CUFFLESS BLOOD PRESSURE DEVICES / WEARABLE DEVICE STUDIES
PRL supports the evaluation of cuffless and wearable blood pressure devices by aligning with the evolving regulatory landscape. We are contributing members to the development of ISO 81060-7, the forthcoming international standard for cuffless BP devices, and are already aligned with the FDA Draft Guidance (Jan 2026) on cuffless devices. Additionally, we are actively contributing to the revision of ISO 81060-3, the standard governing continuous automated blood pressure measurement systems.
Cuffless BP studies at PRL are tailored to each device’s technology and may incorporate a variety of study designs, including multi-visit, multi-location, and induced blood pressure change protocols. We are experienced in designing studies aligned with IEEE 1708a:2019, including the ability to meet its challenging demographic distribution requirements, such as enrollment of participants in higher blood pressure ranges. Depending on study objectives, reference measurements may include dual auscultation or arterial line blood pressure, enabling generation of robust datasets for algorithm development, performance characterization, and regulatory submissions.
DUAL AUSCULTATION AS A REFERENCE
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Staff with over 15 years of experience conducting studies using dual auscultation as a reference method
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Observers trained in identifying Korotkoff sounds per the 1993 BHS protocol, including qualification using 50 reference measurements and periodic reassessments
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Demonstrated exceptional inter-observer agreement, with systolic and diastolic differences within 4 mmHg in 99.7% of paired measurements
ARTERIAL LINE AS A REFERENCE
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3,000+ arterial lines placed since 2022 by Principal Investigator Dr. Arthur Cabrera, board certified anesthesiologist
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Trained registered nurses experienced in arterial line management, waveform quality assessment, and participant monitoring
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Signal adequacy assessed in accordance with Gardner recommendations
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