A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

Dexcom pushed back on claims in a Food and Drug Administration warning letter that the company made unauthorized changes to its glucose sensors ... major changes to its devices without submitting ...

Dexcom’s devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors ...

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

DexCom receives a warning letter from the FDA citing several issues with its popular G6 & G7 sensor manufacturing. The ...

Dexcom, the local maker of continuous glucose monitors, received a warning letter from the Food and Drug Administration last ...

Jayson Bedford, a senior analyst at Raymond James, wrote in a March 9 research note that Dexcom said the sensors are performing as expected; the issues observed by the FDA do not impact the end ...

DexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024. The FDA cited deficiencies in the company’s manufacturing ...

At the conference, first-ever accuracy and performance data will be presented for Dexcom’s upcoming G7 15 Day system,1 ...

DexCom, Inc. (NASDAQ: DXCM), a global leader in glucose biosensing, today announced the launch of its first multi-region report, the "Dexcom State of Type 2 Report: Access and Attitudes Across ...