Toward patient-centered blood pressure monitoring: validation of a novel low-pressure and rapid oscillometric method according to the ISO 81060-2:2018/Amd1:2020/Amd2:2024 standard

Out-of-office blood pressure (BP) measurement is central to contemporary hypertension management. However, conventional oscillometric BP monitors often require substantial cuff inflation, potentially causing discomfort, sleep disturbance, and reduced adherence to repeated BP measurement. We developed a novel low-pressure and rapid oscillometric method designed to reduce the cuff pressure and measurement duration while maintaining accuracy. Here, we evaluated the novel automated upper-arm BP monitor incorporating this method (i.e., the Omron HEM-7290T) according to the ISO 81060-2:2018/Amd1:2020/Amd2:2024 standard. The device was assessed in 85 adults using the ISO same-arm sequential measurement protocol. Reference BP values were obtained by simultaneous auscultation. The device’s performance was evaluated according to Criteria 1 and 2 of the ISO standard. For Criterion 1, the mean device–observer differences were 0.5 ± 7.09 mmHg for systolic BP (SBP) and 0.6 ± 5.50 mmHg for diastolic BP (DBP). For Criterion 2, the standard deviations of the subject-level mean differences were 5.79 mmHg for SBP and 5.05 mmHg for DBP. All results fulfilled the ISO 81060-2:2018/Amd1:2020/Amd2:2024 validation requirements across the required BP and arm circumference distributions. The Omron HEM-7290T successfully fulfilled ISO validation requirements in adults with 20- to 45-cm arm circumferences. These findings demonstrate that a low-pressure and rapid oscillometric method can achieve international-standard accuracy while potentially reducing the measurement burden. This study provides the clinical validation of a patient-centered BP monitoring technology designed to improve comfort without compromising performance, with potential applications in home BP monitoring, nocturnal BP assessment, and digital hypertension management.