Navigator Update, from Tami Gamble

[rickst29]

She posted within "parents", here:
http://forums.childrenwithdiabetes.com/showthread.php?t=1694

She heard that the delay in approval is because Abbott is asking the FDA to approve as a COMPLETE REPLACEMENT for traditional bG testing... it's so accurate, you WON'T be instructed to "verify using a real meter" before you treat.

WOW.

If so, I want one: more accurate, waterproof, replaceable batteries....

[rmccully2000]

Thanks, Rick and Tamara,

That would be fantastic!

If that's true, I just wish they would get the darn thing on the market and try for replacement status afterwards. I don't know what the holdup is but some investors are now predicting October/November announcement from Abbott.

Either way, I'm tired of waiting so I'm going for the Dexcom in the meantime. We can always switch after our 3 month supply is up. Shoot, maybe I'll just wait until the Omnipod comes out with it's PDM integrated with the Navigator so I don't have to buy another receiver :) Someday.....
Becky

Oh, this makes me think of something I read recently. An investor report from HSBC (June 2006) appeared in my google alert for "abbott navigator diabetes" and it mentioned "DXCM expects to complete pivotal trial to seek replacement (vs. adjunctive) claim at the end of 2006" . I just disregarded this initially but that would make sense if Abbott were aggressively pursuing replacement status. I think it's a race to replacement!! Although the report goes on to say that the presumption is that FDA will not grant replacement at least until 2009. Here's the link to the report. It;s a very interesting read (especially since they got some of their data from the CGMS comparison chart on this website!!)

It's called Medtronic: Sizing the market for real-time continuous blood glucose monitors from MDT, DXCM, and ABT
http://www.research.hsbc.com/midas/Res/RDV?p=pdf&key=ate2b8rygn&name=127057.PDF

[rmccully2000]

Recent article with a quote from Abbott about replacement and it seems that replacement may not be holding up FDA approval after all. But good to know they will continue to try once it's approved.

"Abbott's device will be labeled for use with the current finger-stick method for tracking diabetes, Fiorentino said. The next step will be to claim a so-called "reportable result," meaning the patient won't have to verify the findings with a finger-stick test.

Abbott expects to seek that claim shortly after winning U.S. approval by using studies already in hand or soon to be completed, he said."


http://today.reuters.com/news/articleinvesting.aspx?type=governmentFilingsNews&storyID=2006-09-29T201912Z_01_N29284170_RTRIDST_0_HEALTH-ABBOTT.XML