---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-26-063486"
form_type: "8-K"
ticker: "MDAI"
cik: "0001833498"
company_name: "Spectral AI, Inc."
filed_at: "2026-06-01T20:01:42+00:00"
generated_at: "2026-06-01T20:04:26.317600+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Spectral AI gets FDA clearance for DeepView burn indication; targets first commercial sales by year-end 2026

## Summary
- FDA De Novo clearance for DeepView System for Burn Indication; commercial distribution authorized in US.
- BARDA awarded $31.7M advanced funding to accelerate DeepView System features.
- All five director nominees elected; shareholders approved auditor and Hudson Bay share issuance.
- First commercial sales expected by Q4 2026 in US (up to 30 devices via BARDA) and international markets.
- Outcome Study planned for Q4 2026 with ~286 patients across 12 sites.

## SEC filing metadata
- accession: 0001213900-26-063486
- form_type: 8-K
- ticker: MDAI
- cik: 0001833498
- company_name: Spectral AI, Inc.
- filed_at: 2026-06-01T20:01:42+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 5.07, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/0001213900-26-063486-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/ea0292962-8k_spectral.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-063486
- JSON: https://secwatch.observer/filing/0001213900-26-063486.json
- Plain text: https://secwatch.observer/filing/0001213900-26-063486.txt

## Source-grounded claims
- claim_id: 2952846820c4850b362968ed481987b7bc8f5e06
  claim: Spectral AI, Inc. shareholders approved To authorize, for purposes of Nasdaq Marketplace Rule 5635(d), the reservation and issuance of shares of common stock to Hudson Bay Master Fund Ltd. at the 2026-05-29 meeting.
  evidence_excerpt: The stockholders voted at the Annual Meeting to approve the Hudson Bay Proposal. Votes For Votes Against Abstentions Broker Non-Votes 9,272,055 1,838,069 134,311 6,023,135
  evidence_url: https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/0001213900-26-063486-index.htm
- claim_id: 613f4790090344f1adb2d1e26dfd4397e2db0ed8
  claim: Spectral AI, Inc. shareholders approved Election of Directors at the 2026-05-29 meeting.
  evidence_excerpt: The following individuals, each of whom was nominated for election to the Board of Directors (the “ Board ”) by the Company, were elected by the stockholders at the Annual Meeting for a term of one year expiring at the 2027 Annual Meeting of stockholders. Name Votes For Votes Against Abstentions Broker Non-Votes J. Michael DiMaio 10,157,155 - 1,087,280 6,023,135 Richard Cotton 10,020,873 - 1,223,562 6,023,135 Martin Mellish 10,916,549 - 327,886 6,023,135 Deepak Sadagopan 11,061,892 - 182,543 6,023,135 Marion Snyder 10,916,357 - 328,078 6,023,135
  evidence_url: https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/0001213900-26-063486-index.htm
- claim_id: a865b8283f501ac8cf12895db38cd573840f11fa
  claim: Spectral AI, Inc. shareholders approved (Advisory) Non-Binding ratification of the appointment of the Company’s independent registered public accounting firm at the 2026-05-29 meeting.
  evidence_excerpt: The stockholders voted at the Annual Meeting to ratify the appointment of Forvis Mazars LLP as the Company’s independent registered public accounting firm for fiscal year 2026. Votes For Votes Against Abstentions Broker Non-Votes 16,980,334 15,679 271,557 -
  evidence_url: https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/0001213900-26-063486-index.htm

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