Here is a way over simplified overview of what I get: The FDA came back to Dexcom and is requesting more data. There is quite a bit of candid conversation in that call. About CGM pump integration and about the FDA looking at insulin pumps with a more heightened scrutiny.
Attempting to translate the call into the simple what does it mean for my pumper language for families living diabetes it comes down to this; CGM integration into OminPod and Animas pumping systems is at pushed back. Taking a SWAG maybe a half year, probably more. This looks to be in part about CGMs and part about tighter regulation of insulin pumps.
Insulin pump companies today are faced with the likely prospect of having their pump products regulated under a new subset of class two devices where approval standards are in a state of flux and human clinical data requirements are unclear.
the FDA is undergoing sweeping changes to its review and approval policies and procedures, and has set forth as a priority an effort to improve the level of regulatory science the agency applies to all medical devices to better assess, evaluate, and review products.With regard to Generation 4 of the Dexcom system which is what Animas is looking to work with:
we (Dexcom) expect to complete a small additional clinical trial with the Gen4 sensor paired with our next-generation receiver and transmitter, and file an amendment to our Gen4 PMA supplement during the first half of next year. Although we cannot predict the ultimate decision or timing for a decision by the FDA, we believe this amended Gen4 submission will be incorporated into the current Gen4 180-day review cycle, give or take a few months.OmniPod has some decisions to make about how to proceed. They were expected to launch before Animas based on using the current generation 3 Dexcom product. However the FDA seeking more information means OmniPod may want to look to Gen 4
Insulet, as you'll recall, is paired with the SEVEN Plus. The Animas product, when complete and filed, will be paired the Gen4 sensor.
The Insulet situation's a bit more difficult to describe, only from the standpoint that Insulet's got to make some decisions as to what they want to do going forward, either to move forward with the SEVEN Plus, or if they make the decision to go to Gen4While there is additional scrutiny in the USA the EU combined Animas/Dexcom system continues to be expected in the first half of 2011.
we remain committed to filing for CE mark approval before the end of this year and expect to be in a position to launch the combination product in Europe during the first half of next year.
In closing my post, I thought this was a particularly telling comment in that I think every patient, parent and partner of a pumper is accurately aware of the seriousness of this statement:
I've long said it amazed me that the pumps were 510(k) products that carry around anywhere from 180 to 300 units of insulin, which is a potentially lethal amount of insulin.As a parent of type 1 kids I don't take that lightly at all. We accept that as a means to a living more normal, better manages lives. The point of all this technology is to make diabetes secondary to living pseudo normal lifes and pursuing dreams.