The technology used in the VivaChek Ino, to measure blood glucose, 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|
|MDR Criteria||Self-measurement||Published evidence|
Hehmke B, Berg S, Salzsieder E. Accuracy Evaluation of a CE-Marked Glucometer System for Self-Monitoring of Blood Glucose With Three Reagent Lots Following ISO 15197:2013. J Diabetes Sci Technol. 2017 May;11(3):635-6. Epub: 2016 Oct 4. doi: 10.1177/1932296816670401. PMID: 27707915. Available from: PMC5505413.
15197:2013 - Pass General population