New Info on Gen 4 Dexcom

You need to chill out. It's not Obama's FDA but the AMA's FDA. The FDA was just as myopic under Bush and all those came before him. But yes, you are right; once again Europe and Asia are ahead of the US and we, the diabetics, suffer while the companies who make insulin and related products get rich off our backs.

Update as of Nov 2, 2011 investor report: due to a new receiver form factor, new transmitter, new frequency, new materials and manufacturing processes, the FDA has indicated that the G4 filing will be treated as a new PMA (not PMA supplement). Since it is being treated as a new PMA anyway, Dexcom decided to throw in some improvements that were were slated for Gen 5! They have already included these modifications in clinicals and have revised their estimated date of submission to FDA from end 2011 to "first part of 2012."

The 3 month or so delay in timetable seems a small price to pay for more reliability and accuracy. Let's hope it launches by end of 2012.

Some good news for Europeans; Gen4 standalone system outside-US expected launch date summer 2012.