Dexcom has received FDA clearance for its G7 15-Day continuous glucose monitoring (CGM) system for people 18 and older with type 1, type 2, and gestational diabetes. The company plans to launch the new system in the second half of 2025.

The enhanced system extends wearability to 15.5 days, including a 12-hour grace period, representing a 15% duration improvement over the standard G7 model. Users benefit from uninterrupted glucose data transmission to the Dexcom G7 app or receiver every five minutes without requiring traditional fingerstick tests or manual scanning. According to Dexcom, the system achieves an overall mean absolute relative difference (MARD) of 8.0%, a key parameter used to measure the accuracy of CGM systems as defined by the NIH National Library of Medicine.

The G7 15 Day maintains the waterproof, hands-free design of previous iterations while expanding connectivity options, including direct Apple Watch integration. Additional functionalities include automated activity tracking capabilities that enable users to record meals and medication administration for more comprehensive health monitoring. For data management, the system works with the Dexcom Clarity mobile app, compatible with smartphones and computers, providing glucose patterns and statistics while enabling users to share their glucose data with caregivers and family members. Dexcom is also working with insulin pump partners to ensure the G7 15 Day will be compatible with automated insulin delivery systems.

"The approval of Dexcom G7 15 Day marks another major innovation for Dexcom," Jake Leach, executive vice president and chief operating officer at Dexcom, said in a press release. "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."

This regulatory milestone furthers Dexcom's strategic positioning in the competitive glucose monitoring sector. In March, the company established a licensing and data partnership with digital diagnostics company Nanowear to integrate glucose data from the Dexcom G7 into Nanowear's SimpleSense nanotechnology-enabled cardiometabolic wearable. Earlier in 2024, Dexcom made a $75 million strategic investment in health-tracking ring maker Oura, establishing a partnership enabling bidirectional data exchange between Dexcom's CGM and the Oura Ring. The investment contributed to Oura's Series D funding round, which valued the company at more than $5 billion.

Other competitors in the CGM space include Abbott, which in 2024 announced its CGM system Lingo could be purchased in the U.S. without a prescription, and Medtronic, which received FDA clearance for its Simplera CGM, a disposable, all-in-one system that is half the size of previous Medtronic CGMs.

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