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Aktiia Bracelet
Manufacturer:
Aktiia SA, Rue de la Maladière 71C, 2002 Neuchâtel, SWITZERLAND.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Wrist
Measurement Occurrence:
Continuous measurement
Availability:
Available Currently
Device Manual:
Description:
The Aktiia Bracelet is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the wrist and it is intended for ambulatory blood pressure monitoring.
Assessment:
The technology used in the Aktiia Bracelet, 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★ Recommendation Recent clinical validation; recent protocol
Validation Publications:

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

Relevant Publications:

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.