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A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway - statnews.com
+ 3 more
11/2/25 at 12:04pm
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STAT
Author
James Smoliga
44 words
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“This is not just about one device. It’s about what happens when institutions grow comfortable living in their own ambiguity and hiding behind opacity.”
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https://www.statnews.com/2025/11/02/q-collar-fda-authorization-science-foia/
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