FDA authorizes Dexcom G6 - First Fully Interoperable Continuous Glucose Monitoring System

FDA News Release

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices



Wow. That was WAY faster than I expected.
I am wondering if the sensor can still be restarted? I understand it is only FDA approved for the 10 days. But of course historically, Dexcom users have always been able to restart their sensor if they so choose to do so. Previously the Dexcom CEO has stated he had no intentions of restricting this but then in the most recent earnings call, he indicated that the FDA might force a restriction in order to allow the factory calibration to go through. So, I wonder which way it went…

Also if you missed the notes from the last conf call, the Dex CEO had said that although this is “no calibration” (or factory calibration depending on how you phrase it) that the system would actually be allowing “OPTIONAL” calibrations. I am anxious to read the final G6 User Manual and see what all the details are - how much was tweaked before the release/approval.

The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.

Fingerstick Elimination – No fingersticks are needed for calibration or diabetes treatment decisions.

Easy Sensor Applicator – Complete redesign of the sensor applicator allows for one-touch, simple insertion.

Acetaminophen Blocking – New feature allows for more accurate glucose readings with no medication interference.

Predictive Low Alert – New alert feature predicts hypoglycemia before it hits to help avoid dangerous low blood sugar events.

Extended 10-Day Sensor – 10-day sensor allows for 43% longer wear than previous generation Dexcom CGMs.


Ah you were faster than me haha I just shared

I might go delete in some mins. :slight_smile:

Great news!