Boo! Looks like a late 2022 approval with a 2023 commercial launch. Not sure why what was good enough for a CE mark wasn’t good enough for the snobs at FDA.
Yeah, this really made me change my plans. I wanted to wait until the G7 came out to switch to the OmniPod 5 looped system since the G7 was supposed to be better at staying connected to everything else, but then the FDA told Dexcom, “No.” I have decided to go ahead with the OmniPod 5 using the G6 for now.
What has me worried, (and I quote from the article you attached), that Dexcom’s CEO said, “We decided the best option at this time was to revise the software and file it differently, and we have added a few other features to it as well based on our discussions with [the FDA,]” the CEO said. “We’re in the middle of revising the software for that and have to run it through the complete validation and verification process and resubmit [the application.]”
OK, so by the time they finish the software revisions, run the validation tests and verification process, resubmit the whole shebang for FDA approval, is there ANY way the G7 is going to come out in 2022? Even early 2023? Ha! I think not.
Having waited for diabetic equipment releases for the past 56+ years, I automatically add 6 months to a year to any predicted product release.
Don’t get me wrong. If the FDA really did find problems with G7, then I want those problems addressed. But I think we all are in for a longer wait for the G7 than we had anticipated. I am guessing third to fourth quarter of 2023 for US general release, if then.
The software revisions are related to the management of the alerts and alarms in the system for the U.S. mobile application, according to Sayer.
Yerk. The G6 is bad enough, going totally mad and yelling at the top of its voice. Maybe a few diabetics with failing G6s or, perhaps, just low BG should visit a meeting of the FDA all at once. Or maybe the FDA did something sensible and want Dexcom to allow us to STOP the noise; on an iPhone even turning the volume switch off no longer works.
Sayer added that going forward, the company will probably make more incremental changes to newer versions of CGMs.
What did they actually change? 2 hours->30 minutes, add a “slot” so that three devices can connect, put the transmitter in with the sensor. I can see that the FDA would care about the first; I don’t have a usable G6 after 2 hours and sometimes not after 8. Yet that is not an “alert” or, indeed, a new feature. Adding a slot, so what? Putting the transmitter into the sensor, that should give the FDA much comfort given that transmitters are frequently half way through their shelf life when I get them.
I’m with you completely on the date. 2023. I suspect Dexcom will suddenly find that the European market is very lucrative now that the authorities there are buying into everyone benefiting from a CGM and that the US market will seem small because of the high price stopping people in the US using the product.