Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...
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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 ...
Dexcom’s investigational 15-day continuous glucose monitor has a lower mean absolute relative difference than the current ...
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
DexCom, Inc. DXCM recently unveiled new data for its upcoming G7 15-day continuous glucose monitoring (CGM) sensor at the Advanced Technologies & Treatments for Diabetes (ATTD) conference 2025.
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DexCom's (DXCM) G7 CGM Coverage Expanded for Quebec ResidentsDexCom Inc. DXCM ... the back of the upper arm for up to 10 days. The Dexcom G7 CGM System is designed to be user-friendly, robust and efficient. CGM uses a wearable sensor to continuously monitor ...
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 ...
The sensors with the new component were less accurate than those with the original component, according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component ...
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