FDA Cites DexCom for Unapproved Design Changes in Glucose Monitors

Reuters12-11

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.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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