CytoSorbents (CTSO) issued a regulatory update on its marketing applications for DrugSorb-ATR with the FDA and Health Canada. On June 27, 2025, the FDA confirmed the scheduling of an appeal hearing date for the company's requested supervisory review. The company continues to believe remaining deficiencies in its De Novo Request can be effectively resolved through this supervisory review process. Also, on June 26, 2025, Health Canada issued a Notice of Refusal of the company's Medical Device License application, citing non-compliance with certain Medical Devices Regulations. As part of Health Canada's prescribed reconsideration process, the company intends to file a Level 1 Request for Reconsideration with the Medical Devices Directorate Bureau Director by July 25, 2025.
Phillip Chan, CEO of CytoSorbents, said: "We remain confident in the strength of our regulatory submissions and are committed to working through the appeals processes in a timely manner with both FDA and Health Canada. We continue to expect final regulatory decisions by the end of this year."
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.