FDA Cites DexCom for Unapproved Design Changes in Glucose Monitors
Reuters
Dec 11, 2025
FDA Cites DexCom for Unapproved Design Changes in Glucose Monitors
DexCom Inc. is facing significant regulatory scrutiny following the receipt of a Warning Letter from the U.S. Food and Drug Administration (FDA) in March 2025. The FDA cited DexCom for non-conformities in manufacturing processes and its quality management system after inspections at the company's facilities in San Diego, California, and Mesa, Arizona. Furthermore, the FDA revealed that DexCom had altered a component in its G6 and G7 continuous glucose monitoring (CGM) products without regulatory approval, resulting in reduced accuracy of blood glucose measurements and potential health risks for patients. These regulatory findings have led to notable declines in DexCom's stock price and raised concerns regarding the safety and compliance of its flagship products.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. DexCom Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 1116357) on December 11, 2025, and is solely responsible for the information contained therein.
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