The FDA Has Accepted Cytosorbents' De Novo Medical Device Application For DrugSorb-ATR And Initiated Substantive Review, The Company Anticipates An FDA Decision In 2025
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Cytosorbents' De Novo medical device application for DrugSorb-ATR has been accepted by the FDA, with a decision expected in 2025. The device aims to reduce bleeding in patients on ticagrelor undergoing CABG surgery.
October 22, 2024 | 11:20 am
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Cytosorbents' DrugSorb-ATR application has been accepted by the FDA, with a decision anticipated in 2025. This marks a significant step in the regulatory process for the device aimed at reducing bleeding in CABG surgery patients.
The acceptance of the De Novo application by the FDA is a positive regulatory milestone for Cytosorbents, indicating progress towards potential market approval. This could positively impact investor sentiment and the stock price in the short term.
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