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

Executive Summary

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.

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