07:42 AM EDT, 07/02/2025 (MT Newswires) -- CytoSorbents ( CTSO ) said Wednesday that the US Food and Drug Administration has confirmed an appeal hearing date for its requested supervisory review of DrugSorb-ATR's marketing application.

DrugSorb-ATR is a device designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery.

The company said it believes the remaining deficiencies in its application can be addressed through this review process, which is scheduled to be completed by the end of next month.

Also on Wednesday, CytoSorbents Health Canada has issued a notice of refusal for the company's medical device license application due to non-compliance with certain regulations.

CytoSorbents ( CTSO ) said it plans to file a request for reconsideration by July 25.