FDA Authorizes Marketing of the New Dexcom G6

DexCom, Inc., a leader in continuous glucose monitoring (CGM), announced this week that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of 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.

“As a factory-calibrated, real-time CGM system with exceptional accuracy, the Dexcom G6 will be transformative for people with diabetes, who will no longer be required to prick their fingers for diabetes management,” said Daniel DeSalvo, MD, Pediatric Endocrinologist at Texas Children’s Hospital in Houston, Texas. “I can tell you as someone who has Type 1 Diabetes myself, with all of its features and benefits, the Dexcom G6® is the CGM device I have been anticipating for the last twenty years. This CGM system will help to alleviate the burden of diabetes management while improving the lives of people with diabetes.”

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