{"schema_version":"secwatch.filing_event.v1","accession":"0001688757-24-000084","form_type":"8-K","ticker":"ESTA","cik":"0001688757","company_name":"ESTABLISHMENT LABS HOLDINGS INC.","filed_at":"2024-09-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.117339+00:00","generated_at":"2026-05-31T01:35:45.092214+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA approves Motiva SmoothSilk implants for breast augmentation; first new PMA since 2013","bullets":["FDA approval for Motiva SmoothSilk Ergonomix and Round implants in primary and revision breast augmentation.","Three-year clinical trial data: capsular contracture 0.5%, rupture 0.6%, infection 0.9% in primary augmentation cohort.","First new breast implant PMA approved by FDA since 2013; nearly 4 million Motiva devices already delivered in 85+ countries.","CEO Juan José Chacón-Quirós calls approval transformative for U.S. breast aesthetics, citing differentiated technology.","Study conducted at 32 U.S. and 3 European centers; patient compliance at 92.4% at 3-year endpoint."],"urls":{"canonical":"https://secwatch.observer/filing/0001688757-24-000084","json":"https://secwatch.observer/filing/0001688757-24-000084.json","markdown":"https://secwatch.observer/filing/0001688757-24-000084.md","text":"https://secwatch.observer/filing/0001688757-24-000084.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000084/0001688757-24-000084-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1688757/000168875724000084/esta-20240926.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T01:35:45.092214+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"}