FDA approves FreeStyle Libre for use in the USA

Last Friday (29 Sept 2017) the U.S. Food and Drug Administration (FDA) has approved the FreeStyle Libre Flash Glucose Monitoring System as a replacement1 for blood glucose monitoring (BGM) for adults with diabetes in the U.S. This revolutionary new glucose sensing technology eliminates the need for routine finger sticks1 and is the only personal continuous glucose monitor (CGM) that does not require finger stick calibration. Designed to be approachable, accessible and affordable for the 30 million people with diabetes in America6, the FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days, making it the longest lasting personal glucose sensor available in America.

The BGM replacement indication means that people with diabetes and their physicians can now make treatment decisions based on information from the FreeStyle Libre system, without the need for painful routine finger sticks1—and at a fraction of the cost of other CGM systems currently available7.

*Fingerstick blood tests are required for treatment decisions when you see the Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
Abbott FDA news

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