Senbiosys SBF2003

Description:

The Senbiosys SBF2003 is an automatic blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

The technology used in the Senbiosys SBF2003, to measure blood pressure, has been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

Schukraft S, Haddad S, Faucherre Y, Arroyo D, Togni M, Barison A, Boukhayma A, Cook S, Caizzone A. Remote blood pressure monitoring with a wearable photoplethysmographic device in patients undergoing coronary angiography: the senbiosys substudy. Blood Press Monit. 2022 Dec 1;27(6):402-407. Epub: 2022 Aug 8. doi: 10.1097/MBP.0000000000000615. PMID: 35950543. Available from: PMC9632946.

Ad Hoc protocol Special Circumstances

This validation was carried out by the device developers; it is not independent.

Relevant Publications:

Schukraft S, Boukhayma A, Cook S, Caizzone A. Remote Blood Pressure Monitoring With a Wearable Photoplethysmographic Device (Senbiosys): Protocol for a Single-Center Prospective Clinical Trial. JMIR Res Protoc. 2021 Oct 7;10(10):e30051. doi: 10.2196/30051. PMID: 34617912. Available from: PMC8532013.