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.

US FDA has approved the Dexcom G6 iCGM system, the first type of continuous glucose monitor for diabetics that can be part of an integrated system with other compatible insulin dosing systems, insulin pumps or blood glucose meters.

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