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FDA identifies exclusive code for the CADScor®System

 

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.

 

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About Acarix
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, certifiedadviser@redeye.se) is Certified Advisor of Acarix.

For more information, please visit www.acarix.com.