Withings BPM Connect Pro (WPM06)

Description:

The Withings BPM Connect Pro (WPM06) is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Withings BPM Connect Pro (WPM06), to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Self-measurement and professional use for adults and pregnancy	Manufacturer declaration of equivalence to the Withings BPM Connect WPM05
BP	Stride BP	Self-measurement for adults and pregnancy (Preferred)	Equivalence to the Withings BPM Connect WPM05 claim without published evidence
BP	AMA VDL (US)	Self-measurement for general use and pregnancy	Equivalence claim without published evidence

Device Family:

Withings BPM Connect (WPM05)B,P, Withings BPM Connect Pro (WPM06)B,P
Legend: B BIHS Derivative, P Stride Equivalence

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Withings BPM Connect (WPM05)

Zelveian P, Topouchian J, Hakobyan Z, Asmar J, Gharibyan H, Asmar R. Clinical Accuracy of the Withings BPM Connect for Self-Blood Pressure Measurements in Pregnancy and Pre-Eclampsia: Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Vasc Health Risk Manag. 2022 Mar 26;18:181-189. doi: 10.2147/VHRM.S351313. PMID: 35370407. Available from: PMC8967988.

81060-2:2019 - Pass Normotensive pregnancy (n=15), Gestational hypertensive pregnancy (n=15), Pre-eclampsia (n=15)

Topouchian J, Zelveian P, Hakobyan Z, Gharibyan H, Asmar R. Accuracy of the Withings BPM Connect Device for Self-Blood Pressure Measurements in General Population - Validation According to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Vasc Health Risk Manag. 2022 Mar 31;18:191-200. doi: 10.2147/VHRM.S350006. PMID: 35386428. Available from: PMC8979570.

81060-2:2019 - Pass General population