Dexcom Gen 4 predicted FDA approval in US by end of 2012 (now available in Europe)
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.
Replies to This Discussion
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Permalink Reply by Kimberly on -
I see again that no Mac drivers are provided. It is not that difficult to create software that is compatible on any OS. I don't understand why they are basically leaving out a good segment of the Dex wearing population.
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Permalink Reply by Don on -
From what I see, this is a very worthwhile upgrade to the PLUS. It has improved low detection and I sure like the idea of a smaller receiver.
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Permalink Reply by HPNpilot on -
If you look at the their test data, the mean absolute relative difference (MARD) and the Clarke error grid numbers show they are approaching the accuracy of our strip based meters. This is good....There are, however, still a few data points in the "D" zone, which means failure to treat some highs or lows....
The improvement over the SEVEN PLUS is not that great, however... from a MARD of 16% to 14%.
Continued movement in the right direction....
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Permalink Reply by Joyce on -
Does Obama determine the time frame the FDA uses? Didn't know he was behind it.
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Permalink Reply by Brunetta on -
I am like you, Joyce.I also did not know that President Obama's powers extend to modifying the FDA approval process
. Not to get all political , Mountain Biker, but since you "went there", I will too>. Do I see a Tea Party bag a' brewing? Just sayin'.
God bless,
Brunetta
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Permalink Reply by HPNpilot on
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Honestly, what's probably made the FDA more conservative about approval of medical devices is the recent problems with other devices such as the metal joint replacements that sent metal filings throughout people's bodies and have to be replaced and devices like faulty pacemaker leads that have had to be replaced. Many people injured and millions of dollars of cost in operations to fix the problem, so they get scared and slow everything down by being more careful. I don't think the President has anything to do with it.
If you want to get political, there are a few good things for diabetics about the Affordable Care Act : we cannot be turned down for pre-existing conditions like diabetes, kids with D can be covered under there parents policies longer, the limits are removed, etc.
Try getting coverage today through an individual plan if you are not covered by a large company plan... good luck getting anyone to even offer a plan, much less at an affordable price. Many folks on here cannot get insurance and are struggling to get insulin , strips, etc. Do we condemn them to die or spend mmillions on unecessary ER care when then show up with DKA ?
I am lucky to be covered by a mega company's health plan....not everyone is...
The Congressman have a luxury government plan, however, which they don't talk about as they put down "government health care". Lets start by cutting that! Let *them* try to buy priovate insurance for their diabetic kid or spouse!
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Permalink Reply by Brunetta on
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RAH RAH!! HPN Pilot.: You said it ALL. President Obama has nothing to do with the FDA. Your exlanations of the benefits for diabetics in the Affordable Care act were both succinct and truthful.
Thanks for researching and sharing the medical equipment info, Mountain Biker: It is good to know. However,your statements about the assumed powers of the leader of our national executive branch of government,IMHO,were a tad overreactive. Tea cup too hot?God Bless,
Brunetta
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Permalink Reply by Mountain Biker on -
Just a factual correction. Obama appointed the current commissioner,Margaret A. Hamburg. Though I have zero financial connection with Dexcom (other than the money I pay them), the choice is not between no regulation and the over the top capricious regulation we have now. Just delaying the process and changes rules mid stream doesn't help.
The attached article should clear up Obama's impact on the FDA. Also note that the current private insurance in the U.S. generally pays for CGM therapy while socialized medicine in Europe does not.
http://www.whitehouse.gov/the_press_office/Weekly-Address-President...
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Permalink Reply by garidan on -
Also note that the current private insurance in the U.S. generally pays for CGM therapy while socialized medicine in Europe does not.
Not true. Here in Italy CGM is paid by Public Health Service, but it's true that few are diagnosed to need a CGM. But if you need it (hypo unawareness being first cause, or pregnancy) you pay nothing.
The same for micropumps.
I think CGM use should be wider spread, but public money is tight (I agree this) so you need to pay it for yourself as a plus.
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Permalink Reply by Mountain Biker on
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As in my prior post, Obama appointed the FDA commissioner. Margaret A. Hamburg, http://www.whitehouse.gov/the_press_office/Weekly-Address-President....
Coverage for preexisting conditions is a good thing. Much of the other 2700 pages, not so much. Obamacare needs to be replaced with a better plan that addresses some root problems -- the question is not the existing system or Obamacare, but coming up with a good market based plan. That includes reducing the costs to bring effective and safe drugs to market, not just thinging being an obstructionist makes things safer.
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