain.” The company raised tens of millions of dollars and proudly advertises that it is “FDA authorized.” To most consumers, that sounds like proof.

It isn’t, as a colleague and I detailed in an investigation in The BMJ recently.

Read the rest…

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