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.
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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.
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