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 ...
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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 ...
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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Dexcom vs. FreeStyle Libre: What to Know About These CGMsThe sensor is inserted underneath the skin ... Available Dexcom CGM products include: Dexcom G6 (adults and children 2 years and older) Dexcom G7 (adults and children 2 years and older) Dexcom ...
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 ...
Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie Marcus wrote in a research note ...
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