Evidence map›Paper›PMID 41777561›Full record

ArticleVascular health and risk management2026

Accuracy of the Withings BPM Pro 2 (WPM07) Device for Self-Blood Pressure Measurements in the General Populations According to the International Organization for Standardization Universal Standard (ISO 81060-2:2018/AMD 2:2024) Protocol.

Parounak Zelveian, Zoya Hakobyan, Jirar Topouchian, Avag Avagyan, Heghine Gharibyan, Roland Asmar

Abstract readValidation StudyComparative Study
In one paragraph

Article in Vascular health and risk management, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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2 · The registry

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4 · The record

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5 · Who and what money

Authors and funding

6 authors.

Parounak ZelveianCenter of Preventive Cardiology, Hospital N2 CJSC, Yerevan, Armenia.ORCID 0000-0002-6513-6772
Zoya HakobyanCenter of Preventive Cardiology, Hospital N2 CJSC, Yerevan, Armenia.ORCID 0000-0002-9587-2252
Jirar TopouchianDiagnosis and Therapeutic Center, Hôtel Dieu Hospital, Paris, France.
Avag AvagyanArtemis Medical Center, Yerevan, Armenia.
Heghine GharibyanCenter of Preventive Cardiology, Hospital N2 CJSC, Yerevan, Armenia.
Roland AsmarFoundation-Medical Research Institutes (F-MRI), Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The accuracy of blood pressure (BP) measurements performed by electronic devices is crucial in clinical practice. International professional societies emphasize the need for rigorous, standardized validation of electronic BP measuring devices to ensure their accuracy and reliability. Objective: This study evaluated the accuracy of the Withings BPM Pro2 (WPM07) upper‑arm oscillometric BP monitor in the adult general population using the ISO 81060‑2:2018/AMD 2:2024 Universal Standard. Methods: Following the ISO same‑arm sequential measurement protocol, 89 eligible pre-selected participants underwent paired test‑device and mercury reference auscultatory measurements. Nine BP measurements were performed on each participant, four with the tested device and five with the auscultatory method. The accuracy of BP measurements was assessed based on the difference between simultaneous measurements taken by two observers and those displayed by the tested device using ISO Criterion 1 (mean and standard deviation of test-reference differences) and Criterion 2 (within‑subject variability of averaged difference values). Results: Eighty-nine participants underwent the BP measurements protocol, data from 87 were analyzed after excluding 2 participants due to excessive BP variability. Inter‑observer agreement for reference measurements was 0.64 ± 2.14 mmHg for systolic BP (SBP) and 0.39 ± 1.98 mmHg for diastolic BP (DBP). ISO criterion 1 was met with mean test-reference differences of 1.0 ± 4.9 mmHg (SBP) and 0.6 ± 4.1 mmHg (DBP) below ISO requirements (≤ 5±8 mmHg). ISO criterion 2 was also satisfied, with within‑subject standard deviations of 3.50 mmHg (SBP) and 3.01 mmHg (DBP), well below the ISO thresholds (≤6.87/6.91 mmHg). Conclusion: The BPM Pro2 (WPM07) fulfills the ISO 81060‑2:2018/AMD 2:2024 accuracy requirements and is suitable for reliable home BP self‑measurement in adults.

Indexed as

Blood PressureBlood Pressure Monitoring, AmbulatoryBlood Pressure MonitorsOscillometryAdultAgedEquipment DesignFemaleHumansMaleMiddle AgedObserver VariationPredictive Value of TestsReproducibility of ResultsYoung Adultaccuracyblood pressure measurementsbrachialhome blood pressureoscillometricvalidationWithings

Identifiers

PMID41777561
PMCPMC12950639

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