{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-039640","form_type":"8-K","ticker":"NSPR","cik":"0001433607","company_name":"InspireMD, Inc.","filed_at":"2024-10-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.438313+00:00","generated_at":"2026-05-30T19:09:30.264224+00:00","sec_items":["7.01","8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA approves IDE for InspireMD's CGUARDIANS II pivotal study of CGuard Prime 80cm stent system","bullets":["FDA approved IDE application for CGUARDIANS II pivotal study of CGuard Prime 80cm Carotid Stent System during TCAR procedures.","Study intended to facilitate approval of CGuard Prime for TCAR indication; U.S. commercial sales after approval.","Co-principal investigators: Patrick Geraghty, M.D. (Washington Univ.) and Patrick Muck, M.D. (Good Samaritan Hospital).","Company also advancing development of next-generation TCAR neuroprotection system, SwitchGuard NPS."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-039640","json":"https://secwatch.observer/filing/0001493152-24-039640.json","markdown":"https://secwatch.observer/filing/0001493152-24-039640.md","text":"https://secwatch.observer/filing/0001493152-24-039640.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/0001493152-24-039640-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1433607/000149315224039640/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T19:09:30.264224+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"}