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Qardio QardioArm A100

Device Name:QardioArm A100
Manufacturer:Qardio Inc., 28 2nd Street, San Francisco, CA 94105, UNITED STATES.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Qardio QardioArm A100, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
BIHS (UK and IRL)Self-measurementPublished evidence
 
Consumer BodyVersionQuartileComment
Consumer Reports (US)2019B 
Amazon Best Sellers (US)2019B (3.4 / 5) 

Validation Publications

Chahine MN, Topouchian J, Zelveian P, Hakobyan Z, Melkonyan A, Azaki A, Diab R, Harb A, Asmar R. Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP). Med Devices (Auckl). 2017 Dec 27;11:11-20. doi: 10.2147/MDER.S142126. PMID: 29343992. Available from: PMC5749560. eCollection 2018.

ESH-IP:2010 - Pass General population

Relevant Publications

Mazoteras Pardo V, Losa Iglesias ME, López Chicharro J, Becerro de Bengoa Vallejo R. The QardioArm App in the Assessment of Blood Pressure and Heart Rate: Reliability and Validity Study. JMIR Mhealth Uhealth. 2017 Dec;5(12):e198. Epub: 2017 Dec 15. doi: 10.2196/mhealth.8458. PMID: 29246880. Available from: PMC5747597.

The reference device used was the Omron M3 (HEM-7200-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.

Mazoteras Pardo V, Becerro de Bengoa Vallejo R, Losa Iglesias ME, López López D, Palomo López P, Rodríguez Sanz D, Calvo Lobo C. The QardioArm Blood Pressure App for Self-Measurement in an Obese Population: Validation Study Using the European Society of Hypertension International Protocol Revision 2010. JMIR Mhealth Uhealth. 2018 Oct;6(10):e11632. Epub: 2018 Oct 25. doi: 10.2196/11632. PMID: 30361193. Available from: PMC6229517.

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.