DEXCOM INC

Dexcom, Inc. is a medical device company that designs, develops, and sells continuous glucose monitoring (CGM) systems for managing diabetes and metabolic health. These systems are used by patients, caregivers, and clinicians globally. The company commercialized its first product in 2006 after receiving FDA approval. Dexcom launched its latest generation system, the Dexcom G7 Continuous Glucose Monitoring System (G7), in 2023, and the Dexcom G7 15 Day Continuous Glucose Monitoring System (G7 15 Day) in late 2025. In August 2024, Dexcom introduced Stelo, a biosensor for adults with prediabetes and Type 2 diabetes who do not use insulin, marking the first over-the-counter glucose biosensor in the U.S. The G7 system received Conformité Européenne Marking (CE Mark) approval in March 2022 and marketing authorization from the FDA in December 2022 through the 510(k) review process. The G7 is classified as a Class II integrated continuous glucose monitoring system (iCGM) by the FDA, subject to special controls for accuracy, reliability, and clinical relevance. Its technical performance, including the glucose value algorithm, communication with display and mobile devices, and compatibility with Dexcom Clarity (cloud-based reporting software), is substantially equivalent to the prior generation Dexcom G6 Continuous Glucose Monitoring Integrated System (G6). The G7 is cleared in the United States for all people with diabetes aged two years and older.