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 ...

The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen ...

DexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the ...

The sensor is inserted underneath the skin ... Available Dexcom CGM products include: Dexcom G6 (adults and children 2 years and older) Dexcom G7 (adults and children 2 years and older) Dexcom ...

Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...

DexCom receives a warning letter from the FDA citing several issues with its popular G6 & G7 sensor manufacturing. The company response is inadequate. DexCom (NasdaqGS:DXCM) witnessed a 4% ...

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

Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note ...