Abbott receives FDA approval for Libre Rio and Lingo


Abbott Chairman and CEO Robert B. Ford delivers a keynote speech at CES 2022 at The Venetian Las Vegas on January 6, 2022 in Las Vegas, Nevada.

Ethan Miller | fake images

Abbott Laboratories announced Monday that it has received approval from the U.S. Food and Drug Administration for two new continuous glucose monitoring systems, including one for people who do not have diabetes. Both will be available over the counter and over the counter.

A continuous glucose monitor, or CGM, is a small sensor that passes through the skin and tracks a person's glucose levels in real time. Transmit this data wirelessly to a smartphone. CGMs are primarily used by patients with diabetes, as the technology can help alert users, their families, and their doctors to emergencies.

The market opportunity could be significant for Abbott, whose existing CGMs are already used by about 6 million patients in 60 countries, Abbot said. About 38.4 million people live with diabetes in the United States alone, Abbott said, and offering consumer-oriented CGM brings the technology to a whole new population.

One of Abbott's new systems, Libre Rio, is for patients with type 2 diabetes who don't take insulin. Its second system, Lingo, is aimed at consumers trying to improve their health and well-being, according to the company.

Abbott said Lingo users will wear a biosensor on their upper arm for 14 days straight and will be able to track their glucose data within a fitness app on their phone. Participants get access to personalized training based on their data that can help them “retrain their metabolism and improve their overall well-being,” the company said.

Several companies like Signos use CGM to help people lose weight and improve their metabolic health. Users often need a valid CGM prescription to participate in these programs, so Abbott's new over-the-counter offering could be more accessible to some consumers.

Libre Rio is Abbott's first over-the-counter offering for people with diabetes in the US, although other CGMs within its portfolio have been available over the counter in other countries over the past decade. Libre Rio is designed for type 2 patients who normally manage their diabetes with lifestyle modifications, the company said.

Abbott competitor dexcomwhich also sells CGM systems, received FDA approval for its first over-the-counter CGM in March.

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