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FDA Draft Guidance New Clinical Performance Guidance for Cuffless Blood Pressure Devices

Day: January 23, 2026

FDA Draft Guidance New Clinical Performance Guidance for Cuffless Blood Pressure Devices

FDA draft guidance for cuffless blood pressure device performance standards

US, 23, Jan 2026 – The U.S. Food and Drug Administration (FDA) has officially released a new draft guidance titled “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation.“ This document provides the industry with long-awaited recommendations on how to validate the accuracy and safety of cuffless technology ranging from smartwatches to […]

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