Acarix AB (publ) (ACARIX: FN Stockholm) today announced the submission of a De Novo application to the American Food and Drug Administration (FDA) for the CADScor® System in preparation of a US market entry. The company is now cautiously initiating preparations for market launch.
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.