Wearable cuffless blood pressure monitors can provide important diagnostic and prognostic insights for cardiovascular care. However, their safe and effective clinical adoption depends on rigorous, multi-framework validation strategies capable of ensuring accuracy, building clinical trust and supporting equitable global implementation.
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Draft guidance issued by the US Food and Drug Administration (FDA): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cuffless-non-invasive-blood-pressure-measuring-devices-clinical-performance-testing-and-evaluation
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Sadasivam, K., Sinha, S., KNR, A. et al. Multi-framework validation of wearable cuffless blood pressure monitors. Nat Rev Bioeng (2026). https://doi.org/10.1038/s44222-026-00422-w
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DOI: https://doi.org/10.1038/s44222-026-00422-w
