{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-040673","form_type":"8-K","ticker":"ADGM","cik":"0002006986","company_name":"Adagio Medical Holdings, Inc.","filed_at":"2026-04-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.373219+00:00","generated_at":"2026-05-15T06:56:39.475458+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":"Adagio Medical receives FDA IDE approval to study next-gen vCLAS ventricular ablation system","bullets":["FDA grants IDE approval to expand FULCRUM-VT trial for next-gen vCLAS ULTA Ventricular Ablation System treating SMVT.","System achieves ~ -170°C for single-freeze lesions with >50% reduction in ablation time vs prior models.","Prospective, single-arm, multi-center sub-study of up to 55 patients for scar-mediated SMVT.","Next-gen vCLAS Ultra catheter designed for improved maneuverability, shorter freeze times, and scalability.","Goal is a single versatile catheter treating full VT range via endocardial approach on established ULTA platform."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-040673","json":"https://secwatch.observer/filing/0001104659-26-040673.json","markdown":"https://secwatch.observer/filing/0001104659-26-040673.md","text":"https://secwatch.observer/filing/0001104659-26-040673.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2006986/000110465926040673/0001104659-26-040673-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2006986/000110465926040673/tm2611362d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:56:39.475458+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"}