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

Theiler K, Sola J, Damianaki A, Pfister A, Almeida TP, Alexandre J, Vermare P, Wuerzner G. Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions. Blood Press. 2023 Dec;32(1):2281320. Epub: 2023 Nov 16. doi: 10.1080/08037051.2023.2281320. PMID: 37971487.

81060-2:2019 - Unconfirmed Pass due to protocol violations Elderly (Note: Sitting position: 175 pairs of measurements (5 per participant).)

81060-2:2019 Elderly (Note: Supine position: 36 pairs of measurements (1.0 per participant).)

81060-2:2019 Elderly (Note: Standing position: 24 pairs of measurements (0.7 per participant).)

EN ISO 81060-2 special patient population (35 participants). Limb distributions and differences in reference pressures per participant are not reported.

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.

Tan I, Gnanenthiran SR, Chan J, Kyriakoulis KG, Schlaich MP, Rodgers A, Stergiou GS, Schutte AE. Evaluation of the ability of a commercially available cuffless wearable device to track blood pressure changes. J Hypertens. 2023 Jun 1;41(6):1003-1010. Epub: 2023 Apr 3. doi: 10.1097/HJH.0000000000003428. PMID: 37016925. Available from: PMC10158604.

The autors concluded that this cuffless wearable device did not track night-time BP decline accurately and that the results suggested it was unable to track medication-induced BP changes.