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As the paradigm of healthcare delivery continues to shift from traditional clinical settings to patient-centric home environments, sensor-based digital health technologies (sDHTs) have rapidly emerged as indispensable tools for real-time, non-invasive health monitoring. Reflecting this evolution, the U.S. Food and Drug Administration (FDA) has published a robust list of over 250 authorised sDHT medical devices cleared between 2014 and 2025. Spanning smart rings, wearable biosensors, adhesive patches, and continuous glucose monitors, these technologies have undergone rigorous FDA evaluation to ensure safety, effectiveness, and technological integrity.
This curated list serves a dual purpose: it offers healthcare providers and patients a transparent reference for clinically validated sDHT solutions, and it acts as a regulatory compass for innovators developing next-generation remote monitoring systems. Amid growing demand for decentralised, data-driven care, the FDA’s ongoing efforts to promote clarity and confidence in the digital health space underscore a broader commitment—championing innovation while safeguarding public health in an increasingly connected world.
