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 is a Swedish medical device company that innovates solutions for rapid AI-based rule out of Coronary Artery Disease (CAD). The CE approved and FDA DeNovo cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive and costly diagnostic procedures. The CADScor system calculates a patient-specific CAD-score non-invasively in less than10 minutes and can help rule out more than one third of patients with at least 96% certainty of not being sick (in a population with approx. 10% CAD prevalence). Acarix is listed on the Nasdaq First North Premier Growth Market (ticker: ACARIX). Redeye AB (+46 (0)8 121 576 90, email@example.com) is Certified Advisor of Acarix.