{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-312035","form_type":"8-K","ticker":"CBLL","cik":"0001861107","company_name":"Ceribell, Inc.","filed_at":"2025-12-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.859274+00:00","generated_at":"2026-05-16T13:50:14.284516+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Ceribell receives FDA 510(k) clearance for first delirium monitoring solution","bullets":["FDA cleared Ceribell's EEG-based delirium screening and monitoring system for critically ill patients.","Algorithm validated in prospective study of 225 adults in critical care; continuous monitoring at bedside.","Delirium affects ~31% of ICU patients and up to 80% of mechanically ventilated; associated with higher mortality and dementia risk.","Ceribell has submitted NTAP application to CMS for the new indication; leverages existing commercial footprint.","CEO Jane Chao expects to finalize go-to-market strategy soon; builds on prior Breakthrough Device Designation (2022)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-312035","json":"https://secwatch.observer/filing/0001193125-25-312035.json","markdown":"https://secwatch.observer/filing/0001193125-25-312035.md","text":"https://secwatch.observer/filing/0001193125-25-312035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861107/000119312525312035/0001193125-25-312035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861107/000119312525312035/cbll-20251209.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:50:14.284516+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"}