Frequently Asked Questions
CADScor®System Questions
The intended use of CADScor®System is to record heart sounds, i.e., murmurs and vibrations, for calculation of a patient-specific score, the CAD-score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis. We suggest using CADScor®System as a first-line non-invasive diagnostic aid to help rule out significant CAD in patients suspected of stable CAD. This may limit the need for further downstream testing and invasive diagnostic procedures. A patient with a low CAD-score (≤20) is unlikely to have CAD. A patient with an elevated CAD-score (>20) has an increased likelihood of disease and should be followed more closely or referred for further evaluation.
The CADScor®System is approved in Europe (CE-marking) and has been marketed since Q2 2017. FDA De Novo clearance in November 2020.
Currently (beginning of 2022) CADScor®System is used in Denmark, Sweden, Germany, Austria, Switzerland, Luxemburg, UK and USA.
The CADScor®System is a Class IIa device. The patch is a Class I device.
The system will indicate if the battery is low. The battery drain is significant during qualifications. Charging it for 15 minutes is sufficient for a couple of recordings, 30 minutes for approximately 10 recordings.
Guiding the patient during the CAD-score evaluation is essential. Two parts of each recording loop exist, one in which the patient is breathing normally and one in which the patient will hold their breath. No talking (or noisy behavior) can occur during the breath-holding period.
No. The patch contains a specific chip and code that is needed to calibrate the machine and will indicate when the patch has been used.
Dispose of used patches together with other standard clinical waste.
