{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-059623","form_type":"8-K","ticker":"MDAI","cik":"0001833498","company_name":"Spectral AI, Inc.","filed_at":"2025-06-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.023251+00:00","generated_at":"2026-05-18T14:36:44.302853+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Spectral AI submits De Novo request to FDA for DeepView burn assessment system","bullets":["Spectral AI submitted a De Novo request to the FDA for its DeepView System on June 30, 2025.","DeepView System uses multispectral imaging and AI to assess burn wound healing potential within 7 days of injury.","Due to novel technology with no predicate device, the De Novo regulatory pathway is being pursued.","System trained on over 340 billion clinically validated data points to provide non-healing prediction.","DeepView received Breakthrough Device Designation from FDA in 2018."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-059623","json":"https://secwatch.observer/filing/0001213900-25-059623.json","markdown":"https://secwatch.observer/filing/0001213900-25-059623.md","text":"https://secwatch.observer/filing/0001213900-25-059623.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1833498/000121390025059623/0001213900-25-059623-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1833498/000121390025059623/ea0247532-8k_spectral.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T14:36:44.302853+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"}