Dexcom: FDA Warning Letter States Company Made Changes to Continuous Glucose Monitors Without Necessary Approval from Agency; Letter States Company Commits to Ceasing Distribution of Sensors with Design Changes that Caused ‘Higher Risks for Users’

Published on Mar 25, 2025

The FDA has published a warning letter it sent to Dexcom (DXCM) earlier this month regarding issues with the manufacturing and validation of its continuous glucose monitors (CGMs) that affected their accuracy. The warning letter states that Dexcom failed to gain necessary approvals for the design changes to its glucose sensors, which the company knew […]

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