A company spokesperson said Dexcom plans to resolve the agency's concerns but stated no design changes were made to its ...
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
Dexcom pushed back on claims in a Food and Drug Administration warning letter that the company made unauthorized changes to its glucose sensors ... major changes to its devices without submitting ...
Dexcom’s devices were misbranded because the company did not submit a premarket notification to the FDA before making major changes to the sensors, according to the warning letter. The sensors ...
The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...
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DXCM Stock Falls as FDA Warnings Raise Concern for 15-Day G7 ApprovalDexCom receives a warning letter from the FDA citing several issues with its popular G6 & G7 sensor manufacturing. The ...
The FDA has cleared Dexcom’s Stelo as the first continuous glucose monitoring (CGM) device that does not need ... for one two-week sensor and £300 for four. There are more than 25 million ...
A study that looks into the potential of wearables to non-invasively measure blood glucose has come up with promising results ...
CGMs are transforming health tracking for non-diabetics, providing insights into glucose levels and influencing dietary choices and athletic performance.
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