if you're displaying a glucose value and that is a real-time glucose value and that is where we've been in our discussions with the FDA that's a class 2 medical device and as of the day that requires a prescription
The headline is broadly defensible, but the qualifications matter. Effect sizes vary by population, the strongest claims rest on shorter trials, and credible voices push back on how it's typically framed.
if you're displaying a glucose value and that is a real-time glucose value and that is where we've been in our discussions with the FDA that's a class 2 medical device and as of the day that requires a prescription
Every Sunday: the week’s new conflicts and verdict changes — and nothing else.
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Bookmarking — the dossier-vs-overview split is the right call. Most of the time I want overview; sometimes I want receipts.
Would love a "what would change this verdict" RSS feed. Sign me up if it exists.
everything we've talked about as you said is still a medical device and it's a class to medical device physician writes a prescription and I'm only just talking about the cash patient so this is not about insurance anymore
Continuous glucose monitors are still considered a medical device... for that reason, they are prescribed under the care of a physician. However, increasingly, they're fairly commoditized with companies like NutriSense, January.AI and Levels, making them available to virtually anyone through a physician network and selling them usually for around a couple hundred dollars per month with the most well-known CGM brands being the Dexcoms and the Freestyle Libre.
Post-meal glucose spikes in non-diabetics drive long-term cardiometabolic disease independently of HbA1c.
Wearing a continuous glucose monitor leads to personalized dietary improvements that hold up beyond 12 weeks.
Continuous glucose monitors meaningfully change behavior in non-diabetic adults beyond the first month.
CGM use in metabolically healthy adults induces orthorexic-style dietary anxiety without health benefit.