CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Busines...
Cytosorbents Corporation (CTSO)
Last cytosorbents corporation earnings: 11/5 04:15 pm
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Source: GlobeNewswire
The De Novo medical device application for DrugSorb™-ATR is eligible for FDA priority review as an FDA Breakthrough Designated Device for this indicationThe Health Canada Medical Device License application is ready for submission, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near futureExpecting FDA and Health Canada decisions in 2025 PRINCETON, N.J., Oct. 01, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces the submission of its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024, to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The FDA has previously granted Breakthrough Device Designation to
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News
- CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP CertificationGlobeNewswire
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
- FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive ReviewGlobeNewswire
- CytoSorbents to Report Third Quarter 2024 Operating and Financial ResultsGlobeNewswire
CTSO
Earnings
- 8/13/24 - Beat
CTSO
Analyst Actions
- 8/14/24 - HC Wainwright
CTSO
Sec Filings
- 10/8/24 - Form 4
- 10/8/24 - Form 4
- 10/1/24 - Form 8-K
- CTSO's page on the SEC website