{"id":8052,"date":"2025-11-02T23:02:23","date_gmt":"2025-11-02T23:02:23","guid":{"rendered":"https:\/\/mailitics.com\/index.php\/2025\/11\/02\/q-collar-fda-authorization-science-foia\/"},"modified":"2025-11-02T23:02:23","modified_gmt":"2025-11-02T23:02:23","slug":"q-collar-fda-authorization-science-foia","status":"publish","type":"post","link":"https:\/\/mailitics.com\/index.php\/2025\/11\/02\/q-collar-fda-authorization-science-foia\/","title":{"rendered":"Opinion: A sports device to \u2018protect the brain\u2019 illustrates a major problem with the FDA de novo pathway"},"content":{"rendered":"

Opinion: A sports device to \u2018protect the brain\u2019 illustrates a major problem with the FDA de novo pathway
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The\u00a0Q-Collar \u2014 a neck collar inspired by the woodpecker<\/a> \u2014 has been worn by NFL players and thousands of young athletes. When it debuted in 2012, it originally promised<\/a> 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 \u201cprotect the brain<\/a>.\u201d The company raised tens of millions of dollars and proudly advertises that it is \u201cFDA authorized.\u201d To most consumers, that sounds like proof.<\/p>\n

It isn\u2019t, as a colleague and I detailed in an investigation in The BMJ<\/a> recently.<\/p>\n

Read the rest\u2026<\/a><\/p>\n<\/div>\n

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\n James Smoliga
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\nGo to statnews<\/a>
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Opinion: A sports device to \u2018protect the brain\u2019 illustrates a major problem with the FDA de novo pathway The\u00a0Q-Collar \u2014 a neck collar inspired by the woodpecker \u2014 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 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1537,2146,2143,1428,2151],"tags":[2150],"class_list":["post-8052","post","type-post","status-publish","format-standard","hentry","category-ethics","category-fda","category-first-opinion","category-health","category-policy","tag-statnews"],"_links":{"self":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8052"}],"collection":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/comments?post=8052"}],"version-history":[{"count":0,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/posts\/8052\/revisions"}],"wp:attachment":[{"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/media?parent=8052"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/categories?post=8052"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mailitics.com\/index.php\/wp-json\/wp\/v2\/tags?post=8052"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}