FDA Clears Eversense 365: First One-Year CGM Sensor

On September 17, 2024, Senseonics Holdings, Inc., in collaboration with Ascensia Diabetes Care, announced that the U.S. Food and Drug Administration (FDA) has cleared the Eversense 365 Continuous Glucose Monitoring system.

This is the world’s first CGM with a sensor that lasts an entire year!

What makes Eversense 365 unique?

Traditional CGMs require sensor changes every 10–14 days. Eversense 365 requires only one sensor insertion per year.

This reduces interruptions, simplifies diabetes care, and allows you to focus on living your life instead of constantly managing your condition.

Key benefits

• Longest-lasting CGM: Only one sensor insertion per year!
• Reliable performance: Reduces risks of data interruptions often seen with shorter-term CGMs.
• Trusted accuracy: Alerts you to highs or lows with minimal false alarms, especially at night.
• Improved comfort: Gentle adhesive minimizes skin irritation, and the removable transmitter offers flexibility.
• Discreet alerts: Vibrations notify you of important updates, even without your phone nearby.

Eversense 365 has also been cleared as an integrated CGM (iCGM). This means it can connect with insulin pumps as part of automated insulin delivery (AID) systems.

What’s next?

Senseonics and Ascensia are working on exciting partnerships to expand the integration capabilities of this system, ensuring even more seamless diabetes care in the future.