Animas "in the world"


I don’t know if someone here has an answer but… who knows? Maybe one of you has read or is informed about this…

Do you know why the Ping is avaiable only in U.S.A. and Canada (I think)?

each country’s medical review/approval/safety organization would need to approve it. they may require clinical trials to be done in that country, they may be willing to use the data collected in other clinical trials. but the main thing is it won’t get approved in a country unless animas asks for it to be approved.
and then it would be approved under whatever local rules and restrictions, like only available to certain portions of the population.
i work for a company that makes a [non diabetes] medication that is only available to some people in japan, based on their postal codes. and in the EU it’s available in different countries based on various differential diagnostic criteria.

Marti W tells it well. One piece of humor is some countries will accept approval of another one if it is on their list. For example, the Russian Federation will rubber stamp a US FDA approval.

Bottom line, it depends. What country?

Yes, I know. It depends on requests, approvals etc.
I don’t think the approval is more difficult for a meter+remote here in Europe.
Roche has its Accu-chek Aviva Combo, a Spirit pump + a BG meter and remote, a system similar to the Animas Ping. Many people like this feature and choose it. I don’t like the Spirit so I resisted the attraction for the meter-remote. And Omnipod is coming soon.

I’m wondering if there’s a request for approval or it’s a business choice to commercialize the Ping only in North America.

they’ll even rubber stamp a US FDA prospective recommendation. case in point this fall: the FDA review board said in advance that they were probably going to approve a medication on september 21st. so Russia approved it september 10th.

have you contacted the italian distributor/contact for animas? [although the following web address doesn’t come up for me]
Movi S.p.A.
Via Dione Cassio 15
20138 Milano, Italy
Tel: +(39) 02509051
Tech support: 800272777
Fax: +(39) 0250905247

i have no idea how to find out if a company has applied for CE certification in the EU, sorry

Thanks :wink:
I know the distributor.

No ping is coming :frowning:

Surely Dexcom integration. :slight_smile:

It also depends on money and population. It’s well worth getting things approved in the USA with a population that is, for example, about 8 times larger than Australia (Ping not available here, but the Animas 2020 is - a Ping without the meter). I’m pretty sure the Ping meter is not available here to start with.

Sometimes it’s not worth the money involved to get medical things approved, particularly if the potential for profit is low. I suspect that it’s dollars and not the altruism of companies that makes them tick. They are businesses, after all.

Animas will sell the new pump with dexcom integration in Europe before the U.S. (where now it’s more difficult to get a new product approved).
I don’t know if the new device has the remote.