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by veidr
852 days ago
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Yeah, noteworthy point. Also, I think the article is weirdly sensationalized — the FDA isn't "against" anything here. If you click through to the FDA's bulletin[1], it's merely stating for clarity and public awareness that there are currently no non-invasive CGM devices that actually meet existing standards for accuracy. If somebody did produce one, it could be validated and approved via the same processes used by all the existing CGM products which have been approved. [1]: https://www.fda.gov/medical-devices/safety-communications/do... |
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