The technology used in the SunTech CT40, 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.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|BIHS (UK and IRL)||Self-measurement||Published evidence|
|AMA VDL Criteria||General use||510(k) K160439 plus 81060-2:2013 and BHS:1993 validations|
|MDR Criteria||Professional use||Published evidence|
Polo Friz H, Punzi V, Petri F, Orlandi R, Maggiolini D, Polo Friz M, Primitz L, Vighi G. Simultaneous validation of the SunTech CT40 automated blood pressure measurement device by the 1993 British Hypertension Society protocol and the Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2: 2013 standard. Blood Press Monit. 2017 Oct;22(5):298-301. Epub: 2017 July 31. doi: 10.1097/MBP.0000000000000281. PMID: 28763332.
81060-2:2013 - Pass General population
BHS:1993 - Pass (A/A) General population