The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
Dexcom launched ... in the U.S. Glucose is a type of sugar people receive from food, and it's the body's main source of ...
The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen ...
To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Dexcom is preparing to launch a 15-day version of its G7 continuous glucose monitor, based on data ...
If you have diabetes, a continuous glucose monitor (CGM ... Medicare Part B should cover several types of CGMs, including the Dexcom G7 or its earlier version, the Dexcom G6.