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There's a press release on 11 april (link) which states:
Ypsomed will become the exclusive distributor of the OmniPod insulin pump in a total of 22 countries, including several additional countries in Europe, the Middle East, and Asia.
"We have recently sent Ypsomed their initial shipment of the next generation OmniPod for sale in Europe where it has CE Mark clearance...."
I'm wondering if anybody as an insiders view and can tell which are these countries ?
Here in Italy we are waiting omnipod from so long ....
OK so consider: Insulet needs to sell omnipod 2, they are producing 300000 pod/month and Europe doesn't need them all.
They lost money every year since foundation, and the new pod costs 30% less to them to produce.
So they need it: if it's not approved by FDA these months, Insulet is no more.
That would make me so angry, can we do anything to lobby the FDA into speeding up this process. We've all known about the second generation for years. Its horrible that they can prolong an upgrade to a product so long that the company can go under just from waiting. We have been very happy with the Omnipod and Insulet as a company,(They replaced a PDM that was damaged in son's backpack... hard case now), they need to be contender with the other pump manufacturers. The features only Omnipod offers were just what made "D" life easier for my son.
Dreamers 1 realists 0
FDA yesterday cleared Omnipod next gen.
Everybody wins ;-)
Been using the new Omnipods for a few weeks now and very impressed. Only time will tell for reliability but no issues with filling/priming/starting so far.
The new pods really are noticeably smaller and are definitely easier to get a wetsuit over - the adhesive seems to hold up better after prolonged immersion too. Reduced mass of the pods was also noticeable for the first couple of days, particularly when running and cycling on rough terrain. Coloured canula is also a nice touch and makes it far easier to check for problems.
Only downside so far is that they're way harder to get into; probably not an issue for most but I like to break 'em apart for recycling - needle & canula in sharps bin of course.
As for the PDM, physically there's no change other than the colour; it's now black. As for firmware, the only changes I've spotted so far are:
1. ID confirmation prompt at waking: when waking from sleep the PDM asks you to confirm that you're you - you have to give the PDM an ID at setup to facilitate this. I guess this is to avoid inadvertent swapping of PDMs if there's a gaggle of podders around.
2. Additional extended bolus options; think I spotted something about this in the manual but may be wrong. Will check again.
As for other features/changes, the blister packs are slimmer thus making it easier to carry spares. Also, filling needles are MUCH shorter to accommodate the thinner form of the pods.
That's all I can think of for now but I'm happy to answer question from anyone that's interested.
If we all wait a year or two we will be able to switch to the SOLO micropump.
What is the SOLO - i still love the "Pancreum" model
2 years ago Roche aquired an Israel-based Medingo company which had developed and FDA approved a patch pump (link diabetesmine).
We are still waiting ..... they say late 2012 in small quantities in Europe
we are planning a limited launch in the Netherlands and Germany in the second half of 2012 with a U.S. launch to follow
pancreum is only a design, nothing real
Pancreum is more than just a "design" or "concept". The electronics/software prototype is ready and functional, including an feature-rich Android app that controls the system via Bluetooth.
However, the pumping/insertion mechanisms still are in the engineering stage and it will be a few years before it is released. We're still negotiating with V. C. firms for proper funding and still have to go through clinical trials and the FDA/CE Mark/etc approval process.
Which electronics is ready ? The remote ? The hard part is the pump, do you manifacture it or reuse something made by others?
1. The remote is a commercial PDA or smartphone (Android or iPhone/iPod Touch). The app in Android version is ready.
2. The electronic that is ready, is for the reusable wearable device "CoreMD" (2 microprocessors, a rechargeable battery - via micro USB - and the Bluetooth circuitry.
3. We will manufacture our own pumping "wedge" (reservoir and pumping & insertion mechanisms). The patent has been filed, the design is under way.
4. We will also manufacture our own glucose monitoring "wedge" (sensor & its automatic insertion mechanism), but the needle-shaped sensor itself will be from a 3rd-party company.
We are former Insulet, Medtronic and Bayer (software, electronic, mecahnical, manufacturing) engineers.
But as I said, still a few years away from releasing anything.
I'll report back in my italian forum your news.
Keep working on it !