The US FDA Clears Abbott’s Two New Over-The-Counter Continuous Glucose Monitoring Systems


The US FDA has granted clearance to 2 OTC CGM systems, Lingo & Libre Rio, based on FreeStyle Libre sensing technology
The Lingo system, a biowearable to improve overall health & wellness in ≥18yrs. users, track glucose using a biosensor worn for 14 days on the upper arm & displays the data on a smartphone generating insights on diet, exercise & stress to develop healthy habits & improve overall well-being
The Libre Rio system, with a range of 40-400mg/dL intended for T2D in ≥18yrs. non-insulin users measure glucose levels using a biosensor worn on the back of the arm for up to 15 days. Clinical results & RWE have shown its ability to improve glucose control, lowering HbA1c & reducing diabetes-related hospital admissions

Ref: Abbott | Image: Abbott

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