- Dexcom (DXCM, Financial) receives FDA clearance for its G7 15 Day CGM system for adults, boasting 15.5 days of wear time.
- The system features best-in-class accuracy with an overall MARD of 8.0% and includes innovative features such as waterproof capability and direct Apple Watch connectivity.
- Dexcom plans to launch the G7 15 Day in the U.S. market in the second half of 2025, with clinical validation as the most accurate CGM for adults.
Dexcom Inc. (DXCM) has announced that its G7 15 Day Continuous Glucose Monitoring (CGM) System has received approval from the U.S. Food and Drug Administration (FDA) for usage by adults with diabetes. The system, which is the longest lasting and most accurate CGM system, provides an extended wear time of 15.5 days, with clinical trials showing approximately 74% of sensors lasting the full duration.
The Dexcom G7 15 Day system boasts superior accuracy, measured by a Mean Absolute Relative Difference (MARD) of 8.0%, setting a new standard in glucose monitoring technologies. The device features waterproof capabilities and allows for direct connectivity to Apple Watch, enhancing convenience by enabling users to manage diabetes hands-free.
Additional features include automated activity and medication logging, a 12-hour grace period for sensor replacement, and remote glucose sharing capabilities with caregivers. The system is expected to launch in the latter half of 2025, with Dexcom working closely with insulin pump partners to ensure compatibility with automated insulin delivery systems.
This new iteration builds on Dexcom's established reputation for innovation within the diabetes management space, offering a significant reduction in the frequency of sensor changes compared to traditional 10-day systems, thereby reducing costs and waste. Dexcom continues to reinforce its leadership position in the CGM market through these advancements.
