---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-061008"
form_type: "8-K"
ticker: "MDAI"
cik: "0001833498"
company_name: "Spectral AI, Inc."
filed_at: "2026-05-26T20:00:52+00:00"
generated_at: "2026-05-26T20:04:22.876670+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Spectral AI receives FDA De Novo clearance for DeepView System for burn indication

## Summary
- FDA granted De Novo Classification for DeepView System, authorizing commercial distribution in the US.
- DeepView is a non-invasive, multispectral imaging device with proprietary AI algorithm to assess burn wound healing.
- System provides clinical assessment in ~20-25 seconds, trained on over 340 billion pixels of burn wound image data.
- CEO Vincent Capone calls it a 'defining moment' and 'watershed moment' in the company's history.
- Development supported in part by BARDA federal contract 75A50123C00049.

## SEC filing metadata
- accession: 0001213900-26-061008
- form_type: 8-K
- ticker: MDAI
- cik: 0001833498
- company_name: Spectral AI, Inc.
- filed_at: 2026-05-26T20:00:52+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1833498/000121390026061008/0001213900-26-061008-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1833498/000121390026061008/ea0292182-8k_spectral.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-061008
- JSON: https://secwatch.observer/filing/0001213900-26-061008.json
- Plain text: https://secwatch.observer/filing/0001213900-26-061008.txt

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