Dexcom extends G7 sensor wear time to 15 days with latest FDA nod

Title

Dexcom Receives FDA Approval for G7 CGM Sensor with Extended 15-Day Wear Time

Keywords

Dexcom G7, FDA clearance, continuous glucose monitoring (CGM), 15-day sensor, diabetes management, MARD accuracy, wearable technology, extended wear time, glucose monitoring, diabetes innovation.

Key Facts

- FDA Clearance:
The Dexcom G7 Continuous Glucose Monitoring (CGM) system has been approved by the FDA for a wear time of up to 15 days, including a 12-hour grace period for sensor replacement1 2.

- Extended Wear Time:
The 15-day version increases sensor wear time by 50% compared to the previous 10-day G7 model, reducing the frequency of replacements and overall waste1 3.

- Improved Accuracy:
The new G7 15-Day CGM has an improved Mean Absolute Relative Difference (MARD) of 8.0%, slightly more accurate than the previous model (8.2%), making it the most accurate CGM available for adult users1 2 4.

- Waterproof and Versatile:
The device is waterproof and features compatibility with Apple Watch, automated activity and medication logging, simplified meal logging, and customizable alerts1 4 5.

- User Compatibility:
The new system is approved for adults aged 18 and older with type 1 or type 2 diabetes but is not yet available for pediatric patients. Dexcom plans to launch the product commercially in the latter half of 20255 10.

- Clinical Testing:
Studies demonstrated the G7 15 Day meets performance standards for integrated continuous glucose monitoring (iCGM), supporting its integration with insulin delivery systems like the Omnipod 51 8 10.

- Environmental Benefits:
The extended wear duration reduces sensor changes and therefore minimizes waste, appealing to environmentally conscious consumers2 4.

- Market Impact:
Dexcom's innovation solidifies its leadership in CGM technology, boosting its reputation and potentially influencing share value positively5 8.