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Home » Abbott wins FDA clearance for duo of over-the-counter CGMs

Abbott wins FDA clearance for duo of over-the-counter CGMs

June 10, 2024 By Sean Whooley

This is an Abbott marketing image of its Lingo over-the-counter continuous glucose monitoring system.
The Lingo over-the-counter CGM. [Image courtesy of Abbott]
Abbott (NYSE: ABT) today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.

The company built both systems on its FreeStyle Libre CGM technology, but both aim to meet different needs. Lingo offers consumers a solution to better understand and improve their health and wellness. Libre Rio provides monitoring for adults with type 2 diabetes who aren’t on insulin and manage diabetes through lifestyle modifications.

Abbott acknowledged this month that Lingo’s clearance came on May 29, but the Libre Rio sensor marks another entry into the over-the-counter CGM market. Like the companies’ prescription CGMs, Libre Rio will rival Dexcom’s Stelo for people with type 2 diabetes who do not use insulin.

“There is no one-size-fits-all approach for glucose monitoring, which is why we’ve designed different products for different people – all based on the same world-leading biowearable technology,” said Lisa Earnhardt, EVP and group president of Abbott’s medical devices business.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: 510(k), Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Health Technology, Patient Monitoring, Regulatory/Compliance Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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