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Home » FDA greenlights Abbott’s Freestyle Libre 3 system ahead of ADA
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FDA greenlights Abbott’s Freestyle Libre 3 system ahead of ADA

May 31, 2022
By Catherine Longworth
Abbott Laboratories Inc. announced U.S. FDA clearance for its next-generation Freestyle Libre 3 continuous glucose monitor (CGM) system for people aged 4 years and older with diabetes. Accuracy of the sensor was evaluated in a non-randomized, multicenter, single-arm study with 100 people on intensive insulin therapy (95, aged 6 years and older). Results from the pivotal trial were released May 31, showing it is the first CGM to demonstrate a mean absolute relative difference (MARD) below 8%, indicating it will be one of the most accurate sensors on the market.
BioWorld MedTech Regulatory American Diabetes Association Diabetes Continuous glucose monitor (CGM) FDA

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