{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-000035","form_type":"8-K","ticker":"DXR","cik":"0000027367","company_name":"DAXOR CORP","filed_at":"2024-01-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:26.513289+00:00","generated_at":"2026-06-07T05:37:19.273601+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Daxor submits next-gen BVA to FDA for 510(k)/CLIA-waiver; clearance expected H1 2024","bullets":["Submission via dual 510(k)/CLIA-waiver pathway to FDA for next-generation blood volume analyzer.","New device designed to be three times faster, simpler, portable, and capable of bedside analysis.","Development funded under contract by U.S. Department of Defense.","Potential FDA clearance is expected during the first half of 2024.","Current BVA-100 is only FDA-cleared diagnostic for direct blood volume measurement."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-000035","json":"https://secwatch.observer/filing/0001493152-24-000035.json","markdown":"https://secwatch.observer/filing/0001493152-24-000035.md","text":"https://secwatch.observer/filing/0001493152-24-000035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/27367/000149315224000035/0001493152-24-000035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/27367/000149315224000035/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T05:37:19.273601+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"}