Evaluation of the Accuracy of Cuffless Blood Pressure Measurement Devices: Challenges and Proposals
Open accessAbstract
Several novel cuffless wearable devices and smartphone applications claiming that they can measure blood pressure (BP) are appearing on the market. These technologies are very attractive and promising, with increasing interest among health care professionals for their potential use. Moreover, they are becoming popular among patients with hypertension and healthy people. However, at the present time, there are serious issues about BP measurement accuracy of cuffless devices and the 2021 European Society of Hypertension Guidelines on BP measurement do not recommend them for clinical use. Cuffless devices have special validation issues, which have been recently recognized. It is important to note that the 2018 Universal Standard for the validation of automated BP measurement devices developed by the American Association for the Advancement of Medical Instrumentation, the European Society of Hypertension, and the International Organization for Standardization is inappropriate for the validation of cuffless devices. Unfortunately, there is an increasing number of publications presenting data on the accuracy of novel cuffless BP measurement devices, with inadequate methodology and potentially misleading conclusions. The objective of this review is to facilitate understanding of the capabilities and limitations of emerging cuffless BP measurement devices. First, the potential and the types of these devices are described. Then, the unique challenges in evaluating the BP measurement accuracy of cuffless devices are explained. Studies from the literature and computer simulations are employed to illustrate these challenges. Finally, proposals are given on how to evaluate cuffless devices including presenting and interpreting relevant study results.
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Cuffless devices have accuracy problems not seen in automated cuff devices, including the need for individual calibration and questionable accuracy in tracking BP changes after calibration.
“However, cuffless devices have specific accuracy issues that are not present in the automated cuff BP devices, such as the need for individual user calibration and their questionable accuracy in tracking BP changes after calibration55,56.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [55]
The Types of Cuffless BP Measurement Devices section says cuff-calibrated devices require calibration for an individual, but calibration-free devices do not. The Critical Review section says the accuracy of cuff-calibrated devices in tracking BP changes within an individual often remains unclear. Thus the tracking concern is supported, while the need for individual calibration does not apply to cuffless devices generally; page numbers were not provided. (LLM, conf=0.85)
Experimental — accuracy not yet measuredCuffless devices can provide detailed information about true BP profile and behaviour over time and about all types of BP variability.
“Therefore, these devices can provide detailed information on true BP profile and behaviour over time, as well as all types of BPV (including short-term to long-term BPV6,55–57), and have great potential for use in screening, early diagnosis, close monitoring and optimal management of hypertension.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [55]
The Potential of Cuffless Blood Pressure Measurement Devices section says these devices could provide a complete evaluation of BP level and behavior across daily circumstances and long periods. But the Critical Review of Data Presentation in Recent Studies cautions that their accuracy in tracking short- or long-term BP changes within an individual often remains unclear. The source therefore supports the potential for detailed monitoring, not the unqualified claim that cuffless devices can characterize all types of BP variability. (LLM, conf=0.85)
Experimental — accuracy not yet measuredCuffless BP technologies in wearables and smartphones can take multiple or continuous measurements during routine activities over days, weeks or months without cuff-induced limb compression.
“Cuffless BP technologies embedded in wearable devices and smartphones can obtain multiple or even continuous measurements during routine activities for days, weeks or months, without the discomfort of cuff-induced limb compression.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [55]
“The Potential of Cuffless Blood Pressure Measurement Devices” (page unavailable) describes numerous measurements from wearables and smartphones across daily circumstances and long periods. It does not establish continuous measurement for months or discuss discomfort from limb compression; “Types of Cuffless BP Measurement Devices” (page unavailable) also notes that some devices require periodic arm-cuff calibration. (LLM, conf=0.83)
Experimental — accuracy not yet measuredMost cuffless BP devices require initial calibration for each user and periodic recalibration over time.
“Most of these devices require initial calibration in each user, which is usually performed by inputting a BP value measured using an upper-arm-cuff device or by inputting simple demographic data that are known to correlate with BP level (such as age and sex), with periodic recalibration required over time (every few hours, days or weeks).”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [55]
The “Types of Cuffless BP Measurement Devices” section says cuff-calibrated devices require periodic arm-cuff measurements, with intervals ranging from hours to weeks. It also identifies calibration-free devices that do not require calibration for each user, and does not establish that most devices require it. The “Simulation study” section treats demographic input as a feature of some calibration-free devices, not as periodic recalibration. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCuffless BP devices use various parameters and techniques and have different intended uses.
“These devices use several different parameters and techniques to assess BP levels, including pulse transit time, pulse wave analysis, photoplethysmography and applanation tonometry, and have different intended uses (such as wearable devices for occasional use or for short-term continuous monitoring in an intensive care unit)55,56.”
From Blood pressure and its variability: classic and novel measurement techniques (2022) · cites this paper as [55]
Standards have been developed for the validation of wearable, cuffless BP devices, although further work is required to refine validation standards to account for issues presented by PPG-based devices.
“Standards have been developed for the validation of wearable, cuffless BP devices [168], [169] although further work is required to refine validation standards to account for the issues presented by PPG-based devices [170].”
From Wearable Photoplethysmography for Cardiovascular Monitoring (2022) · cites this paper as [170]
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- Authors
- Mukkamala, R., Yavarimanesh, M., Natarajan, K., Hahn, J.-O., Kyriakoulis, K. G., Avolio, A. P., & Stergiou, G. S.
- Affiliations
- University of Pittsburgh (US)
- Michigan State University (US)
- University of Maryland, College Park (US)
- National and Kapodistrian University of Athens (GR)
- Macquarie University (AU)
- ORCID
- Venue
- Hypertension
- Published
- 2021-11
- Volume
- 78
- Issue
- 5
- Pages
- 1161-1167
- ISSN
- 0194-911X (ISSN-L)
- 1524-4563
- PMC
- PMC8516718
- OpenAlex
- W3200345925
- Cited by
- 211
- References
- 29
- Citations by year
- 2026: 37 · 2025: 43 · 2024: 38 · 2023: 50 · 2022: 42 · 2021: 1
- FWCI
- 2.76
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hypertension (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Heart, Lung, and Blood Institute (R01HL146470)
- National Institute of Biomedical Imaging and Bioengineering (U01EB018818)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- cuffless blood pressure measurement, measurement accuracy
- MeSH terms
- Wearable Electronic Devices, Blood Pressure, Blood Pressure Determination, Humans, Hypertension, Self Care, Sensitivity and Specificity, Signal Processing, Computer-Assisted, Reproducibility of Results, Pulse Wave Analysis
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