The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
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 made a significant design change to a component used in its sensors and did not adequately validate the change, ...
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DXCM Stock Falls as FDA Warnings Raise Concern for 15-Day G7 ApprovalDexCom DXCM is facing regulatory scrutiny following a warning letter recently posted by the FDA. This could affect the ...
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 ...
Biosensors are devices used to detect the presence or concentration of a biological analyte, such as a biomolecule, a biological structure or a microorganism. Biosensors consist of three parts: a ...
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