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Wearable; cuffless; and portable devices for blood pressure monitoring (2015–2025): a scoping review of technologies; calibration; clinical validation; and regulatory frameworks
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DOI:10.3389/fdgth.2026.1870156.png)
Abstract
En 中文
BackgroundOut-of-office blood pressure (BP) monitoring is essential for diagnosing and controlling hypertension. Between 2015 and 2025; wearable devices and portable cuffless platforms emerged that estimate BP without a conventional brachial cuff; their evaluation is complicated by technological heterogeneity; calibration; sensitivity to dynamic conditions; and recent device-specific standards.ObjectiveTo map the evidence published between 2015 and 2025 on wearable and portable cuffless devices for BP measurement or estimation; describing form factors; technologies; calibration/recalibration; validation; populations; settings; and standards or regulatory frameworks.MethodsA scoping review was conducted in accordance with PRISMA-ScR and the Joanna Briggs Institute; using the PCC framework. Sources were searched in PubMed/MEDLINE; Scopus; Web of Science; and Embase; supplemented by device-directed searches and citation chasing. Extraction captured population; device; technology; setting; calibration; standard/protocol; comparator; metrics; limitations; conflicts; and funding.ResultsSixty-three sources were included: 7 standards/consensus/regulatory documents; 1 case study; 6 reviews; and 49 primary studies. Primary evidence covered watches with miniaturized cuffs; wearable or portable cuffless devices; and rings/finger devices. Oscillometric wrist watches were methodologically closer to conventional automated monitors; although limited by positioning requirements; reading errors; and scarce ambulatory evidence. Cuffless devices relied on PPG/PWA; PTT/PAT; tonometry; or multimodal approaches; with calibration/recalibration and proprietary algorithms. Critical gaps persisted in post-calibration stability; dynamic conditions; sleep; treatment; arrhythmias; and special populations.ConclusionsThe 2015–2025 ecosystem shows rapid progress and a transition toward cuffless-specific validation. However; clinical utility depends on intended use; population; calibration/recalibration; and setting. Performance should not be extrapolated across technologies; populations; or contexts.
Keywords:
hypertension
scoping review
wearable electronic devices
blood pressure
photoplethysmography
validation study
ambulatory blood pressure monitoring
cuffless devices
Journal
F
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3.8
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2.0K
Citations:
3.1K
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