MDAI Spectral Ai, Inc. - 8-K

Item
7.01. Regulation FD Disclosure.

On
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).

1