The company reported earnings yesterday and in its conference call to analysts said it is still targeting the conversion to the smaller pods for US customers by the end of this year. Final FDA approval still has not come through, even though the smaller pods are already being sold in Europe. Of course, officials can't predict exactly when the FDA will sign off, but they are very hopeful that patients can be converted to the new pods by the end of the year. It's a win-win. Patients will like the smaller form factor, and the margins for the company are greater. They plan to begin building inventory soon. What they don't want is for supply chain problems to force patients back to the larger pods after they have been converted to the new ones. The company is still working on a device that incorporates a CGM from Dexcom.
was there any update on when we will see the smaller pods in Canada ?
Look how long it took the Omnipod to get here in Canada - way too long in my mind. I, unfortunately am not holding my breath. At least we have these ones now which makes me VERY happy, maybe the process will be a wee bit quicker this time around. My fingers are crossed.
Thanks for the news Jim! I'm starting new to Omnipods this weekend. Tried to hold off for the new versions, but opted to just get started.
In the Netherlands the Omnipod was launched in 2011 and it seems that the 2e generation is coming first to Holland. http://www.mylife-diabetescare.nl/mylife-omnipod.html So Canada good well be the first outside Europe. The way Ypsomed plans their launches is .............
I agree.. if there are too many problems with the new ones, people will probably go back to the other types of pumps. I don't see why they can't just add something to the pod to do the CGM.. rather than wear the 2 different pieces all the time with the other company. Anyway, today is hook up day and again, I appreciate all of the great information on here! Wish me luck people ;)
Management says the delays have to do with new practices at the FDA. The technology for both the new pods and the CGMs have been approved, as the technology hasn't really changed for the pods and the CGM is basically the same as what is in use today. However, putting the two together (or in a slightly different form as in the new pods) requires a totally new review procedure as if the technology were totally new. In the case of the new pods, the FDA has come back with some questions, but nothing major that hasn't been easily answered. It's the government, however, with its own timetable, and the process can't be rushed, apparently.
Awesome news Jim. thanks for the update. Can't wait for new pods and Dex+Omnipod integration.
Maybe this is why Liberty medical keeps sending me 5 boxes of pods evry 3 months! Perhaps they are trying to get rid of the old pods! I now have about a 9 month supply of pods!
I would call them and tell them not to send you any more pods until you call them and place an order. Good grief!
I'd love to see a better meter too. I'm fed up with Freestyle and Abbott!
so how did hook up day go ?? i started may 18th..
where in Europe are they being used? And by end of year do you mean by December? As you probably can tell I am anxious for this to happen....
Holland will be the first country: the new pods are coming from china, they should be already here. I think they are teaching the teams on the new product ...
I'm really excited about the new, smaller pods and can't wait til they release them here. And can I just say... I hate the FDA! It's ridiculous how many hoops they're making them jump through for an already established technology... just made smaller:X
I agree, how about if I volunteer to test for them, anybody know how about doing this? If possible???
I had contact with Ypsomed in Holland and they told me they are still waiting for the new PDM.
They could not give me an estimate but hoped to start in about 7 weeks with distributing the 2e generation Ipod’s.