{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-292140","form_type":"8-K","ticker":"CBLL","cik":"0001861107","company_name":"Ceribell, Inc.","filed_at":"2025-11-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.859038+00:00","generated_at":"2026-05-16T17:22:09.545127+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 Clarity algorithm to detect seizures in neonates","bullets":["FDA clearance covers use of Clarity algorithm for electrographic seizure detection in newborns preterm and older through adults, the first AI-powered point-of-care EEG for all ages.","Clearance supported by EEG data from over 700 patients, the largest known validation dataset for a neonatal seizure detection system.","Approximately 9% of NICU patients may have seizures, but up to 90% go undetected without EEG monitoring, per the release.","Ceribell previously received 510(k) clearance for a headcap optimized for the neonatal population.","CEO Jane Chao cited the clearance as expanding availability of rapid, AI-powered neurological monitoring to more patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-292140","json":"https://secwatch.observer/filing/0001193125-25-292140.json","markdown":"https://secwatch.observer/filing/0001193125-25-292140.md","text":"https://secwatch.observer/filing/0001193125-25-292140.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861107/000119312525292140/0001193125-25-292140-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861107/000119312525292140/cbll-20251124.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T17:22:09.545127+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"}