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CytoSorbents Provides U.S. FDA and Health Canada Regulatory Update for DrugSorb-ATR

CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada. DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of st

articleCytosorbents CorporationJuly 2, 20258/company/cytosorbents-crp/news/cytosorbents-provides-u-fda-health-110000221
CytoSorbents Provides U.S. FDA and Health Canada Regulatory Update for DrugSorb-ATR

About this update from Cytosorbents Corporation

[{"type":"text","content":"PRINCETON, N.J., July 2, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on its marketing applications for DrugSorb™-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada.  DrugSorb-ATR is an FDA-designated Breakthrough Device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.","length":658,"tagName":"p"},{"type":"image","alt":"CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)","displaySize":"","headline":null,"caption":"CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":75,"url":"https://media.zenfs.com/en/prnewswire.com/e816e81e0545c7d8b46b753e505911fd"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9fT61Wf2yKPK1NZj2V3AsQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTEzMjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/e816e81e0545c7d8b46b753e505911fd","width":400,"height":75}},"href":"https://mma.prnewswire.com/media/1096384/CytoSorbents_Working_To_Save_Lives_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"U.S. FDA Update:On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the Company's requested supervisory review (administrativ...

More updates from Cytosorbents Corporation

Health CanadaFDAblood purificationU.S. Food and Drug AdministrationThe CompanyCytoSorbentscardiac surgeryblood thinnerBreakthrough Devicecardiac surgeonsintensive care unitCompany