Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

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 ...

while planning to expand the production of its G6 and G7 diabetes blood sugar trackers in the greater Phoenix area. The new admonition came after the FDA found deficiencies in Dexcom’s response ...