FDA approves G6 continuous glucose monitor for diabetes mesurement.- Dexcom

Dexcom announces that the FDA has granted a De Novo request for the Dexcom G6 CGM System, the newest generation of Continuous Glucose Monotoring (CGM( for people with diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6 is the first CGM to receive this classification by the FDA.

Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring CGM accuracy, reliability and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable CGM performance.