CytoSorbents Submits Health Canada Medical Device License Application for DrugSorb-ATR Following MDSAP Certification
Cytosorbents Corporation (CTSO)
Last cytosorbents corporation earnings: 11/5 04:15 pm
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Source: GlobeNewswire
Targets the reduction in CABG-related bleeding severity due to the blood thinning drug, ticagrelor – a major unmet medical need in heart attack patients requiring surgerySuccessful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if requiredHealth Canada and U.S. FDA regulatory decisions expected in 2025 PRINCETON, N.J., Nov. 04, 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, today announced the submission of its DrugSorb™-ATR Medical Device License (MDL) application to Health Canada on November 1, 2024, concurrent with receipt of its Medical Device Single Audit Program (MDSAP) certification. DrugSorb-ATR, an investigational medical device, targets the ability to allow safe and timely coronary artery bypass graft (CABG) surgery in patients
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News
- 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
- Cytosorbents Co. (NASDAQ: CTSO) is now covered by analysts at StockNews.com. They set a "hold" rating on the stock.MarketBeat
CTSO
Earnings
- 8/13/24 - Beat
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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