{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-062097","form_type":"8-K","ticker":"CTSO","cik":"0001175151","company_name":"Cytosorbents Corp","filed_at":"2025-06-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.706822+00:00","generated_at":"2026-05-18T21:57:30.279875+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"CytoSorbents appeals FDA denial of DrugSorb-ATR De Novo request; decision expected ~60 days","bullets":["Appeal filed June 18, 2025 under 21 CFR 10.75; FDA denial letter dated April 25, 2025.","DrugSorb-ATR designed to reduce bleeding risk in CABG patients on Brilinta; had Breakthrough Device Designation.","Supervisory review includes formal hearing with CDRH senior management; final decision typical within 60 days.","Health Canada review remains ongoing; company expects a regulatory decision in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-062097","json":"https://secwatch.observer/filing/0001104659-25-062097.json","markdown":"https://secwatch.observer/filing/0001104659-25-062097.md","text":"https://secwatch.observer/filing/0001104659-25-062097.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/0001104659-25-062097-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1175151/000110465925062097/tm2518791d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T21:57:30.279875+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}