"On a conference call with analysts Thursday, the
said the U.S. Food and Drug Administration had requested more
data as well some clinical trials to support the approval of
its Gen4 sensor, integrated insulin pumps and an intensive care
The FDA has been receiving a lot of criticism lately regarding regulation of medical devices (or lack of) after a report came out in the British Medical Journal about potential deaths related to an FDA approved vagus nerve stimulator to treat depression. The call for more data and clinical trials by Dexcom may be a result of that.
Stocks dropped 29%
For those that don’t know the conference call from Nov 4 is posted on dexcom’s website. I listened to it last night. Most definately delays with everything including Gen 4, and integration with Animas and Omnipod. I haven’t been following the development of a hospital based sensor.
My thought exactly!
Anyone know where I can sign up for a clinical trial?
I am now an owner!