FreeStyle Libre 3 Receives FDA Clearance for Diabetes in Patients 4 Years and Older


The FreeStyle Libre 3 system, which is billed by Abbott as the world's smallest, thinnest, and most accurate 14-day glucose sensor, received FDA clearance on May 31 and is expected to be available in participating pharmacies later this year.

FDA logo in white over a blue backdrop.

The FreeStyle Libre 3 system from Abbott has received clearance from the US Food and Drug Administration for use by people aged 4 years and older living with diabetes.

Announced by Abbott in a statement on May 31, the FreeStyle Libre 3 is expected to be available later this year at participating pharmacies and will be available at the same price as previous versions of the system.

"The FreeStyle Libre 3 system is a direct result of listening to our customers – and giving them the innovation and sensing technology they've been looking for," said Jared Watkin, senior vice president of Abbott's diabetes care business. "It's a game-changer for the millions of people living with diabetes. They'll be able to manage their health minute-by-minute with the world's smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system."

Billed as the world’s smallest, thinnest, and most accurate 14-day glucose sensor, the FreeStyle Libre 3 system is the size of 2 stacked US pennies and has a Bluetooth integration range of up to 33 feet. With the ability to pair with the FreeStyle Libre 3 iOS and Android mobile apps, the system allows users to view glucose levels in real-time, track their glucose history and trends, and set up optional alarms.

According to Abbott, the FreeStyle Libre 3 system is the first continuous glucose monitoring system to demonstrate a sub 8% MARD, with a 7.9% overall MARD. Additionally, the app also allows integration with the FreeStyle digital ecosystem, which includes products such as LibreView and LibreLinkUp, and allows for caregivers and providers to monitor glucose trends and history as needed.

In their statement, Abbott pointed out the FreeStyle Libre 3 system was the recipient of multiple awards and honors in the past year, including being recognized as the Consumer Technology Association's 2022 Consumer Electronics Show Best Health and Wellness Innovation, the Edison 2022 Gold Award for Science and Medical, Technology and Tools, and the Business Intelligence Group’s 2022 Healthcare Innovation Award.

"I have seen real-world evidence that diabetes technologies like CGMs have helped my patients safely achieve improved glycemic control," said Eugene E. Wright, Jr., MD, consulting associate at Duke University's department of medicine. "I applaud Abbott for making their CGM system the most affordable and addressing disparities in care so patients living with diabetes can avoid complications and optimize their quality of life."

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