Anyone knows when the Animas Vibe will be approved by the FDA and released? I’m tired of waiting!!!
Should be anytime time now since it was sent to the fda about 6 months ago.
The government shut down has surely set that back. Remember, the FDA was told to stay home.
My understanding is that Accuchek, Omnipod, Tanden, and now Medtronic have all taken 12 to 18 months to get through the FDA under the new guidelines. The only company that received anything faster was Dexcom. So we may still have a bit of time to wait yet.
I wrote down the Vibe submission for FDA clearance on my calendar. It happened on April 15, 2013. We now stand at six months and two weeks. Tick-Tock...
I don't know how legit this is or if it will do any good but I felt good signing it :)
Cheers!
“Shifting to our integration partnerships, Animas continues to work with the FDA on its PMA submission seeking approval of Animas 5 system in the U.S. Animas is currently completing additional verification and validation testing and additional human factors testing requested by the FDA and expected to have all additional testing done in response to submitted to the FDA by the end of January.”
Animas rep at local conference said April…not encouraging.
I agree - it is getting old.... Why does our FDA take so long to approve things?????
I have been hearing that it was around the corner for almost three years now. I wonder how many pumps they sold on this empty promise. I really don't see it being that difficult nor do I see the linking it with the current smart phones out of the ordinary. Dexcom is supposedly working on it but they still do not have a software package that works with a Mac. The only company that has shown true creativity in my mind is Tandem and as such they will be my next pump. I sat in on a users group about three years ago in Austria and listened to the great minds present talk about the desire to have control of a pump on a phone or the ability to read a CGM sensor on the phone not desired by most users. In my opinion they could not have been farther from the truth. They sited software form the phine manufacturers as being to volatile, I disagree.