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

 
• By Sue Darcey and David Filmore

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.

It's also Dexcom Inc.'s first CGM that does not require calibration by the user during its 10-day use period, measuring up to a key competitor launched last fall,

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