{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-106999","form_type":"8-K","ticker":"BJDX","cik":"0001704287","company_name":"Bluejay Diagnostics, Inc.","filed_at":"2026-10-06T13:04:23+00:00","discovered_at":"2026-10-06T13:05:00.241041+00:00","generated_at":"2026-10-12T16:30:32.710674+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Bluejay Diagnostics SYMON-II study has 777 patients, 18% 28-day mortality; supports IL-6 510(k) path","bullets":["Preliminary SYMON-II analysis includes 777 evaluable patients: 637 28-day survivors and 140 non-survivors, an overall 28-day mortality rate of about 18%.","39.5% of the study population met Sepsis-3 criteria for septic shock; septic shock present in 56.4% of non-survivors vs 35.8% of survivors.","84.0% of patients had bacterial infection, 32.4% had a positive blood culture, and infection was highly likely or likely in 86.5%.","SYMON-II is the pivotal study intended to support a 510(k) application to FDA for the Symphony IL-6 Test; the test is not cleared or approved and not commercially available in the U.S.","Bluejay continues analyzing IL-6 measurements versus 28-day mortality; baseline characteristics alone do not establish prognostic performance, clinical utility, sensitivity or specificity."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-106999","json":"https://secwatch.observer/filing/0001213900-26-106999.json","markdown":"https://secwatch.observer/filing/0001213900-26-106999.md","text":"https://secwatch.observer/filing/0001213900-26-106999.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/0001213900-26-106999-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1704287/000121390026106999/ea0307769-8k_bluejay.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T16:30:32.710674+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"}