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 ...

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

Continuous glucose monitors (CGMs) are monitoring devices people with diabetes use. They apply them directly to the skin and monitor their blood glucose (blood sugar) readings in real time.

The study enrolled 319 people in a randomized controlled trial. Tandem found that people who used its Control-IQ+ algorithm ...

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

Dexcom (Nadsaq:DXCM) today announced new insulin delivery integrations and updates on enhanced continuous glucose monitors ...

Insulet Corporation PODD recently made its Omnipod 5 Automated Insulin Delivery (“AID”) System commercially available in Australia. Omnipod 5 is available with Dexcom G6 and G7 continuous ...

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. A warning letter posted Tuesday by the Food and Drug ...