FDA approves two new Abbott over-the-counter continuous glucose monitors

Abbott has FDA clearance for two new over-the-counter continuous glucose monitoring systems

FDA approves two new Abbott over-the-counter continuous glucose monitors

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

Ethan Miller | Getty Images

Abbott Laboratories announced Monday it received approval from the U.S. Food and Drug Administration for two new continuous glucose monitoring systems, including one for people who don't have diabetes. Both will be available over the counter without a prescription.

A continuous glucose monitor, or a CGM, is a small sensor that pokes through the skin and tracks a person's glucose levels in real time. It wirelessly transmits this data to a smartphone. CGMs are primarily used by patients with diabetes since the tech 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 around 6 million patients across 60 countries, Abbot said. Around 38.4 million people are living with diabetes in the U.S. alone, Abbott said, and offering a consumer-facing CGM brings the technology to an entirely new population.

One of Abbott's new systems, Libre Rio, is for patients with Type 2 diabetes who do not take insulin. Its second system, Lingo, is for consumers trying to improve their health and wellness, according to the company.

Abbott said Lingo users will wear a biosensor on their upper arm for 14 days at a time, and they can track their glucose data within a coaching app on their phone. Participants get access to customized coaching based on their data that can help them "retrain their metabolism and improve their overall wellbeing," the company said.

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

Libre Rio is Abbott's first over-the-counter offering for people with diabetes in the U.S., though other CGMs within its portfolio have been available without a prescription in other countries over the last decade. Libre Rio is designed for Type 2 patients who usually manage their diabetes with lifestyle modifications, the company said.

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

Don’t miss these exclusives from CNBC PRO