Dexcom is pleased to announce 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.
Dexcom is pleased to announce the Food and Drug Administration (FDA) approval of the Dexcom G5 mobile app for Android devices. Beginning in June, Android users will have access to the free app for the Dexcom G5 Mobile CGM System, allowing people with diabetes to view and monitor their glucose levels on their mobile devices to manage their diabetes in real time. The Dexcom G5 Mobile CGM System is the first and only CGM platform available for Android in the United States, complementing the 2015 iOS launch.
Dexcom is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicare who have either Type 1 or Type 2 diabetes and intensively manage their insulin will now be able to obtain reimbursement.
