{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-061008","form_type":"8-K","ticker":"MDAI","cik":"0001833498","company_name":"Spectral AI, Inc.","filed_at":"2026-05-26T20:00:52+00:00","discovered_at":"2026-05-26T20:02:00.513275+00:00","generated_at":"2026-05-26T20:04:22.876670+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"confidence":"high","headline":"Spectral AI receives FDA De Novo clearance for DeepView System for burn indication","bullets":["FDA granted De Novo Classification for DeepView System, authorizing commercial distribution in the US.","DeepView is a non-invasive, multispectral imaging device with proprietary AI algorithm to assess burn wound healing.","System provides clinical assessment in ~20-25 seconds, trained on over 340 billion pixels of burn wound image data.","CEO Vincent Capone calls it a 'defining moment' and 'watershed moment' in the company's history.","Development supported in part by BARDA federal contract 75A50123C00049."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-061008","json":"https://secwatch.observer/filing/0001213900-26-061008.json","markdown":"https://secwatch.observer/filing/0001213900-26-061008.md","text":"https://secwatch.observer/filing/0001213900-26-061008.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1833498/000121390026061008/0001213900-26-061008-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1833498/000121390026061008/ea0292182-8k_spectral.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T20:04:22.876670+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"}