BPM Core has received CE clearance for medical devices.
The ability of BPM Core to accurately measure blood pressure was validated in a clinical trial of participants representative of the intended population: adults from the general population with an arm range of 22-42 cm (9 to 17 inches) and all grades of blood pressure.
For each participant, 3 measurements were taken and compared with 3 measurements acquired for reference (by Korotkoff method) determined by two trained independent observers.
The mean error is -2.7 mmHg for systolic blood pressure and 1.3 mmHg for diastolic blood pressure, and the standard deviation of the error is 7 mmHg and 5.5 mmHg respectively.
These results are well within the margin of acceptance defined by the internationally recognized evaluation standard of blood pressure monitors ANSI/AAMI/ISO 81060-2:2013, EN ISO 81060-2:2014, developed by the European Society of Hypertension and British Hypertension Society.
The ability of BPM Core to accurately classify an ECG recording into AFib and sinus rhythm was validated in a clinical trial. Rhythm classification from a gold standard 12-lead ECG by a cardiologist was compared to the rhythm classification of an ECG collected from the BPM Core. On the classifiable recordings, the BPM Core demonstrated 92 percent sensitivity in classifying AFib and 98.4 percent specificity in classifying sinus rhythm in classifiable recordings.
The ability of BPM Core to accurately classify a phonocardiogram recording into valvular heart disease and healthy heart valves was validated in a clinical trial. The classification by the BPM Core was compared to the gold standard technique, the diagnostic by a trained cardiologist from a Doppler echocardiography. The sensitivity in classifying grade 3 and 4 VHD is 81.25% and the specificity is 95%. In good conditions, this diagnostic performance by an automated device is comparable to one of a general practitioner using the technique of auscultation. [ref]
Note: A specificity of 95% means that in 5% of the users, the BPM Core will find a VHD where there is none.
[ref] Echocardiography in the evaluation of systolic murmurs of unknown cause
Attenhofer Jost, Christine H et al.
The American Journal of Medicine, Volume 108, Issue 8, 614 - 620