The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback