The technology used in the HealthSTATS BPro, 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||Legacy approval||Older clinical validation; older protocol|
|BIHS (UK and IRL)||ABPM||Published evidence|
|AMA VDL Criteria||Satisfies stated criteria||510(k) K060315 plus SP10:2002 validation|
Nair D, Tan SY, Gan HW, Lim SF, Tan J, Zhu M, Gao H, Chua NH, Peh WL, Mak KH. The use of ambulatory tonometric radial arterial wave capture to measure ambulatory blood pressure: the validation of a novel wrist-bound device in adults. J Hum Hypertens. 2008 Mar;22(3):220-2. Epub: 2007 Nov 8. doi: 10.1038/sj.jhh.1002306. PMID: 17992251. Available from: www.nature.com. Reseach Letter.
ESH-IP:2002 - Pass General population (Note: Insufficient detail provided to support result)
Komori T, Eguchi K, Hoshide S, Williams B, Kario K. Comparison of wrist-type and arm-type 24-h blood pressure monitoring devices for ambulatory use. Blood Press Monit. 2013 Feb;18(1):57-62. doi: 10.1097/MBP.0b013e32835d124f. PMID: 23263536.
Measurements from the HealthSTATS BPro are compared to those from the A&D TM-2431, though not in a formal validation.