Key result
Cuffless BP devices advance rapidly but clinical utility remains highly dependent on calibration and setting.
Why the study?
Evaluating wearable and portable cuffless BP devices is complicated by technological heterogeneity, calibration, sensitivity to dynamic conditions, and recent device-specific standards.
Do wearable and portable cuffless devices accurately measure or estimate blood pressure compared to conventional methods across different populations and settings?
Do wearable and portable cuffless devices accurately measure or estimate blood pressure compared to conventional methods across different populations and settings?
While wearable and cuffless blood pressure devices show technological promise, their clinical adoption requires device-specific validation under real-world dynamic conditions rather than extrapolating performance from static, controlled settings.
Cuffless BP wearables face validation hurdles; leaves open standardized clinical adoption pending further trials.
Background: Out-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. Objective: To 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. Methods: A 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. Results: Sixty-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. Conclusions: The 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.
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Bustamante-Rodríguez et al. (2026) conducted a review in Hypertension (n=63). Wearable, cuffless, and portable blood pressure monitoring devices vs. Conventional blood pressure measurement methods (auscultation, ABPM, invasive) was evaluated on Device performance, calibration requirements, and clinical validation. Wearable and cuffless blood pressure devices show rapid technological progress, but their clinical utility remains highly dependent on calibration, intended use, and setting, preventing extrapolation across different technologies.
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