Freestyle Libre 3 Continuous Glucose Monitor Gets FDA Approval

Multinational medical device and healthcare company Abbott Laboratories has scored a 510(k) clearance from the FDA for the updated iteration of its continuous glucose monitor (CGM), Freestyle Libre 3. Considerably thinner and lighter than the previous version, the device, which lasts for two weeks, is roughly the size of two pennies stacked together. Abbott considers it the most accurate 14-day CGM on the market, and its assertion is backed up by results published in an abstract from the American Diabetes Association’s 82nd Scientific Sessions

A rival in the CGM field, Dexcom, which is awaiting a reportedly impending FDA approval for its own G7 system, is surely sore that Abbott is now off and running with the Freestyle Libre 3. The latter’s emphasis on affordability and size as well as accuracy will make it a market mainstay. Indeed, Abbott is banking on a fair price point by selling the device for the same price as its predecessor despite its reduced size and 33-foot Bluetooth range.

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The $1 billion in global first quarter sales of Freestyle Libre devices is fairly impressive given the fact that a mere fraction of individuals with diabetes actually use the device—as Abbott put it, “approximately four million people across more than 60 countries.”

“The news is a positive one as Libre is an important growth driver for [Abbott], and the clearance allows the company to bring its latest generation diabetes technology to market,” wrote analysts from RBC Capital Markets. “Libre 3 has seen strong traction overseas, and we expect strong uptake in the U.S. as well.” Abbott projects that sales of Libre devices will surge to $4.5 billion this year and potentially $8 billion in 2025.