Abbott Receives FDA Approval for Two Over-the-counter CGM Systems

Abbott has received U.S. FDA clearance for two new over-the-counter continuous glucose monitoring (CGM) systems, Lingo™ and Libre Rio™, based on the FreeStyle Libre® technology for 6 million users. Lingo is designed for health-conscious consumers seeking to improve their overall wellness, while Libre Rio is tailored for adults with Type 2 diabetes who manage their condition through lifestyle changes rather than insulin use.

Lingo, a consumer biowearable, targets individuals aged 18 and older who want to enhance their health and wellness. The device tracks glucose levels and offers personalized insights and coaching to help users develop healthy habits, improve metabolism, and overall well-being. It features a biosensor worn on the upper arm for 14 days, continuously streaming glucose data to a smartphone app, which interprets the body’s responses to food, exercise, and stress. Dr. Fred St. Goar, cardiologist and medical director of El Camino Health Heart and Vascular Institute, highlights the holistic benefits of continuous glucose monitors, noting their potential to reduce long-term risks of cardiovascular disease, diabetes, Alzheimer’s, and certain cancers by promoting overall lower glucose levels.

Libre Rio is Abbott’s first over-the-counter CGM system for individuals with Type 2 diabetes in the U.S. Aimed at those 18 and older who manage their diabetes through lifestyle modifications, Libre Rio offers a measurement range of 40-400 mg/dL to detect extremely low or high glucose events. This addition to Abbott’s Libre portfolio, which includes the prescription-based FreeStyle Libre 2 and FreeStyle Libre 3 systems, could facilitate broader adoption of CGM technology among Americans with diabetes. By providing actionable glucose data, Libre Rio empowers users to engage in informed discussions with their healthcare providers, potentially enhancing diabetes management and overall health outcomes.

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