CytoSorbents (CTSO) issued a regulatory update on DrugSorb-ATR. The company has decided to not file a final appeal with CDRH because of positive FDA upper management feedback for a reasonable path forward that would allow for a suitable and potentially expedited De Novo grant for the company's original desired label indication. The company plans to file a new De Novo application with additional information that includes analyses of new real-world data to support its desired label indication.
The company plans to file a pre-submission meeting request with supporting documentation to the FDA next month. A formal meeting with the Agency is anticipated in fourth quarter of 2025 to confirm the requirements for the new De Novo submission. A standard regulatory decision is expected in mid-2026 following a timely De Novo submission and a typical 150-day review process.
The company had previously filed a Level 1 Request For Reconsideration with Health Canada. The company has withdrawn the Request for Reconsideration and will provide a new Medical Device License application to Health Canada with improved visibility from the FDA.
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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.