FDA Warns DexCom Over Unapproved Sensor Changes in G6 and G7 Devices
DexCom, Inc. DXCM | 62.37 62.37 | -0.68% 0.00% Pre |
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.
