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Biospectal OptiBP
Manufacturer:
Biospectal SA, Chemin des Allinges 3, 1006 Lausanne, SWITZERLAND.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Biospectal OptiBP is a blood pressure app. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the finger and it is intended for self-measurement and home use.
Assessment:
The technology used in the Biospectal OptiBP, to measure blood pressure, has passed in clinical validation studies, in general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
Medaval ★★ Recommendation Recent clinical validation; recent protocol
BIHS (UK and IRL) NOT recommended Published evidence
MDR Criteria Self-measurement Published evidence
Validation Publications:

Schoettker P, Degott J, Hofmann G, Proença M, Bonnier G, Lemkaddem A, Lemay M, Schorer R, Christen U, Knebel JF, Wuerzner A, Burnier M, Wuerzner G. Blood pressure measurements with the OptiBP smartphone app validated against reference auscultatory measurements. Sci Rep. 2020 Oct 20;10(1):17827. doi: 10.1038/s41598-020-74955-4. PMID: 33082436. Available from: PMC7576142.

81060-2:2019 n=40 (Note: The sample size of 40 subjects is well below the 85-subjects requirement. Only Criterion 1 results are provided. Distribution requirements according to the protocol are not provided. The SBP SD of 7.7 mmHg is very close to the passing limit of 8 mmHg and no assumtions can be made regarding Criterion 2 or how the algorithm would fare in a full validation.)

Degott J, Ghajarzadeh-Wurzner A, Hofmann G, Proença M, Bonnier G, Lemkaddem A, Lemay M, Christen U, Knebel JF, Durgnat V, Michel B, Wuerzner G, Schoettker P. Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol. Blood Press Monit. 2021 Dec 1;26(6):441-448. Epub: 2021 Jun 15. doi: 10.1097/MBP.0000000000000556. PMID: 34139747.

81060-2:2019 - Pass n=91 (Note: The Criterion 1 SBP SD of 7.7 mmHg is very close to the passing limit of 8 mmHg.)

Caillat M, Degott J, Wuerzner A, Proençain M, Bonnier G, Knebel JF, Stoll C, Christen U, Durgnat V, Hofmann G, Burnier M, Wuerzner G, Schoettker P. Accuracy of blood pressure measurement across BMI categories using the OptiBP™ mobile application. Blood Press. 2022 Dec;31(1):288-296. doi: 10.1080/08037051.2022.2132214. PMID: 36266938.

81060-2:2019 - Pass Normal weight subjects, BMI < 25 kg/m² (n=46)

81060-2:2019 - Pass Overweight subjects, BMI 25 kg/m² to < 30 kg/m² (n=34)

81060-2:2019 - Fail Obese subjects, BMI ≥ 30 kg/m² (n=15)

ISO validation is claimed but is reported separately for three groups with insufficient respective sample sizes.

Relevant Publications:

Desebbe O, Tighenifi A, Jacobs A, Toubal L, Zekhini Y, Chirnoaga D, Collange V, Alexander B, Knebel JF, Schoettker P, Joosten A. Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. J Clin Monit Comput. Epub: 2021 Aug 18. doi: 10.1007/s10877-021-00749-2. PMID: 34409513.

Measurements from the Biospectal OptiBP are compared to those from automated oscillometric measurements, though not in a formal validation.

Desebbe O, El Hilali M, Kouz K, Alexander B, Karam L, Chirnoaga D, Knebel JF, Degott J, Schoettker P, Michard F, Saugel B, Vincent JL, Joosten A. Evaluation of a new smartphone optical blood pressure application (OptiBP™) in the post-anesthesia care unit: a method comparison study against the non-invasive automatic oscillometric brachial cuff as the reference method. J Clin Monit Comput. Epub: 2022 Jan 3. doi: 10.1007/s10877-021-00795-w. PMID: 34978654.

Measurements from the Biospectal OptiBP are compared to those from automated oscillometric measurements, though not in a formal validation.

Desebbe O, Anas C, Alexander B, Kouz K, Knebel JF, Schoettker P, Creteur J, Vincent JL, Joosten A. Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0. PMID: 35971072. Available from: PMC9376576.

Measurements from the Biospectal OptiBP are compared to those from intra-arterial measurements, though not in a formal validation.