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, ...

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

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

Dexcom, a medical device manufacturer that develops continuous glucose monitoring systems, received a warning letter from the FDA regarding manufacturing processes at its facilities in San Diego ...

The company said the letter from the Food and Drug Administration (FDA) noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators.

DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...

DexCom DXCM-1.14%decrease; red down pointing triangle received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is ...

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego ...