Looks like our dear US Gov’t is way behind in its approval process. I cannot find the specifics but VIBE (an Animas Ping with a Dexcom 4G sensor system built in) has been available in Europe for many months and the Ping remote with a much easier to see COLOR screen has been available in Canada for many months also.
What is happening to our FDA (fear defies all)? Are they full of fear? Are they trying to kill America’s medical machine and drive it off-shore?
All TD users need to keep a close eye on FDA and verify they are moving with due diligence!
The Animas Vibe looks so cool!! I can’t wait until they approve it!!
I think it’s good that they make sure stuff is safe before they release it. But I definitely hope this is available soon!
I think it’s pretty neat. I don’t wear a CGM and I don’t know that I’m completely sold on them, but the one with the Vibe seems to suggest it’s a decent one. I definitely would be willing to try the pump itself.
The VIbe was rolled out at the American Diabetes Association meeting last June. I posted on it at that time - the text of the post follows:
“I just returned from the American Diabetes Association (ADA) annual meeting in San Diego. Lots of interesting material, and I am still digesting most of the clinical presentations that I attended On the exhibit floor, and of particular interest to this group, was the fact that ,as noted previously, the new Gen 4 probe from Dexcom is now approved in the EU. Both Dexcom and Animas were showing the new Vibe pump. It is essentially an upgraded Ping with a color screen and with the Dexcom CGMS fully integrated. I had an opportunity to play with it, and compared it to my Ping. The Vibe was significantly faster than the Ping when I scrolled up a 10 unit bolus, so once available, it should actually work better and not just look better.
The Vibe has been approved in the UK, but has not yet been launched there. It has not been filed to the FDA yet, and the most that I could learn is that some of the booth staff were hoping for a filing before the end of the year. It was quite apparent, however, that this was purely aspirational on the part of those people I spoke with. Animas has no official projection as to when it will be filed. One should not expect to have the Vibe approved in the US for at least 18 months (my personal best estimate). I also got a chance to see the new Ping 1.5 meter that is available in Canada – this is the one with the nice color screen.”
The issue is not that the FDA is not being diligent, but that at the time, Animas had not even filed the device with the FDA. The agency cannot approve somwething that they are unable to reivew.
According to Animas customer support, the product is at FDA and they are asking for a repeat of even finger stick technology to be repeated. Sounds to me like FDA is being petty.
Hmmm, the 3 people at Animas that I spoke with over the last week said that it wasn’t even submitted to the FDA yet. I’ve been a Minimed 722 with CGMS for the past 4 years, but went with the Ping anyway given their intent to have an integrated system (with Dexcom). Like everyone else, I have been less than impressed with Minimed’s accuracy, but it’s helped me get better A1c’s nonetheless. Some info is better than none.
Hi Jay
I asked the same question before why it take the goverment and the FDA a long time to past things that will help the American people with health issues . What I think it is its not them that need these thing to stay a life and try to live a normal life with a health issue . But we all have to stick all together and continue with what we have .
I try to not let new things push me into a frenzie. I want it as bad as the next but when I seem to just be content with what I have which is the Ping I go much better and the waiting time is much less b/c some day I just get plesantly surprised with “it’s out” :o) I currently wear both the Ping and the Dex and it’s not as much of a bother as I thought it would be. Good luck and 18 months is nothing on a global scale.
When I called Animas a few weeks ago they said they think the Vibe will be out by January when my warranty is up. I don’t think it’ll happen that quickly though. If you google Animas Vibe, you can find it on the European version of the website and I even downloaded the user manual to see how it works & stuff. I almost started on a Dexcom last year, and then the Dexcom people had said that each time they come out with a new model the entire process has to be tested again before approval.
I guess that when the time is right Animas will provide what ever is needed for the Vibe to be approved by FDA. Until then we handle our diabetes the best way we all know how. It would be beneficial for alot of pump users to get this done now not later.
But time will tell.
Just like FDA. Now that the finger stick issue is handled, they are going after Dexcom's 4th Generation System again. This has stalled the VIBE. The US should be like some other G7 countries, if one approves the device, it is approved in the other country upon presentation of the first approval.
