{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-113506","form_type":"8-K","ticker":"TELA","cik":"0001561921","company_name":"TELA Bio, Inc.","filed_at":"2026-10-05T12:05:26+00:00","discovered_at":"2026-10-05T12:10:00.151617+00:00","generated_at":"2026-10-12T14:45:07.915557+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":"TELA Bio wins FDA 510(k) clearance for Liora fully resorbable surgical mesh","bullets":["FDA granted 510(k) clearance for Liora Monofilament Scaffold, a fully resorbable synthetic surgical mesh for soft tissue reinforcement.","Liora is the first implant fully developed in TELA Bio's ISO 8 certified cleanroom in Malvern, PA, and the first fully resorbable synthetic product in its portfolio.","CEO Heather Getz called the clearance 'a significant milestone' that expands options for surgeons and patients in soft tissue reconstruction.","Company says Liora expands its footprint in the soft tissue reconstruction market; more details to come on the Q3 earnings call expected in early November."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-113506","json":"https://secwatch.observer/filing/0001104659-26-113506.json","markdown":"https://secwatch.observer/filing/0001104659-26-113506.md","text":"https://secwatch.observer/filing/0001104659-26-113506.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1561921/000110465926113506/0001104659-26-113506-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1561921/000110465926113506/tm2627013d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:45:07.915557+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"}