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CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR
CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSorb-ATR, which previously received B
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[{"type":"text","content":"PRINCETON, N.J., June 24, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced that on June 18, 2025, it filed a request for supervisory review (administrative appeal) with the U.S. Food and Drug Administration (FDA) under 21 CFR 10.75, of the De Novo Denial Letter issued on April 25, 2025 for CytoSorbents' DrugSorb-ATR Device, (the denial letter). DrugSorb-ATR, which previously received Breakthrough Device Designation from the FDA, is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within two days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.","length":852,"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":"n...