The Dexcom G6 continuous glucose monitoring (CGM) system received FDA marketing approval March 27, the agency announced.   

This is the first system permitted by the FDA to be used in an “integrated” fashion alongside other diabetes management devices, including automatic insulin dosing systems, insulin pumps and blood glucose meters. The FDA said such systems would be classified as moderate risk class II medical devices, paving the way for similar integrated products to make it to market in “the least burdensome manner possible.” Previously, continuous glucose monitoring systems were reviewed based on more rigorous criteria for the highest risk, class III medical devices.

“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”