The US Food and Drug Administration (FDA) has approved Abbott’s Lingo and Libre Rio over-the-counter continuous glucose monitoring (CGM) systems.
These systems are designed for health improvement and type 2 diabetes management and are based on Abbott’s FreeStyle Libre sensing technology.
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The Lingo system is aimed at consumers aged 18 and older who seek to enhance their health and wellness.
It tracks glucose levels, offering personalised insights and coaching to promote healthy habits and metabolic improvement.
The system includes a biosensor worn on the arm for a period of 14 days, providing continuous glucose data to a smartphone application. This provides insights on the user’s reaction to exercise, food, and life’s daily stressors.
Intended for non-insulin-using individuals aged 18 and older, the Libre Rio system is said to be the first over-the-counter CGM system in the US with a glucose measurement range of 40mg/dL-400mg/dL. It can detect extremely low or high glucose events.
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By GlobalDataAbbott’s FreeStyle Libre technology is already used by approximately six million people worldwide.
Abbott medical devices business executive vice-president and group president Lisa Earnhardt said: “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.
“People living with diabetes need certain features like tracking medications or sharing data with a healthcare provider. People without diabetes need different features to manage their metabolic health, including personalised coaching to promote actionable lifestyle changes.”
The new Lingo and Libre Rio systems are designed to meet the specific needs of different consumer segments, expanding the accessibility of CGM technology to a broader audience.
Last week, Abbott secured the CE Mark in Europe for its AVEIR dual chamber leadless pacemaker system.
