In the quarterly quarterly financial conference call, http://investor.shareholder.com/dexcom/eventdetail.cfm?eventid=117107, Dexcom Gen 4 that is now available in Europe as of June 2012 passed an audit by the FDA in July. They believe "they are still on track for approval by the FDA of Gen 4 'by the end of 2012". They said "they will be able to support the launch right after the approval". So it appears that the FDA won't withhold the benefits of the more accurate device by more than a year (which is quite good for the idiots at the FDA).
They also said they are working for pediatric trial completion by year-end.
They are also looking for "new algorithm for Gen 4 which we believe will not only further enhance performance, but enable an extended durability claim, and we will conduct clinical trials to demonstrate this claim in H1 2012". They are also working to minimize/eliminate calibration.
They are also working on Gen5 trials in Europe (since more medical research is being moved to Europe from the U.S.). On the positive side, they said the medical reimbursement for CGM from U.S. insurance companies is much better than from European medical systems.
So I take this as good news, but you never know with Obama's FDA - "withholding beneficial medical technology from the U.S. while moving medical research jobs out of the U.S.".
I'll be waiting to get a new CGM as soon as the FDA allows it.