{"schema_version":"secwatch.filing_event.v1","accession":"0001641172-25-014986","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2025-06-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.281265+00:00","generated_at":"2026-05-19T07:55:32.716694+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"InspireMD receives CE Mark approval for CGuard Prime EPS under EU MDR","bullets":["CE Mark approval under European Medical Device Regulation (MDR) for CGuard Prime Embolic Prevention System.","Product designed with MicroNet mesh to reduce embolic events and prevent stroke.","Approval clears path for commercial launch in current CE-marked served markets.","Same platform intended for US launch later in 2025, subject to FDA approval.","CEO Marvin Slosman highlights regulatory milestone and next-generation platform advancement."],"urls":{"canonical":"https://secwatch.observer/filing/0001641172-25-014986","json":"https://secwatch.observer/filing/0001641172-25-014986.json","markdown":"https://secwatch.observer/filing/0001641172-25-014986.md","text":"https://secwatch.observer/filing/0001641172-25-014986.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000164117225014986/0001641172-25-014986-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000164117225014986/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T07:55:32.716694+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"}