After yesterday’s announcement and further analysis of the FDA approval,Acarix AB today announce that the company’s marketing approval of the CADScor®System in the US was granted under a new generic type of code and device segment by the US Food and Drug Administration (FDA). The code covers Coronary artery disease risk indicator using acoustic heart signals. Acarix is the sole company in the market that has been granted this label.
Acarix was establish in 2009 and is listed on Nasdaq First North Growth Market. Acarix's CADScor@System uses an advanced sensor placed on the skin above the heart to listen to the sounds of cardiac contraction movement and turbulent flow. It has been designed to be an all-in-on system in the sense that the heart signal will be recorded, processed, and displayed as a patient specific score, the CAD-score, on the device screen.