{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-063031","form_type":"8-K","ticker":"TLSI","cik":"0001826667","company_name":"TriSalus Life Sciences, Inc.","filed_at":"2026-09-22T20:14:43+00:00","discovered_at":"2026-09-22T20:16:06.994986+00:00","generated_at":"2026-09-22T20:16:16.529400+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":"TriSalus receives FDA clearance for TriNav Advance liver embolization device","bullets":["FDA 510(k) clearance for TriNav Advance PEDD device announced Sept 22, 2026; limited market release in coming weeks.","TriNav Advance adds small-distal-vessel access via compatible microcatheter; two configurations: telescoping and high-flow.","Expands TriSalus portfolio beyond liver embolization; supports broader range of embolization procedures.","Company now has four FDA-cleared devices: TriNav, TriNav LV, Pancreatic Retrograde, and TriNav Advance."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-063031","json":"https://secwatch.observer/filing/0001628280-26-063031.json","markdown":"https://secwatch.observer/filing/0001628280-26-063031.md","text":"https://secwatch.observer/filing/0001628280-26-063031.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/0001628280-26-063031-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1826667/000162828026063031/tlsi-20260922.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-22T20:16:16.529400+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"}