Spectral AI, Inc. 8-K

What Happened
Spectral AI, Inc. (ticker: MDAI) announced on May 26, 2026 (via an 8-K and press release) 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 of DeepView in the United States. The press release was furnished as Exhibit 99.1 to the Current Report on Form 8-K (Item 7.01 Regulation FD Disclosure).

Key Details

• FDA granted De Novo classification for the DeepView® System on May 26, 2026.
• The De Novo decision authorizes Spectral AI to begin commercial distribution in the U.S.
• Announcement furnished to the SEC as a press release (Exhibit 99.1) in the 8-K filing.

Why It Matters
This is a material regulatory milestone: De Novo classification removes a U.S. regulatory barrier and allows Spectral AI to start commercial activities for DeepView in the largest healthcare market. For investors, the decision clears the way for potential sales, commercialization agreements, and subsequent revenue opportunities tied to the product; the 8-K does not include financial results or sales figures.