{"schema_version":"secwatch.filing_event.v1","accession":"0001378325-26-000045","form_type":"8-K","ticker":"CV","cik":"0001378325","company_name":"CapsoVision, Inc","filed_at":"2026-09-28T15:03:33+00:00","discovered_at":"2026-09-28T15:04:33.208100+00:00","generated_at":"2026-10-12T13:33:33.307391+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"CapsoVision wins FDA clearance for AI Highlights, its AI-assisted reading tool for CapsoCam Plus","bullets":["FDA cleared AI Highlights on September 25, 2026; CapsoVision announced the clearance on September 28, 2026.","Tool marks suspected abnormal lesions in small bowel capsule endoscopy studies for adults and pediatric patients over age two with suspected small bowel bleeding.","Aims to cut physician review time; integrates with CapsoView review software and CapsoCloud workflows without a separate AI platform.","AI Highlights launched internationally earlier in 2026, including the EU under Medical Device Regulation, per CEO Johnny Wang.","Company notes the tool is not intended to replace gastroenterologists' diagnostic interpretation or histopathological sampling."],"urls":{"canonical":"https://secwatch.observer/filing/0001378325-26-000045","json":"https://secwatch.observer/filing/0001378325-26-000045.json","markdown":"https://secwatch.observer/filing/0001378325-26-000045.md","text":"https://secwatch.observer/filing/0001378325-26-000045.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1378325/000137832526000045/0001378325-26-000045-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1378325/000137832526000045/cv-20260925.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:33:33.307391+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"}