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

Spectral AI, Inc.

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.

Key facts

Extracted from this filing and checked against the source text.

Shareholder Votes SEC 8-K Item 5.07 confidence 0.9

Spectral AI, Inc. shareholders approved To authorize, for purposes of Nasdaq Marketplace Rule 5635(d), the reservation and issuance of shares of common stock of the Company for sale to Hudson Bay Master Fund Ltd. at the 2026-05-29 meeting.

Outcome: passed
Meeting: 2026-05-29

Exact text from the filing

The stockholders voted at the Annual Meeting to approve the Hudson Bay Proposal.

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Shareholder Votes SEC 8-K Item 5.07 confidence 0.9

Spectral AI, Inc. shareholders approved Election of Directors at the 2026-05-29 meeting.

Proposal: director election
Outcome: passed
Meeting: 2026-05-29

Exact text from the filing

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.

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Shareholder Votes SEC 8-K Item 5.07 confidence 0.9

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.

Proposal: auditor ratification
Outcome: passed
Meeting: 2026-05-29

Exact text from the filing

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.

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Spectral AI, Inc. filing history →

Source: SEC EDGAR

accession 0001213900-26-063486

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