FDA Approves First Wearable Device to Simultaneously Monitor Ketones and Glucose

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The U.S. Food and Drug Administration approved the KetoGlucose wearable device in April 2024, marking the first time a single wearable has received clearance to continuously monitor both ketone and glucose levels. The device measures biomarkers every five minutes via biochemical electrodes and transmits data wirelessly to a smartphone, eliminating the need for needles or lab visits. It is designed to benefit a wide range of users, including endurance athletes, people with type 1 or type 2 diabetes, and those following ketogenic diets. The wearable offers accuracy within roughly 5% for ketones and 3% for glucose — close to lab standards for real-time decision-making, though not a replacement for clinical diagnostic tests. The approval is seen as a significant development given that over 34 million Americans live with diabetes and low-carb diets continue to grow in popularity.

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