Dexcom G7 CGM System Receives FDA Clearance

FDA logo in black over a white background.

Dexcom has announced their Dexcom G7 Continuous Glucose Monitoring (CGM) system has received clearance from the US Food and Drug Administration for people with all types of diabetes aged 2 years and older.

Announced on December 8, the Dexcom G7 boasts an overall MARD of 8.2% and is billed by the company as the most covered CGM on the market.

“G7 isn’t just great for people with diabetes, it’s great for healthcare professionals as well,” said Thomas Grace, MD, a primary care physician in Findlay, Ohio, in Dexcom’s December 8 announcement. "The integration of Dexcom Clarity into the mobile app provides easy access to retrospective insights about a patient’s glycemic management during in person or telehealth appointments. With its exceptional accuracy and ease of use, I’m confident G7 will be a game changer for my patients.”

The Dexcom G7 carries over several key features from the previous generation system, including the lack of need for fingersticks, scanning, or calibration, the ability to send real-time glucose readings automatically every 5 minutes to a compatible device, and the ability to share glucose data with up to 10 followers. Within their aforementioned release, Dexcom lists notable differences between the Dexcom G7 CGM system and the previous generation G6 system. Some of these key differences are highlighted below:

  • 60% smaller, all-in-one discreet wearable, with fewer components
  • 30-minute sensor warmup
  • 12-hour grace period to replace finished sensors
  • Redesigned mobile app
  • Indicated for wear on the back of the upper arm for ages 2 years and older or the upper buttocks for ages 2-17

Further in their announcement, Dexcom noted they expect a US launch of the Dexcom G7 CGM system in early 2023. Additionally, in order to facilitate immediate access, the company will offer accessible cash pay options as the company transitions coverage availability.

“There’s a reason Dexcom has the best-selling real-time CGM on the market,” said Kevin Sayer, chairman, president and CEO of Dexcom. “For more than a decade, we’ve pioneered generation after generation of sensing technology that consistently delivers improved accuracy, reliability and a simpler user experience, giving people greater control of their diabetes.”

Find more news on the Dexcom G7 system, including a study comparing ease of uptake compared with the Dexcom G6 in older, CGM-naive patients, by clicking here!

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