Sorry if this is old new/previously posted.
Dexcom’s Q2 2010 Earnings Call Transcript is up on Seeking Alpha.
Feel free to surf over and read the whole thing or not. My quick read
was looking for information about pump integration and there was
confirmation the the OmniPod/Dexcom product was into the FDA for review
and that the Animas supplemental FDA filing was expected by year end.
Shifting to our insulin pump partnerships, as we mentioned on our last earning call, we have filed a PMA supplement with the Food & Drug Administration for our first generation integrated systemThey also shared the information the next generation (Gen 4) was into the FDA and some of the possible features of Gen 4 that
with Insulet Corporation and we are currently awaiting feedback from
the agency. Additionally, we have completed development and are in
final testing with respect to a modified transmitter for use in our
integrated system with Animas and we remain committed to filing a PMA
supplement for the combined DexCom Animas system before the end of the
are of interest patients. May being the operative word, these are
forward looking statements:
I'm pleased to report that we have filed a PMA supplement Gen4 with the Food and Drug Administration.
... our goal with Gen4 is to bring to market a next generation sensor which will offer an unmatched level of performance and ease of use for
our patients. Our Gen4 Sensor is more accurate than any of our previous
sensor systems particularly in the hypoglycemia range. Gen4 will also
have a one hour warm up time... We believe that performance of Gen4
may in the future allow us to submit through the FDA for an expansion
of our labeled indications for use.
For example, the Gen4 sensor may permit a reduction in required calibrations points during a sensor session it may also enable us to
obtain an indicated sensor light of longer than seven days. We expect to
explore the requirements for obtaining these expanded indications with
FDA and conduct clinical trial work later this year. Additionally, we
are in the final stages of development of a new receiver form factor
and a new transmitter, and we expect to file with the FDA later this
year to incorporate those components into the Gen4 system.