SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.SensiCardiac Mobi is a decision support software that records and analyzes heart sounds captured by an electronic stethoscope to distinguish normal and pathological heart murmurs. It supports clinicians by providing analysis of heart acoustic signals, identifying heart sounds such as S1, S2, and murmurs to aid in clinical evaluation.
Intended Use
The SensiCardiac Mobi is an electronic auscultatory device intended to provide support to physicians in evaluating patients' heart sounds by acquiring, recording, and analyzing acoustic signals to identify specific heart sounds (S1, S2, and suspected murmurs). It is indicated for clinical use by physicians or trained personnel and is not intended as a sole diagnostic tool.
Technology
An AI software application consisting of the Sensi Diagnostic Heart Murmur Algorithm running in a hosted Linux server environment. It interfaces with a handheld mobile device (iPhone 4S or later) that captures and transfers electronic stethoscope audio signals for analysis. The electronic stethoscope records acoustic heart sounds at 20 Hz to 10,000 Hz, sampling >4,000 Hz, and stores them in .wav files for algorithmic analysis to identify heart sounds and murmurs.
Performance
The device was validated through software verification and validation, usability studies including real-life clinical testing, and bench acoustic performance tests. It demonstrated high specificity (94%) and sensitivity (84%) relative to echocardiography (gold standard) on a pediatric cardiac dataset. The graphical user interface was favorably compared to the predicate device, and acoustic performance on iPhone 4S/5 was found more than adequate. No new safety or effectiveness issues were identified.
Predicate Devices
No predicate devices specified
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