Press Announcements > FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

Press Announcements > FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices

The U.S. Food and Drug Administration today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible. Continue reading.