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.

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, Abbott Diabetes Care Inc.'s Freestyle Libre Flash CMG device

More from Diabetic Care

More from Device Area

Digital Health And AI Tools Advance Cardiac Event Prediction, SCAI 2025 Data Show

 
• By 

Out-of-hospital cardiac arrest remains one of the most challenging and resource-intensive emergencies in cardiovascular care. At SCAI 2025, clinicians presented a novel algorithm that improved triage decisions and reduced unnecessary interventions.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By 

Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.