FDA Approves Dexcom's 15-Day Wearable Glucose Management System. Company Plans US Launch

Core Insights - The U.S. FDA has approved DexCom, Inc.'s DXCM Dexcom G7 15-Day Continuous Glucose Monitoring System for individuals over 18 with diabetes, featuring an overall Mean Absolute Relative Difference (MARD) of 8.0% [1] - The Dexcom G7 15 Day is expected to launch in the U.S. in the second half of 2025 and is designed to be compatible with automated insulin delivery systems [3] Product Features - The Dexcom G7 15 Day is the longest-lasting CGM system with a wear time of 15.5 days, allowing for easier glucose management with fewer monthly sensors and reduced waste [5] - It is the only waterproof CGM available and offers hands-free management by connecting directly to the patient's Apple Watch [5] - The system includes automated activity logging, simplified meal logging, and medication logging to help users understand the impact of activity, food, and medications on glucose levels in real time [5] - A 12-hour grace period is provided to replace finished sensors, ensuring a seamless transition between sessions [5] - The mobile app integrates with Dexcom Clarity, allowing users to view glucose patterns, trends, and statistics through interactive reports [5] - Users can remotely share glucose numbers with caregivers and loved ones for added support and peace of mind, along with enhanced and customizable alert settings for improved discretion [5]