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The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of presence of coronary stenosis, as an aid in cardiac analysis and diagnosis.

The CADScor System is a digital stethoscope for recording and quantifying acoustic noise from micro-turbulence originating from stenosis of the coronary arteries. Computational processing of a recording obtained from the chest surface of a patient is used to determine a coronary artery disease (CAD) risk score and associated risk classification. Three components make up the CADScor System: the Docking station, the Acoustic Recording Sensor and the Patch. The docking station is responsible for charging and qualifying the sensor. These functionalities only happen when the Acoustic Recording Sensor is in direct contact with the docking station. An LED light indicates the status of the sensor. The Acoustic Recording Sensor contains a display, a microphone and an on/off button. The heart sound is recorded through a microphone and once the CAD risk score is calculated, it appears on the display screen. The patch is directly in contact with the patient's chest at the fourth left inter costal space (IC4-L) region. The patch provides a tight seal between the chest surface and the microphone to reduce the external noise that is picked up by the sensor. The patch is for single use only and is discarded after a CAD-score is calculated. A radiofrequency identification (RFID) tag in the patch is used to prevent the patch from being used more than once. An algorithm is used to calculate a coronary artery disease (CAD) risk score. The algorithm analyzes 8 features of the acoustic recording and three clinical features that are manually inputted into the device by the clinician. The clinical inputs are age, gender and presence of hypertension. The eight acoustic features are put through a linear discriminate analysis and then put through a logistic regression with the clinical features. The risk score and associated categorization color are displayed on the acoustic sensor screen. There are two risk categories: low risk and elevated risk (Figure 2). Clinicians can use the score and categorization to aid in a clinician's determination of whether further testing is needed for a CAD diagnosis.