I keep hearing that the pod is getting smaller and thinner , that omnipod is waiting for FDA approval which should happen WHEN?? does anyone have any information about this…
The last I heard w/ the 3rd Quarter conference call that Insulet posted on their Web site, the pods are not scheduled to be out until 2012 at some point. They had recently received CE Mark approval (the European version of FDA clearance) so production of the pods for over there should begin later this year…which means they will follow suit over here at some point. Last speculation was a spring 2012 rollout, but I wouldn’t be surprised if that is pushed to the middle of 2012.
If you hear about something like that, either with the new pod, the new animas pump or sensors, always figure atleast a year until it happens. The FDA approval process is very very slow. They have to complete the trials to show non-inferiority over the previous version, then analyze the data and then submit it to the FDA. For biologics, I don’t know if it’s the same for devices, they have to wait to be granted a PDUFA date, when the FDA will look at it and then the FDA has (I think) something like 6 months from then to decide. So it easily could be a year of more from time for FDA submission to approval.
Thank-you for your response it gives me a target time or base line of when to expect something to happen.
Every time I have a date fixed in my mind I get disappointed so I have decided it (ANY of the new pumps) will be here when they are here. Not sure it is very effective in decreasing my frustration over the silliness at the FDA though
I too feel that same frustration, I guess it is not something we have control over…
I always wonder what does happen if a CE mark approved device is asked by FDA to change something, in its software or hardware?
Has the firm to manifacture two different versions of the product ?
I think its a stupid thing and expensive.
FDA and CE should agree a common protocol and avoid to do things twice and differently: our safety standards in Europe are not so different from USA ones.
any more news about new omnipods, my doctor just mention she doesn't know why it is taking so long because it works the same way nothing different> except the size...
The last I heard from a friend who works as a pump trainer for Omnipod was that the release date is sometime in Dec 2012 for US and early-mid 2013 in Canada. (but she readily admits that she in not so much in the loop just b/c she works for them)
thanks I guess we know it's coming I hope
Last I heard, the FDA is the hold-up. The FDA recently decided that all medical devices would receive much more scrutiny than they have in the past. This means that the route Insulet would have taken (basically just saying that the new pod is the same as the old pod, not a new device, which would just need some paperwork/data) is no longer available. I believe they had to go through a much longer process and the FDA is being painfully slow about approval of all medical devices.
Therefore, nobody has a clue because it's easier to predict winning on a slot machine than to predict when the FDA will approve something.
I believe these new pods have been in the FDA process since 2010.
I believe it has been since then I was aware of it , I'm just keeping my fingers crossed!!!