CytoSorbents Corporation has filed an administrative appeal with the U.S. Food and Drug Administration (FDA) for a supervisory review of the De Novo Denial Letter issued for its DrugSorb™-ATR device. This device is aimed at minimizing bleeding severity in patients undergoing coronary artery bypass grafting surgery shortly after ceasing the use of the blood thinner Brilinta®. Despite receiving a Breakthrough Device Designation, the FDA has identified certain deficiencies that need to be addressed before commercialization in the U.S. The company's appeal seeks to resolve these issues through engagement with senior FDA leadership. Meanwhile, the DrugSorb-ATR application is under advanced review by Health Canada, although the process is delayed due to a backlog. CytoSorbents remains optimistic about receiving a final regulatory decision in 2025.
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