Dexcom G6 cleared by FDA with 

  • no fingerstick calibrations
  • 10-day wear time
  • approval for ages 2 years and older
  • no acetaminophen interference
  • and more

The FDA just cleared the Dexcom G6 CGM today, only six months after it was submitted to the FDA and far earlier than we expected! A launch is expected later this year, and we’ll learn more specifics soon.

G6 will not require any fingerstick calibrations, a tremendous win that was hoped for, but not officially confirmed until today. G6 also comes with a seriously improved new one-button insertion device, a 28% smaller profile transmitter (about two-thirds of the original size), longer 10-day wear time, no acetaminophen interference, and approval for ages 2 years and older.  Like G5, G6 remains a real-time CGM approved for insulin dosing. It will send data to Apple and Android apps, as well as a touchscreen receiver. Along with the standard CGM alarms, it also adds predictive alerts for lows, which will sound before a low is reached.

In very notable news, the FDA has also paved the way for faster CGM innovation. Starting with the G6, the FDA has created a new category of devices called “Integrated Continuous Glucose Monitors,” or “iCGM.” This means that the G6 CGM is cleared with interoperability in mind, meaning it will simplify the FDA review process for other devices that talk to G6. For instance, a pump that talks to the G6 CGM might have a streamlined FDA review, since the G6 is has this interoperability iCGM designation – nice! Because G6 is now an iCGM, the FDA has also changed its risk category from “high risk” (Class III) to “lower risk” (Class II) – this will likely enable faster FDA reviews of future Dexcom CGM innovations and products that talk to Dexcom CGMs.

(Buzz on the do-it-yourself sites:  there is a hard shut-off at 10 days, as required by FDA but there may be a workaround which might require daily calibrations)

QUESTION:  Now what is Medicare going to do?  Will they cover this device, as they will no longer have to supply meters and test strips?  Stay tuned!

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