March 6, 2009

Dexcom FDA approval - Question is for What?

So this little gem is all over the wires today:

March 5 - DexCom Inc: Says received approval from FDA for third generation continuous glucose monitoring system on February 13 - SEC filing * Says to begin commercializing product in Q1 2009

Anyone paying close enough attention to know what this is?

**Edited to ad**

(After using Google apparently I know. It was the first hit. LOL I just don't know I know, ya know what that is like?)

I quoted Trey Gregg - Dex CEO from Seeking alpha:

We are also pleased to report that we have filed a PMA supplement for a third generation continuous glucose monitoring system with the Food and Drug Administration. Data from our approval support trial demonstrated significant improvements in system on time and improved accuracy as compared to our current product. In addition our third generation system will include twin doors to complement our turn graph and event entry capabilities such insulin intake, (inaudible) exercise as well as configurable alarms.

Diatribe put that into actual english

As we understand it, DexCom is close to a third generation sensor - it has completed the necessary clinical trials necessary for FDA approval. Advantages of this system include a 75 percent smaller sensor size - allows for a smaller insertion unit, which is potentially less painful. The other major promised improvement is in the software component of the device; this version of the software will have trend arrows; event markers for food, exercise, and medication dosing; and user-adjustable alerts with different sounds associated with hyperglycemia and hypoglycemia.

1 comment :

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