The FDA raised concerns with a design change to a component used in the resistance layer of Dexcom’s sensors. The sensors with the new component were less accurate than those with the original ...

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 ...

Dexcom has submitted an application for the 15-day sensor to the Food and Drug Administration for clearance. Using technology to manage Type 2 diabetes was also a focus at the conference.

Dexcom tests how well the G6 monitor sensors perform with acetaminophen and low oxygen levels, but the FDA found that the company does not have procedures in place to properly monitor and control ...

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 ...

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 ...