Abbott’s Libre 3 gets FDA clearance

Having already received a CE mark in September 2020 for FreeStyle Libre 3 (FSL3), the latest version of its continuous glucose monitor, Abbott has now received 510(k) clearance from the Food and Drug Administration.

The 14-day device is smaller and thinner than its predecessor and sends readings to a connected smartphone every minute. Abbott claims that Libre 3 is the most accurate 14-day CGM, based on results published in the American Diabetes Association’s 82nd Scientific Sessions.

The clearance gives Abbott an opportunity to maintain its momentum in the US. Abbott is selling Libre 3 at the same price as its predecessor and this focus on affordability comes as it tries to convert more users to Libre. While Abbott says its Libre CGMs are used by “approximately four million people across more than 60 countries”, the device is currently used by only a fraction of people living with diabetes.

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