---
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"
generated_at: "2026-05-18T14:36:44.302853+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Spectral AI submits De Novo request to FDA for DeepView burn assessment system

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-059623
- JSON: https://secwatch.observer/filing/0001213900-25-059623.json
- Plain text: https://secwatch.observer/filing/0001213900-25-059623.txt

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