FDA clears Dexcom G7 15 Day CGM System
Dexcom has received permission from the Food and Drug Administration for the Dexcom G7 15 Day Continuous Glucose Monitoring System for people over the age of 18 years old and older with diabetes in the United States.
With an overall MARD of 8.0%, Dexcom G7 15 Day builds on the performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range, the company noted.
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“The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, executive vice president and chief operating officer at Dexcom. “By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology. This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing. We look forward to bringing it to market in the second half of this year, but in the meantime, we encourage our users to upgrade to our current G7 system to gain the benefits of the most connected CGM brand in the world.”
The company offered the following features of the Dexcom G7 15 Day:
- Longest lasting CGM system with 15.5 days of wear.
- Best-in-class accuracy with an overall MARD of 8%.
- Easier glucose management with fewer monthly sensors and reduced monthly waste.
- Dexcom G7 features included with Dexcom G7 15 Day.
- The only waterproof CGM available, keeping you more connected.
- Manage diabetes, hands-free. Connect your sensor directly to your Apple Watch so you can leave your iPhone behind and still see your glucose numbers.
- Automated activity logging, simplified meal logging and new medication logging help you better understand how activity, food and medications impact your glucose in real time.
- 12-hour grace period to replace finished sensors for a more seamless transition between sessions.
- Innovative and simple mobile app with Dexcom Clarity integration to easily view glucose patterns, trends and statistics via a range of interactive reports.
- Ability to remotely share glucose numbers with caregivers and loved ones for added support and peace of mind.
- Enhanced and customizable alert settings for improved discretion.
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“Dexcom G7 15 Day makes managing diabetes even easier with its extended wear and greater accuracy,” said Satish Garg, MD, from Barbara David Center for Diabetes at the University of Colorado School of Medicine. “Data recently released during the 18th international Advanced Technologies and Treatments for Diabetes conference in Amsterdam supports that G7 15 Day is the most accurate CGM for adults.”
Dexcom shared that it is working closely with its insulin pump partners to ensure that Dexcom G7 15 Day will be compatible with automated insulin delivery systems upon launch. Dexcom G7 15 Day is expected to launch in the United States in the second half of 2025.