Dexcom Faces US FDA Warning Amid Agency Review Of 15-Day Sensor

Warning Letter Is Temporary Setback But Unlikely To Result In Significant Market Share Loss, Analysts Say

Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.

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The FDA’s 4 March warning letter highlighted deficiencies in Dexcom’s manufacturing processes and quality management systems at two key facilities • Source: Shutterstock

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