Business
CytoSorbents Updates U.S. FDA Regulatory Status of 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, updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authorization of DrugSorb™-ATR.
About this update from Cytosorbents Corporation
[{"type":"text","content":"FDA appeal decision found no issues with DrugSorb-ATR device safety but upheld the De Novo denial, and proposes a potential path forward for market authorization ","length":161,"tagName":"p","attribs":{}},{"type":"text","content":"PRINCETON, N.J., Aug. 20, 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, updates the regulatory status of its appeal with the U.S. Food and Drug Administration (FDA) for De Novo market authorization of DrugSorb™-ATR.","length":361,"tagName":"p"},{"type":"image","alt":"CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is seeking U.S. FDA and Health Canada 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 in the intensive care unit and cardiac surgery using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is seeking U.S. FDA and Health Canada marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":185,"url":"https://media.zenfs.com/en/prnewswire.com/60064ee123b2486ff06bf22679aad801"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Vyx_W5YQZ5KQRkzzHXw_Kg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTMyNjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/60064ee123b2486ff06bf22679aad801","width":400,"height":185}},"href":"https://mma.prnewswire.com/media/2754298/CytoSorbents_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"On August 14, 2025, the Company received an FDA appeal decision following its July 2025 in-person supervisory administrative review (appeal) meeti...