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

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

statnews.com/2025/11/02/q-collar-fda-authorization-science-foia

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…

This story appeared on statnews.com, 2025-11-02 15:27:06.567000.