So what is the straight scoop on the Animas Vibe clearing FDA approval process?

Could someone in the know explain exactly what stage/step the Animas Vibe is at and what that means in terms of a likely release date? I can’t believe it has taken this long for approval of a system that is already in use around the world. This system represents the same technology already in use in America (Ping and Dexcom) and the concept of integrating the two has already been accepted in America (Minimed). How long does it take to test a unit already in use throughout the world?

FDA…get your act together and stop holding this system hostage…

I'm interested in the Vibe as well. I have an Animas Ping with the warranty expiring in October 2012 and a Dexcom Seven Plus that can be replaced in August 2012. I definitely don't want to replace both units if I can get them combined with the Vibe.

I've tried getting information from the U.S. division of Animas with absolutely no luck.

This past spring I took a different approach and contacted someone from Animas in the U.K. because the Vibe has been available there for some time already. The person I contacted said the FDA application for the Vibe wouldn't happened until June of this year. Then the FDA has to review the application and all the data. They may request additional information, additional studies, etc. before giving their approval. I was told the best case senario for approval would be first quarter of 2013.

Based on this, I'm hoping for the best case since the Vibe has been selling in Europe for a while. I've decided to wait until I can get the Vibe rather than replacing my existing pump and Dexcom with the same units. Hopefully both my existing units will cooperate with my plan.

You got it, FDA. The last time I asked I was told it's in the final stage for approval. Soon. Same answer for, what, at least a year? Totally frustrating.

I also have the Ping, was told that upgrade to the Vibe would be cheap if I moved from the 2020 to the Ping. That was when the Vibe was to be to market in the 1st quarter 2012! So, now the Ping I have is out of warranty, and the Vibe maybe available in 2013…errrrr

What I have heard from some employees of JNJ and Dexcom speaking off the record is Animas must wait for Dexcom to get FDA approval for the fourth generation sensor system before launching an integrated system using the Dexcom 4G.

Of interest, if my pump is out of warranty and I am in the EU, my insurance carrier would pay for a Vibe if I played the health care game abroad. The bite would be getting supplies here in the states. Go figure.

Really? We could do that? How would it be possible? And once gotten how would we get supplies? So we could technically go on vacation to EU and get one covered by insurance ? I thought most US insurance companies only cover health treatment provided if true emergency occured