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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

 
• By Shubham Singh

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.

FDA_Warning
The FDA’s 4 March warning letter highlighted deficiencies in Dexcom’s manufacturing processes and quality management systems at two key facilities • Source: Shutterstock
Key Takeaways
  • Dexcom received an FDA warning letter citing deficiencies in its manufacturing processes and quality management systems at facilities in San Diego, CA, and Mesa, AZ.

As Dexcom awaits FDA approval for its 15-day sensor, the company has encountered a regulatory hurdle: a warning letter from the US FDA citing deficiencies in Dexcom’s manufacturing processes and quality management systems following inspections at its facilities in San Diego, CA, and Mesa, AZ.

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