The clearance covers people over the age of 18 years old in the U.S. It makes the G7, Dexcom’s latest-generation CGM, the longest-lasting wearable CGM, according to the company.
San Diego–based Dexcom submitted its 15-day G7 CGM to the FDA in October 2024. The company says its 15-day G7 also meets integrated CGM (iCGM) standards from the FDA, meaning it would work with compatible insulin delivery systems.
Recently presented data at the 18th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Amsterdam showed that the 15-day CGM had an overall mean absolute relative difference (MARD) of 8%. That improves upon the existing 10-day G7’s accuracy, making it the company’s most accurate CGM offering.
“Dexcom G7 15 Day makes managing diabetes even easier with its extended wear and greater accuracy,” said Dr. Satish Garg of the Barbara Davis 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.”
More about the new, enhanced Dexcom G7
Dexcom offers an innovative, simple mobile app and the ability to share glucose numbers with caregivers and loved ones. G7 also offers enhanced, customizable alert settings for improved discretion.
With FDA clearance, Dexcom now has work underway with its insulin pump partners to ensure compatibility with automated systems. The company expects to launch the 15-day G7 in the U.S. in the second half of 2025.
“The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, Dexcom EVP and COO. “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 analysts’ take
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang maintained their “Buy” rating for Dexcom. They note that clearance marks a positive sign as the FDA granted it despite an outstanding warning letter.
The analysts also note that 15-day wear time for G7 puts it on more equal ground with the 14-day Abbott FreeStyle Libre platform. They say management expected the FDA nod around this time and planned for a gap between the approval and launch to ensure compatibility with insulin pumps. It also enables Dexcom to secure proper reimbursement coverage across multiple channels, they said.
Dexcom still needs to provide warranty for the extra five days of wear, the analysts said. They expect a more apparent margin impact in fiscal year 2026 as the 15-day CGM achieves scale.
