

Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | ★★ Recommendation | Recent clinical validation; recent protocol |
Pellaton C, Vybornova A, Fallet S, Marques L, Grossenbacher O, De Marco B, Chapuis V, Bertschi M, Alpert BS, Solà J. Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements. Blood Press Monit. 2020 Apr;25(2):105-109. Epub: 2019 Oct. doi: 10.1097/MBP.0000000000000421. PMID: 31688003.
IA protocol General population
Vybornova A, Polychronopoulou E, Wurzner-Ghajarzadeh A, Fallet S, Sola J, Wuerzner G. Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. Blood Press Monit. 2021 Aug 1;26(4):305-311. Epub: 2021 Mar 4. doi: 10.1097/MBP.0000000000000531. PMID: 33675592.
81060-2:2013 - Pass General population (Note: Seated position (other positions to follow). 14% with SBP ≥ 140 mmHg less than 20% required by protocol. Skin pigmentation and hair follicle density characteristics added.)
Sola J, Vybornova A, Fallet S, Polychronopoulou E, Wurzner-Ghajarzadeh A, Wuerzner G. Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. Sci Rep. 2021 Oct 19;11(1):20644. doi: 10.1038/s41598-021-99294-w. PMID: 34667230. Available from: PMC8526831.
81060-2:2013 - Pass General population (Note: Seated position (hand at heart level))
81060-2:2013 - Fail General population (Note: Supine position (Fail/Pass))
81060-2:2013 - Pass General population (Note: Seated position (hand on lap))
81060-2:2013 - Fail General population (Note: Standing position (Fail/Fail))
Extention of previous study
Sola J, Vybornova A, Fallet S, Olivero E, De Marco B, Grossenbacher O, Ignjatovic N, Ignjatovic B, Favre-Bulle M, Levinson N, Siutryk N, Chapuis V, Bertschi M, Alpert B. Are cuffless devices challenged enough? Design of a validation protocol for ambulatory blood pressure monitors at the wrist: the case of the Aktiia Bracelet. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul:4437-4440. doi: 10.1109/EMBC44109.2020.9176286. PMID: 33018979.
Protocol for assessing wristband devices.