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 ...
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DXCM Stock Gains Following New Data on Upcoming G7 CGM SensorDexCom, 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. With ...
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and ...
Dexcom’s investigational 15-day continuous glucose monitor has a lower mean absolute relative difference than the current ...
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 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 ...
Insulet (PODD) announced its revolutionary Omnipod 5 Automated Insulin Delivery System is now available in Australia and will soon be offered ...
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 ...
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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