{"schema_version":"secwatch.filing_event.v1","accession":"0000898432-22-000616","form_type":"8-K","ticker":"IRMD","cik":"0001325618","company_name":"IRADIMED CORP","filed_at":"2022-10-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:50.135871+00:00","generated_at":"2026-06-23T04:17:51.823936+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Iradimed withdraws 510(k) for MRidium 3870 pump; Q3 revenue $13.4M beats guidance","bullets":["Voluntarily withdrew 510(k) for MRidium 3870 Infusion Pump on Oct 5; plans to resubmit after FDA talks.","Preliminary Q3 revenue ~$13.4M, up 23% YoY, above guidance of $13.1–$13.3M.","Record quarterly revenue; fourth consecutive record quarter; orders exceeded shipments.","Domestic orders for current MRidium 3860 system were highest in three years.","CEO states withdrawal does not affect current revenue-generating product portfolio."],"urls":{"canonical":"https://secwatch.observer/filing/0000898432-22-000616","json":"https://secwatch.observer/filing/0000898432-22-000616.json","markdown":"https://secwatch.observer/filing/0000898432-22-000616.md","text":"https://secwatch.observer/filing/0000898432-22-000616.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/0000898432-22-000616-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1325618/000089843222000616/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T04:17:51.823936+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"}