secwatch.observer — SEC 8-K summary
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Issuer:     Spectral AI, Inc. (MDAI)
CIK:        0001833498
Form:       8-K
Filed at:   2024-02-05T23:59:59+00:00
Accession:  0001213900-24-009894
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Spectral AI updates on regulatory progress; expects UK DeepView revenue in H2 2024
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- Submitted DeepView AI-Burn for UKCA marking; response expected 1H 2024; first UK revenue in H2 2024.
- BARDA awarded $149M contract in Sept 2023, total BARDA awards over $250M; $55M for development through Q1 2026.
- Initiated pivotal US burn study with 240 subjects; FDA submission for burn indication expected 1H 2025.
- DFU validation study continues; FDA application for DFU indication anticipated in late 2024.
- Closed $10M Committed Equity Facility with B. Riley; appointed Pete Carlson as CFO.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1833498/000121390024009894/0001213900-24-009894-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1833498/000121390024009894/ea192822-8k_spectralai.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-009894

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer