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, ...
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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DexCom CGM Sensor Sales to Continue Despite FDA Warning LetterDexCom DXCM received a warning letter from the FDA on March 4, 2025, following inspections of its San Diego and Mesa facilities in 2024.The FDA cited deficiencies in the company’s manufacturing ...
Instead of pricking your skin multiple times per day, you continuously wear a sensor that sends ... including the Dexcom G7 or its earlier version, the Dexcom G6. What part of Medicare covers ...
If you want to learn more about parking sensors, use the table of contents to navigate. Simple, affordable and easy to install, the EKYLIN reverse backup radar system is ideal for shoppers after ...
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