---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-024540"
form_type: "8-K"
ticker: "MDAI"
cik: "0001833498"
company_name: "Spectral AI, Inc."
filed_at: "2025-03-17T23:59:59+00:00"
generated_at: "2026-05-24T16:31:04.287372+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Spectral AI DeepView System outperforms burn physicians in validation study; FDA submission planned mid-2025

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-024540
- form_type: 8-K
- ticker: MDAI
- cik: 0001833498
- company_name: Spectral AI, Inc.
- filed_at: 2025-03-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1833498/000121390025024540/0001213900-25-024540-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1833498/000121390025024540/ea0234647-8k_spectral.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-024540
- JSON: https://secwatch.observer/filing/0001213900-25-024540.json
- Plain text: https://secwatch.observer/filing/0001213900-25-024540.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.