{"schema_version":"secwatch.filing_event.v1","accession":"0001378325-25-000043","form_type":"8-K","ticker":"CV","cik":"0001378325","company_name":"CapsoVision, Inc","filed_at":"2025-12-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.262115+00:00","generated_at":"2026-05-16T12:05:19.761685+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"CapsoVision submits 510(k) to FDA for AI-assisted reading module for CapsoCam Plus","bullets":["Submitted 510(k) to FDA for proprietary AI-assisted module for CapsoCam Plus capsule endoscopy system.","AI module designed to improve detection of clinically significant pathology and reduce clinician review time.","Company plans to commence U.S. commercialization following FDA clearance.","CapsoVision claims it is the only capsule endoscopy company with in-house AI core competency.","Cloud-based architecture eliminates need for on-site servers, reducing cost and IT maintenance."],"urls":{"canonical":"https://secwatch.observer/filing/0001378325-25-000043","json":"https://secwatch.observer/filing/0001378325-25-000043.json","markdown":"https://secwatch.observer/filing/0001378325-25-000043.md","text":"https://secwatch.observer/filing/0001378325-25-000043.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1378325/000137832525000043/0001378325-25-000043-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1378325/000137832525000043/cv-20251229.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:05:19.761685+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"}