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 ...
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
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