New Omnipod in at FDA for approval?

My Endo mentioned today that Omnipod has a new pump in for approval at the FDA. I can’t seem to find anything on it. Does anyone know anything about it?

I talked with a rep yesterday who said that too but had no other info about it. I guess it’s wait and see…

Must be the one with bluetooth and Android-based PDM.

2 Likes

Perhaps the Dash system, as @Helmut suggests?

OmniPod Dash, diaTribe - https://diatribe.org/insulet-omnipod-dash-system-to-add-touchscreen-and-bluetooth

Yes, it’s the bluetooth pump with Android PDM. It’s expected to roll out before the end of the year. The PDM will incorporate Dexcom G5 data, but not for insulin delivery, only for calculations. We’re probably looking at 2019 for a semi-automated pumping system from OmniPod.

EDIT: I guess I should have read Lorraine’s link. It’s all there.

1 Like

But much easier to read when it’s all right here. :slight_smile:

Thanks for the link. That really helped. Then there was a link on that page that gave you more information on several manufacturers. It is exciting to see so many manufacturers developing closed loop systems.

Thank you to all who replied.

1 Like

It’s not yet filed with the FDA.

As of Feb. 28, they were still finishing their human factors clinical work and were planning to submit to FDA in the coming few months – but not yet. They are shooting for an end-2017 launch, depending on FDA consideration.

2 Likes