{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-001800","form_type":"8-K","ticker":"CBLL","cik":"0001861107","company_name":"Ceribell, Inc.","filed_at":"2026-01-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.592211+00:00","generated_at":"2026-05-16T11:42:52.560245+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Ceribell receives FDA Breakthrough Device Designation for LVO stroke detection system","bullets":["FDA Breakthrough Device Designation granted for CeriBell's LVO stroke detection and monitoring solution.","First-in-class point-of-care EEG technology using existing hardware and AI algorithm to interpret signals.","Nearly 800,000 annual US strokes; LVO strokes cause 62% of post-stroke dependence and 96% of mortalities.","Designation supports potential expedited development; follows recent 510(k) clearances for Clarity and delirium screening.","Targets in-hospital stroke patients, where detection and treatment delays lead to 3x higher mortality."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-001800","json":"https://secwatch.observer/filing/0001193125-26-001800.json","markdown":"https://secwatch.observer/filing/0001193125-26-001800.md","text":"https://secwatch.observer/filing/0001193125-26-001800.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861107/000119312526001800/0001193125-26-001800-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861107/000119312526001800/cbll-20260105.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:42:52.560245+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"}