{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-008245","form_type":"8-K","ticker":"IRMD","cik":"0001325618","company_name":"IRADIMED CORP","filed_at":"2025-05-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.920817+00:00","generated_at":"2026-05-20T05:30:35.818880+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"iRadimed receives FDA 510(k) clearance for next-gen MRidium 3870 infusion pump","bullets":["FDA granted 510(k) clearance on May 29, 2025 for the MRidium 3870 IV Infusion Pump System.","Company remains the world's only supplier of non-magnetic MRI infusion pump devices (first device in 2005).","New pump features enhanced touchscreen UI, advanced safety, drug library, and four-channel capability.","Strategic rollout begins with initial units in Q4 2025; full commercial distribution ramps through 2026.","CEO Roger Susi says clearance is a milestone from FDA collaboration on evolving regulatory requirements."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-008245","json":"https://secwatch.observer/filing/0001558370-25-008245.json","markdown":"https://secwatch.observer/filing/0001558370-25-008245.md","text":"https://secwatch.observer/filing/0001558370-25-008245.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1325618/000155837025008245/0001558370-25-008245-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1325618/000155837025008245/irmd-20250529x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T05:30:35.818880+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"}