iHealth View (BP7S)

Description:

The iHealth View (BP7S) 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 wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the iHealth View (BP7S), 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	Manufacturer declaration of equivalence to the iHealth Sense BP7 (KD-972)
BP	Stride BP	Self-measurement for adults	Equivalence to the iHealth Sense BP7 (KD-972) claim without published evidence

	Consumer Body	Year(s)	Level	Comment
BP	Consumer Reports (US)	Latest: 2018-2021	Good
BP	Choice (Australia)	Previous: 2019	B

Device Family:

Andon KD-723P, iHealth Sense BP7 (KD-972)B,P, iHealth View (BP7S)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.

iHealth Sense BP7 (KD-972)

Wang Q, Zhao H, Chen W, Li N, Wan Y. Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Feb;19(1):54-7. doi: 10.1097/MBP.0000000000000017. PMID: 24361919.

ESH-IP:2010 - Pass General population

Li Y, Zhu Z, Li J, Gu Y, Wan Y. Clinical evaluation of the iHealth BP7 wrist blood pressure monitor in general population according to the ISO 81060-2:2018/Amd 1:2020. Blood Press Monit. Epub: 2025 Feb 25. doi: 10.1097/MBP.0000000000000746. PMID: 40013503.

81060-2:2020 - Pass General population