iHealth Track (KN-550BT)
|Medaval||Recommended for pregnancy only||Validation in pregnancy|
|BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
|ESH (Europe)||Self-measurement||The BIHS recommendation, despite the absence of scientific evidence according to the same authors' criteria.|
Van Den Heuvel JFM, Lely AT, Franx A, Bekker MN. Validation of the iHealth Track and Omron HEM-9210T automated blood pressure devices for use in pregnancy. Pregnancy Hypertens. 2019 Jan. 37-41 p. doi: 10.1016/j.preghy.2018.10.008. PMID: 30825925.
ESH-IP:2010 - Pass Pregnancy (n=33) including pre-eclampsia (n=10)
Mazoteras-Pardo V, Becerro-De-Bengoa-Vallejo R, Losa-Iglesias ME, López-López D, Palomo-López P, Rodríguez-Sanz D, Calvo-Lobo C. Validation in the General Population of the iHealth Track Blood Pressure Monitor for Self-Measurement According to the European Society of Hypertension International Protocol Revision 2010: Descriptive Investigation. JMIR Mhealth Uhealth. 2019 Mar 19;7(3):e13137. doi: 10.2196/13137. PMID: 30888331. Available from: PMC6444211.
The reference device used was the Omron M3 Intellisense (HEM-7051-E). However, this is a major and fundamental violation of the protocol requirements. Despite its claims, this study is simply a comparison of two devices and cannot be considered as a validation according to the ESH-IP protocol.