On 3rd of march there was DexCom, Inc. Fourth Quarter 2010 Earnings Conference Call (audio here).
The news is Insulet and Dexcom made up their minds to withdraw their filing at FDA of current integrated product and integrate the Gen 4 sensor by Dexcom with second generation Omnipod (minute 14:20).
Due to omnipod 2 product plan and the trials required by FDA they plan to submit a new filing to FDA at the beginning of 2012.
The reason of this decision is due to FDA new requirements which demand more and different trials than before.
[My note: this would have required more money and delayed the product launch on the market, making omnipod first gen and seven plus an out-of-market product.]
(minute 11) Dexcom says they received CE mark (that’s European approval for device to sell) for their Gen 4 sensor for ambulatorial use, and they confirm it will launch in Europe together with Animas integrated product, now pending CE mark approval, during the first semester of this year. It’s Animas (J&J) that filed for the CE mark, so is upon Animas the decision to push for approval and reach market as soon as possible.
(minute 13:40) Dexcom tells us that Animas integrated product will be called … (sorry, listen and tell me how do you spell it, it sounds to me as “the vibe” but I’m not of english language).
(minute 34:35) As far as regards Gen 4 system by Dexcom in USA, Dexcom says FDA now consider CGM as risky devices and calls for more trials and better on the field test usages. So Dexcom will do another trial now and hopes to submit a PMA to FDA by this summer and if everything goes well the product should reach USA market at the beginning of 2012.