FDA Approves Over-the-Counter Glucose Monitoring System for Weight Management

The FDA has approved the Signos Glucose Monitoring System for over-the-counter use, helping individuals manage weight and improve metabolic health through personalized, AI-driven insights.
The U.S. Food and Drug Administration (FDA) has officially approved the Signos Glucose Monitoring System for over-the-counter use, specifically designed to aid in weight management. This innovative system combines the Dexcom Stelo biosensor with an AI-powered platform that provides real-time insights into how food intake, physical activity, stress, sleep, and timing influence glucose levels. By integrating advanced technology with personalized health guidance, Signos aims to empower individuals to make informed decisions about their lifestyle and health.
One of the standout features of this device is its ability to translate fluctuations in glucose into simple, actionable recommendations. It uses the body's own signals, analyzed through artificial intelligence, to guide users in optimizing sleep, managing weight, and reducing the risk of chronic diseases. The system also tracks responses to meals, exercise, sleep, and stress, connecting these factors to glucose levels to foster better health habits.
Users can subscribe to Signos through plans costing $139 per month for three months or $129 per month for six months, with the company providing all necessary continuous glucose monitors during the subscription period. This development comes at a critical time, as data shows that nearly 74% of U.S. adults are classified as overweight or obese, and projections indicate that diabetes diagnoses could reach 1.3 billion globally by 2050. The rapid escalation of metabolic health issues underscores the importance of accessible, technology-driven management tools.
Sharam Fouladgar-Mercer, CEO and founder of Signos, remarked that this initiative goes beyond launching a product—it's about transforming how people see and manage their health. He emphasizes that everyone should have access to personalized insights that promote healthier, longer lives. Signos' approach focuses on giving individuals control over their health journeys through data and technology, creating a new standard in metabolic health support.
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