They got held up by changes in the FDA device approval protocol, which has affected all pump manufacturers who were getting closer to getting new products out. Hopefully the announcement the other day that the FDA would work to streamline its device approval process so that technology which may improve disease management can actually get to the people who need/want it. Odd how so many devices seem to make it to the public in other parts of the world much more quickly than in the US...
We've been using the OmniPod since Jan. 2008 and Insulet has been saying the new, smaller pods are going to be release "in the next six months" - it's been over 2 years and we're still hearing "in the next six months" - so don't hold your breath on waiting for this to happen!! I'll believe it when I see it!
While we love our OmniPod, I don't love the fact that they release all these statements about new products and nothing happens. A great example is the phasing out of the old test strips to the new butterfly one's - all of us are expected to use the butterfly strips without FDA approval - this is horrible customer service and does a disservice to our kids. We are using these test strips but I have to say, I'm not happy to be using strips that aren't approved for our PDM. This is the companies way of covering their butts if our kids end up hospitalized. Not good.
During the last earnings call Insulet mentioned that they expect to file an application for the smaller pod in the second quarter and expect availability later this year. I was surprised to hear that Insulet does not expect to file for the DexCom integration until next year.
They want to integrate the smaller pods with Dexcom's Generation 4 CGMS (also currently waiting on FDA approval). They can't file until Dex submits more info to FDA for Gen 4. Next year is probably realistic for the filing, may be late 2012 or even 2013 before it is ready for market.
Late last year at a financial conference, Insulet announced that they were ramping up to launch the new pods in conjunction with the Summer 2011 ADA meeting. Unfortunately, then the FDA requested a small clinical trail. Since that time, the FDA has upped the clinical trial requirements even more. And in the last couple of weeks the FDA has implied that they will add more stringent requirements on medical device makers (maybe even a full PMA process)--specifically including insulin pump companies--for the release of produts that are "similar" to existing products. In the past, products that were based on existing technology (i.e. the old pod vs new pod) could sometimes follow a shorter path to approval (version of a 510K process). I'm sure Insulet is still trying to squeeze by without a full-blown large-scale clinical trial. Sorry to say I wouldn't expect to see new pods until next year. The clinical trials, filing, and approval process will likely take that long. I hope I'm wrong.
This was the question burning in people’s mind and passionately talked about yesterday and today at the General Sessions of the AACE/ACE Consensus Conference on Glucose Monitoring, an event to bring together in Washington, DC all relevant stakeholders to Read on! →
If you follow the diabetes online community, you know that #MedicareCoverCGM is a big deal. We have continued to raise awareness on #MedicareCoverCGM because we believe that ALL people living with diabetes should have access to continuous glucose monitors (CGM). With Read on! →