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Regulation and Approval of Continuous Non-invasive Blood-Pressure Monitoring Devices

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XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019 (MEDICON 2019)

Part of the book series: IFMBE Proceedings ((IFMBE,volume 76))

Abstract

New-generation devices that enable continuous non-invasive blood-pressure (cNIBP) monitoring as an alternative to invasive arterial blood-pressure monitoring are being developed. These include a volume-clamp method using transmural pressure control, a tonometer based on the principles of tonometry, and photoplethysmographic sensing calculated using either pulse transit time (PTT) or the second derivative signal. However, meta-analyses of cNIBPs indicate that they are not as accurate as intermittent cuff-based sphygmomanometer measurements. While most of the cNIBP devices have been approved by medical device authorities, regulatory bodies are only starting to discuss standards for them. This paper reviews the benefits and limitations of cNIBP devices and current trends in their regulation and approval.

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Acknowledgments

This work was supported in part by grants-in-aid from the Strategic Information and Communications R&D Promotion Program in 2014–2016, the Japanese Ministry of Internal Affairs, and Communication and Scientific Research (C) (Kakenhi) (#17K01440), the Japan Medical Research and Development Organization’s Integrated Research and Development Project for Persons with Disabilities (JP18dk0310077), and a Ministry of Economy, Trade and Industry project promoting a new ISO/IEC proposal.

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Authors and Affiliations

  1. Waseda University, Tokyo, Japan

    Toshiyo Tamura

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  1. Toshiyo Tamura
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Correspondence to Toshiyo Tamura .

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Editors and Affiliations

  1. University of Coimbra, Coimbra, Portugal

    Jorge Henriques

  2. Universidade do Minho, Braga, Portugal

    Nuno Neves

  3. University of Coimbra, Coimbra, Portugal

    Paulo de Carvalho

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Tamura, T. (2020). Regulation and Approval of Continuous Non-invasive Blood-Pressure Monitoring Devices. In: Henriques, J., Neves, N., de Carvalho, P. (eds) XV Mediterranean Conference on Medical and Biological Engineering and Computing – MEDICON 2019. MEDICON 2019. IFMBE Proceedings, vol 76. Springer, Cham. https://doi.org/10.1007/978-3-030-31635-8_124

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  • DOI: https://doi.org/10.1007/978-3-030-31635-8_124

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-31634-1

  • Online ISBN: 978-3-030-31635-8

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