Form 8-K

8-K — Spectral AI, Inc.

Accession: 0001213900-26-061008

Filed: 2026-05-26

Period: 2026-05-26

CIK: 0001833498

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0292182-8k_spectral.htm (Primary)

EX-99.1 — PRESS RELEASE ISSUED BY SPECTRAL AI, INC. ON MAY 26, 2026 (ea029218201ex99-1.htm)

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8-K — CURRENT REPORT

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

PURSUANT

TO SECTION 13 OR 15(D) OF THE

SECURITIES

EXCHANGE ACT OF 1934

Date

of Report (Date of earliest event reported): May 26, 2026

SPECTRAL

AI, INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-40058

85-3987148

(State

or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification No.)

2515

McKinney Avenue, Suite 1000

Dallas,

Texas

75201

(Address

of principal executive offices)

(Zip

Code)

(972)

499-4934

(Registrant’s

telephone number, including area code)

Not

Applicable

(Former

name or former address, if changed since last report)

Check

the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of

the following provisions:

☐

Written communication pursuant

to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant

to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications

pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencements communications

pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbols

Name

of each exchange on

which registered

Common

Stock, par value $0.0001 per share

MDAI

The

Nasdaq Stock Market LLC

Redeemable

Warrants, each whole warrant exercisable for one share of Common Stock, at an exercise price of $2.75 per share

MDAIW

The

Nasdaq Stock Market LLC

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☒

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

7.01. Regulation FD Disclosure.

May 26, 2026, the Company issued a press release announcing that the U.S. Food and Drug Administration granted De Novo Classification

for its DeepView® System. With this classification, the Company is authorized to commence commercial distribution activities in the

United States. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The

information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 furnished herewith, shall not be deemed

to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),

or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing

under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such

a filing.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press Release issued by Spectral AI, Inc. on May 26, 2026.

104

Cover Page Interactive

Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Dated:

May 26, 2026

SPECTRAL AI, INC.

By:

/s/

Vincent S. Capone

Name:

Vincent S. Capone

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE ISSUED BY SPECTRAL AI, INC. ON MAY 26, 2026

EX-99.1

Filename: ea029218201ex99-1.htm · Sequence: 2

Exhibit 99.1

Spectral

AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication

DALLAS,

TX - May 26, 2026 - Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence

(AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the

U.S. Food and Drug Administration (FDA) granted De Novo Classification for its DeepView® System. With this classification, Spectral

AI is authorized to commence commercial distribution activities in the United States. The DeepView System is intended for use in burn

care in various settings, including burn centers, trauma centers, and emergency departments.

“We

are pleased that the FDA has recognized our novel technology. I am grateful for our dedicated team of employees and this milestone represents

the culmination of years of hard work. Our ability to obtain FDA De Novo classification is a defining moment in Spectral AI’s

history and a validation of our shared vision to bring to market our innovative predictive medical technology that provides a Day

One diagnostic assessment of a burn wound’s healing potential,” said Vincent Capone, Chief Executive Officer.

“Today

we celebrate a watershed moment in the history of Spectral AI,” said Dr. J. Michael DiMaio, Chairman of the Board of Spectral AI.

“Adhering to a mantra of Finance, Focus, and Finish, we are now positioned to commence commercialization of

the DeepView System, which we believe has the potential to redefine the standard of care in the assessment and treatment of burn wounds.

We are confident that this pioneering technology will provide value across the healthcare ecosystem by improving patient outcomes and

aligning care quality with cost efficiency.”

About

the DeepView System

Spectral

AI’s DeepView System is a non-invasive, predictive medical device which combines multispectral imaging with a proprietary AI algorithm

to assess the healing potential of areas within the burn wounds. The DeepView System provides clinicians with an immediate, data-driven

assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention,

enabling earlier and more informed treatment decisions. The image acquisition takes 0.2 seconds, and all image processing

and AI model classification takes approximately 20 to 25 seconds. The DeepView System is trained and tested against a proprietary and

clinically validated database of over 340 billion pixels of burn wound image data.

DeepView® System

Source: Spectral AI

Source: Wikimedia

Commons

About

BARDA and its Support of the DeepView System

This

project is being supported in whole or in part with federal funds from the Department of Health and Human Services (DHHS); Administration

for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number

75A50123C00049. The findings and conclusions have not been formally disseminated by the DHHS and should not be construed to represent

any agency determination or policy.

About

Spectral AI

Spectral

AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound

care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by

“Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive diagnostic device

to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical

intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is

expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.

Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView

System, visit www.spectral-ai.com.

Forward-Looking

Statements

Certain

statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions

of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans,

objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,”

“expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,”

“seeks,” “may,” “will,” “should,” “future,” “propose” and variations

of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking

statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of

known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that

could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers

are cautioned not to place undue reliance on any forward-looking statements.

Investors

should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections

of the Company’s filings with the US Securities and Exchange Commission, including the Company’s Registration Statement and

the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause

actual events and results to differ materially from those contained in the forward-looking statements.

Investors:

The Equity Group

Devin Sullivan

Conor Rodriguez

Managing Director

Associate

dsullivan@theequitygroup.com

crodriguez@theequitygroup.com

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