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Home » Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children

Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children

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AbbottAbbott (NYSE:ABT) announced today that it received FDA clearance for its FreeStyle Libre 2 system for adults and children ages four and older with diabetes.

The Abbott Park, Ill.-based company touts its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system as the only such system with optional real-time alarms that measure glucose levels every minute over a 14-day wear time, making it long-lasting and eliminating the need for fingersticks.

FreeStyle Libre 2 uses Bluetooth to automatically alert users when glucose is high or low, removing the need to scan the sensor. Users can also turn off the customizable alarms, should they choose to. The system digitally connects and communicates with other compatible devices to allow for diabetes management to be specifically tailored to a person’s needs.

The sensor for the FreeSytle Libre 2 is worn on the back of the upper arm for 14 days and includes one-second scan capabilities with a handheld reader so users can see glucose readings, trends and eight-hour history. Abbott is also working to bring a compatible mobile app to the U.S. market, according to a news release.

Participating pharmacies and durable medical equipment suppliers in the U.S. will offer the FreeStyle Libre 2 system in the coming weeks at the same price as the currently available FreeStyle Libre 14-day system that has been on the market for nearly two years.

“We’re thrilled to bring our next generation technology on our world-leading sensing platform to both children and adults with diabetes in the U.S.,” Abbott senior VP of diabetes care Jared Watkin said in a news release. “With unsurpassed 14-day accuracy and enhanced features including optional alarms at a fraction of the cost of other CGMs, Abbott’s FreeStyle Libre 2 system will change the future of diabetes care in the U.S. the same way it has around the globe.”

Evercore ISI analyst Vijay Kumar told Reuters that the accuracy of data from Abbott’s FreeStyle Libre 2 looks better than that of its rival glucose monitor made by Dexcom (NSDQ:DXCM), and the FreeStyle Libre is priced significantly lower than Dexcom’s product, according to Kumar.

Although Abbott shares stood still in premarket trading and Dexcom shares dipped -1.4%, shares of ABT are now down -1.8% at $87.40 in mid-morning trading, while shares of DXCM are up 1.9% at $377.23.

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