FDA Warns DexCom Over Unapproved Sensor Changes in G6 and G7 Devices

Reuters12-16

FDA Warns DexCom Over Unapproved Sensor Changes in G6 and G7 Devices

DexCom Inc. is facing regulatory scrutiny after receiving a Warning Letter from the U.S. Food and Drug Administration (FDA) in March 2025, following inspections at its San Diego and Mesa facilities. The FDA found non-conformities in DexCom's manufacturing processes and quality management system. Additionally, the FDA revealed that DexCom had made an unapproved change to a component in its G6 and G7 continuous glucose monitoring devices, resulting in less accurate blood glucose readings and potential health risks for patients. These regulatory actions have led to significant declines in DexCom's stock price and may impact the company's operations and reputation.

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: 1117874) on December 16, 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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