SENSICARDIAC
DIACOUSTIC MEDICAL (PTY)SensiCardiac is a software device designed to record, analyze, and interpret heart sounds captured by an electronic stethoscope. It assists clinicians by distinguishing between normal and pathological heart murmurs, identifying specific heart sounds such as S1, S2, and murmurs. This helps provide supportive information during heart examinations in clinical settings.
Intended Use
The SensiCardiac is an electronic auscultatory device intended to support physicians in evaluation of patients' heart sounds by acquiring, recording, and analyzing acoustic signals of the heart to identify specific sounds including suspected murmurs.
Technology
The device is a software package running on a Windows PC that interfaces with compatible electronic stethoscopes to acquire acoustic heart sound signals in standardized .wav files. It analyzes these signals using signal processing and classification algorithms to detect heart sounds and murmurs at the four main auscultation positions.
Performance
Performance testing included software validation, usability studies in clinical settings by intended users, and comparative studies showing that SensiCardiac's classification accuracy and clinical performance are comparable to predicate devices, with reported accuracy around 68-70%, specificity 95%, and sensitivity 84%.
Predicate Devices
No predicate devices specified
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