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

Tamura, Toshiyo

doi:10.1007/978-3-030-31635-8_124

Cited by 4 publications

(6 citation statements)

References 25 publications

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“…2a-c). Some devices based on PTT or PWA and requiring periodic cuff BP calibrations have some regulatory approval and are already available on the market [31,[46][47][48], yet they are not currently recommended for clinical use [2]. These devices estimate BP changes from the initial cuff calibration BP.…”

Section: Technologies Requiring User Cuff Calibrationmentioning

confidence: 99%

Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

Stergiou

Mukkamala

Avolio

et al. 2022

Journal of Hypertension

112

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Background:Many cuffless blood pressure (BP) measuring devices are currently on the market claiming that they provide accurate BP measurements. These technologies have considerable potential to improve the awareness, treatment, and management of hypertension. However, recent guidelines by the European Society of Hypertension do not recommend cuffless devices for the diagnosis and management of hypertension.Objective:This statement by the European Society of Hypertension Working Group on BP Monitoring and Cardiovascular Variability presents the types of cuffless BP technologies, issues in their validation, and recommendations for clinical practice.Statements:Cuffless BP monitors constitute a wide and heterogeneous group of novel technologies and devices with different intended uses. Cuffless BP devices have specific accuracy issues, which render the established validation protocols for cuff BP devices inadequate for their validation. In 2014, the Institute of Electrical and Electronics Engineers published a standard for the validation of cuffless BP devices, and the International Organization for Standardization is currently developing another standard. The validation of cuffless devices should address issues related to the need of individual cuff calibration, the stability of measurements post calibration, the ability to track BP changes, and the implementation of machine learning technology. Clinical field investigations may also be considered and issues regarding the clinical implementation of cuffless BP readings should be investigated.Conclusion:Cuffless BP devices have considerable potential for changing the diagnosis and management of hypertension. However, fundamental questions regarding their accuracy, performance, and implementation need to be carefully addressed before they can be recommended for clinical use.

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Section: Technologies Requiring User Cuff Calibrationmentioning

confidence: 99%

Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

Stergiou

Mukkamala

Avolio

et al. 2022

Journal of Hypertension

112

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show abstract

“…Form factor: Conversion of smartphones into calibration-free BP monitors would improve hypertension awareness, whereas development of wearables, even with a cuff-calibrated method, is needed for hypotension surveillance in addition to hypertension diagnosis. Evaluation: Compelling evaluation of cuffless methods is a must (5,96,127). For example, machine learning models must show added value over baseline models in which the physiological measurement is excluded as input.…”

Section: Discussionmentioning

confidence: 99%

“…The opportunity for such monitoring is as high as ever due to recent technological advances, including the proliferation of smartphones with sensors therein and unobtrusive wearable sensing. For these two reasons, studies on cuffless BP measurement have been increasingly appearing in the literature, and devices are now emerging in the marketplace (5)(6)(7)(8)(9). Despite considerable advances, the realization of cuffless BP monitoring has proved difficult, and to date, no device or measurement principle has been widely accepted.…”

Section: Introductionmentioning

confidence: 99%

Cuffless Blood Pressure Measurement

Mukkamala

Stergiou

Avolio

2022

Annu. Rev. Biomed. Eng.

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Cuffless blood pressure (BP) measurement has become a popular field due to clinical need and technological opportunity. However, no method has been broadly accepted hitherto. The objective of this review is to accelerate progress in the development and application of cuffless BP measurement methods. We begin by describing the principles of conventional BP measurement, outstanding hypertension/hypotension problems that could be addressed with cuffless methods, and recent technological advances, including smartphone proliferation and wearable sensing, that are driving the field. We then present all major cuffless methods under investigation, including their current evidence. Our presentation includes calibrated methods (i.e., pulse transit time, pulse wave analysis, and facial video processing) and uncalibrated methods (i.e., cuffless oscillometry, ultrasound, and volume control). The calibrated methods can offer convenience advantages, whereas the uncalibrated methods do not require periodic cuff device usage or demographic inputs. We conclude by summarizing the field and highlighting potentially useful future research directions. Expected final online publication date for the Annual Review of Biomedical Engineering, Volume 24 is June 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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“…Thus, cuffless BP devices are now available on the market and are garnering great interest from doctors, patients, members of the public, and researchers. [5][6][7][8][9][10] It is important to note that these devices are heterogenous in several respects. First, they use different principles and methods for estimating BP.…”

Section: The Emerging Market Of Cuffless Bp Devicesmentioning

confidence: 99%

“…Four regression models were developed to predict systolic BP (SBP) and diastolic BP (DBP) from features of the (1) tonometry and ECG waveforms (eg, similar to the Food and Drug Administration (FDA)-cleared Healthstats and LiveMetric devices 9,10 but also including additional ECG information); (2) PPG and ECG waveforms (eg, similar to the FDA-cleared Sotera device 5 ); (3) PPG waveform (eg, similar to the FDA-cleared Biobeat, CE-marked Aktiia, and South Korea regulator-approved Samsung devices 6–8 ); and (4) ECG waveform alone (Figure 1D; Table 2). The models also considered the time of day, which may help in tracking typical diurnal BP variations (eg, BP is lower at night), and arm posture via the accelerometer (see, for example, the study by Shaltis et al 14 ) as non-waveform features for predicting BP.…”

Section: The Microsoft Research Aurora Project On Assessing the Accur...mentioning

confidence: 99%

The Microsoft Research Aurora Project: Important Findings on Cuffless Blood Pressure Measurement

et al. 2023

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Conventional blood pressure (BP) measurement devices based on an inflatable cuff only provide a narrow view of the continuous BP profile. Cuffless BP measuring technologies could permit numerous BP readings throughout daily life and thereby considerably improve the assessment and management of hypertension. Several wearable cuffless BP devices based on pulse wave analysis (applied to a photoplethysmography or tonometry waveform) with or without use of pulse arrival time are now available on the market. The key question is: Can these devices provide accurate measurement of BP? Microsoft Research recently published a complex article describing perhaps the most important and highest resource project to date (Aurora Project) on assessing the accuracy of several pulse wave analysis and pulse wave analysis-pulse arrival time devices. The overall results from 1125 participants were clear-cut negative. The present article motivates and describes emerging cuffless BP devices and then summarizes the Aurora Project. The study methodology and findings are next discussed in the context of regulatory-cleared devices, physiology, and related studies, and the study strengths and limitations are pinpointed thereafter. Finally, the implications of the Aurora Project are briefly stated and recommendations for future work are offered to finally realize the considerable potential of cuffless BP measurement in health care.

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

Cited by 4 publications

References 25 publications

Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

Cuffless blood pressure measuring devices: review and statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability

Cuffless Blood Pressure Measurement

The Microsoft Research Aurora Project: Important Findings on Cuffless Blood Pressure Measurement

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