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 Danielle on -
Terry, I can certainly understand that. I guess, for me, I have missed my Dex alarms as is at night. Now the Mysentry(although, I hear it is out the ying yang in regards to pricing) sounds interesting for night time protection. Now that would be something I would think of in regards to their pump/integrated system. On another note though, I just had my hands on the Roche Accu Check Combo pump(FDA just cleared it July 18th), and wow...I might jump ship from all the current pumps and go to that one when my warranty is up here shortly...and just keep my Dexcom as is(seperate unit). It has a seperate remote(like Animas), but you can do EVERYTHING off of the remote. Change basal rates, bolus, review pump settings. It is like your pump...without having to actually grab your pump. It is also color screen(remote), which is nice, too. But that is a whole different topic, sorry for going off track LOL!
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Permalink Reply by Brunetta on -
that sounds grand, wish it had a cgm. Is it described, photographed on their site? I thibk I will go check it out.
Thanks Danielle
God Bless
Brunetta
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Permalink Reply by Danielle on
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Brunetta, From the short time I had to play with it yesterday...yes it is very much like the site described. The remote itself also felt VERY sturdy(not cheap and flimsy), too. I really quite like it, and can't wait to try it early next year. I think a lot of potential users of Animas will taking a closer look at this pump because of the wireless remote. I will say, if the integrated CGMS ends up being less of a deal to me...I am feeling very swayed at the moment towards the new Combo pump.
If you have an opportunity to have a rep show you the pump, I would certainly take a look at it!! :-)
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Permalink Reply by Brunetta on
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Dannielle, I went to the website and sent a letter asking for a rep to show it to me. I gto a prompt email response today, saying that they have not "launched" the models and that they would get back with me after that event had ocurred. I was told to go to the Roche/Accu chek website to get more information ( which, incidentally is exactly where I went to to get the "contact us form" AFTER perusal of the Spirit and Aviva pumo combo)s. My supposition is that they do not have rep for Columbus , Ohio or do not intend to market it here as soon as in your area. Where do you live?
God bless,
Brunetta
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Permalink Reply by Danielle on
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I would be surprised if you did not have a Rep in your area. According to the CDE and Rep that was showing off the pump, the FDA approval came as a bit of a 'surprise', and they are NOT quite ready to actually promote it. In fact, the brochure they gave me they had to 'edit' themselves(...edit as in, they literally blacked out that it was not FDA approved, and still pending). It's actually kind of funny if you look at the brochure. One of the reps stated that the guy who originally was showing me the pump technically wasn't supposed to as he hadn't received training on it yet. I go to the BDC out here in Denver, Colorado...and she said they will be sending out pumps her shortly for trials.
She explained that Roche did not set money aside this year for trials with the new Combo pump, as they didn't expect it to receive FDA approval this quickly.
Sorry for the long explanation! However, from what I gather they are all kind of in 'scramble' mode to get the pump out there, but very few of the reps have actually received training, and new brochures etc for the product(as obvious by my 'edited' brochure I received).
I have a feeling you are being told their standard reply right now, as they simply haven't trained the reps on the new pump...and they don't have all the items to sell and promote the pump yet.
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Permalink Reply by Mountain Biker on -
Ultimately the CGM (and pump) will be integrated with your smart phone. There are a couple of technical issues predominantly around the power required to interface to a smart phone. The proprietary wireless interfaces for CGMs and pumps draw much less power than even the new Bluetooth 4 standard (which is on very few phones today).
The other issue is the mobile "app" is not a very controlled environment so it would be difficult to get it through the FDA. I'd love to have the ability to slice and dice all the data from my pump/CGM through an app on my phone someday...
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