Dexcom Gains Approval For No-Calibration, 'Interoperable' CGM System

US FDA's March 27 de novo clearance of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for diabetics gives Dexcom a no-calibration offering, a first-in-class "interoperable" system and sets out a streamlined regulatory pathway for future CGM devices with similar features.