Acarix - The de novo beat
Acarix has announced that the FDA is reviewing a de novo 510(k) application for its innovative CADScor cardiac diagnostic device. This is important news as it could mean that Acarix might enter the US market by 2021 – although it will need marketing alliances and good reimbursement. Given weak European sales and no update on German reimbursement, accessing the large US market could radically transform the business. Acarix might need US clinical data to ensure that it gains Medicare and insurer reimbursement.Acarix AB is a Sweden-based provider of diagnostic solutions for coronary artery disease (CAD). The Company's primary product CADScor System features phonocardiography technique and algorithms. The CADScor System is fixed with a specific patch to the chest of the patient, with the recording head placed at the forth left intercostal space, and the sensor resting on the sternum. Instructions for the procedure are given on the display for the operator and audio cues guide a patient during the two-minute heart sound recording. After recording, the CAD-score is calculated, and presented on the display of the CADScor Sensor, enabling a physicians, nurses and laboratory technicians to make a rule-out diagnosis.
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