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Latest Regulatory Intelligence
FDA authorizes the first wearable that continuously monitors both ketones and blood sugar
The FDA granted marketing authorization to Abbott Diabetes Care for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, for people aged 2 years and older living with diabetes. It is the first wearable in the United States to monitor ketone levels continuously, and the first anywhere to read ketones and glucose from a single device. The device measures both every minute in the fluid just beneath the skin, streams readings to a compatible smartphone with trend direction, and alerts users when ketones reach a concerning threshold, supporting earlier recognition of diabetic ketoacidosis.
Pathway: De Novo premarket review with special controls, following a Breakthrough Device designation. Six clinical studies enrolled more than 600 participants aged 2 years and older across the 10-day wear period. Ketone results should be interpreted alongside glucose readings and symptoms, never in isolation.
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