A pocket-size cuffless electronic device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense Inc., Zhubei, Taiwan). The device estimates BP within 10 s using three embedded electrodes and one force sensor that is applied over the radial pulse to evaluate the pulse wave. Before use, basic anthropometric characteristics are recorded on the device, and individualized initial calibration is required based on a standard BP measurement performed using an upper-arm BP monitor. The device performance in providing valid BP readings was evaluated in 313 normotensive and hypertensive adults in three study phases during which the device sensor was upgraded. A formal validation study of a prototype device against mercury sphygmomanometer was performed according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 2013 protocol. The test device succeeded in obtaining a valid BP measurement (three successful readings within up to five attempts) in 55–72% of the participants, which reached 87% with device sensor upgrade. For the validation study, 125 adults were recruited and 85 met the protocol requirements for inclusion. The mean device-observers BP difference was 3.2±6.7 (s.d.) mm Hg for systolic and 2.6±4.6 mm Hg for diastolic BP (criterion 1). The estimated s.d. (inter-subject variability) were 5.83 and 4.17 mm Hg respectively (criterion 2). These data suggest that this prototype cuffless BP monitor provides valid self-measurements in the vast majority of adults, and satisfies the BP measurement accuracy criteria of the ANSI/AAMI/ISO 2013 validation protocol.
This is a preview of subscription content, access via your institution
Subscribe to this journal
Receive 12 digital issues and online access to articles
$119.00 per year
only $9.92 per issue
Rent or buy this article
Get just this article for as long as you need it
Prices may be subject to local taxes which are calculated during checkout
Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D et al. Call to action on use and reimbursement for home blood pressure monitoring: executive summary: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension 2008; 52: 1–29.
Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y et al. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary report of the Second International Consensus Conference on Home Blood Pressure Monitoring. J Hypertens 2008; 26: 1505–1526.
Stergiou GS, Christodoulakis GR, Nasothimiou EG, Giovas PP, Kalogeropoulos PG . Can validated wrist devices with position sensors replace arm devices for self-home blood pressure monitoring? A randomized crossover trial using ambulatory monitoring as reference. Am J Hypertens 2008; 21: 753–758.
Parati G, Asmar R, Stergiou GS . Self blood pressure monitoring at home by wrist devices: a reliable approach? J Hypertens 2002; 20: 573–578.
Medaval. The Standard for Medical Device Evaluation. Blood pressure monitors for home use. Available at http://www.medaval.org/ (accessed 6 September 2016).
American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization. Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type. ANSI/AAMI/ISO 81060-2:2013. Available at http://webstore.ansi.org (accessed 6 September 2016).
O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, Altman DG et al. An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens 1993; 11: 677–679.
Corresponding author’s institution has received financial support for the present work from Maisense Inc., Zhubei, Taiwan.
GSS has received consultation fees by Maisense. B Chiu and B Chen are Maisense engineers who contributed to the design of feasibility studies presented in this paper, and used these data during the study for further technological development of the test device. They were not involved in any way in the design, execution and analysis of the validation study. The remaining authors declare no conflict of interest.
Rights and permissions
About this article
Cite this article
Boubouchairopoulou, N., Kollias, A., Chiu, B. et al. A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation. J Hum Hypertens 31, 479–482 (2017). https://doi.org/10.1038/jhh.2016.101
This article is cited by
Draft Proposal of an Optical Cuffless Blood Pressure Device
Health and Technology (2020)