The technology used in the A&D TM-2441, 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|
|MDR Criteria||ABPM||Published evidence|
Kario K, Hoshide S, Saito K, Sato K, Hamasaki H, Suwa H, Tomitani N. Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2 2013 standard. Blood Press Monit. 2019 Feb;24(1):38-41. Epub: 2019 Nov 29. doi: 10.1097/MBP.0000000000000357. PMID: 30507622.
81060-2:2013 - Pass General population (Note: Primary 85-subject study)
81060-2:2013 - Pass General population (Note: 35-subject exercise study, as required for ABPM devices)
Both the main and exercise studies are completed; 13 subjects were included in both studies.