Dexcom Inc. won an FDA de novo request for its Dexcom G6 continuous glucose monitoring (CGM) system, an upgrade from its prior G5 system, and one that eliminates the need for fingersticks. The device was approved for patients with diabetes as young as two years old, and can be used as a standalone system or with an automated insulin dosing (AID) system. Approval also means that the FDA has created standards and controls for CGM accuracy, clinical relevance, reliability, and study data requirements for CGM devices. Read More
