{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-004411","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2024-01-31T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.174326+00:00","generated_at":"2026-06-06T13:15:02.818177+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"InspireMD Receives CE Mark Recertification Under EU MDR for CGuard Stent System","bullets":["CE Mark recertification under EU's new Medical Device Regulation (MDR) obtained.","CGuard EPS can continue to be marketed in existing EU territories.","U.S. C-GUARDIANS IDE trial primary endpoint results expected mid-2024.","Final module of PMA submission to FDA planned for second half of 2024.","Potential U.S. approval of CGuard Prime EPS stent system in first half of 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-004411","json":"https://secwatch.observer/filing/0001493152-24-004411.json","markdown":"https://secwatch.observer/filing/0001493152-24-004411.md","text":"https://secwatch.observer/filing/0001493152-24-004411.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/0001493152-24-004411-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-06T13:15:02.818177+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"}