secwatch.observer — SEC 8-K summary
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Issuer:     Spectral AI, Inc. (MDAI)
CIK:        0001833498
Form:       8-K
Filed at:   2025-03-17T23:59:59+00:00
Accession:  0001213900-25-024540
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Spectral AI DeepView System outperforms burn physicians in validation study; FDA submission planned mid-2025
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- DeepView sensitivity 86.6% vs burn physicians 40.8% at image-wise level; pixel-wise 81.9% vs 38.8%.
- Dice score 68.5% vs 39.2%; specificity 61.2% vs anticipated 36% (CJA 79.1%).
- Study enrolled 164 patients (115 adult, 49 pediatric) across U.S. burn centers; one of largest U.S. burn trials.
- Plans FDA De Novo submission by Q2 2025; targets clearance early 2026 and rapid commercialization.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1833498/000121390025024540/0001213900-25-024540-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1833498/000121390025024540/ea0234647-8k_spectral.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-024540

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