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Spectral AI Inc. reported $19.6M in revenue and a $7.6M net loss for fiscal 2025. See the full MDAI financial statements: income statement, balance sheet, cash flow and ratios, each column linked to its SEC filing.

Spectral AI to Present at H.C. Wainwright 28th Annual Global Investment Conference

Spectral AI (Nasdaq: MDAI) will present at the H.C.

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Spectral AI (Nasdaq: MDAI) will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York City from September 14–16, 2026. CEO Vincent Capone and CFO David McGuire plan to highlight the company’s growth strategy and readiness for a 2026 commercial launch of its FDA De Novo–cleared DeepView® System for Burn Indication, which received clearance in May 2026. The presentation is scheduled for Monday, September 14, 2026 at 4:00 pm ET, with a live webcast available via the Investors section of Spectral AI’s website, and options to request one-on-one meetings through H.C. Wainwright or the company’s investor relations firm.

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Positive

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Negative

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News Market Reaction – MDAI

-0.96%
-0.96% Session close to close

In the Sep 1 session, MDAI declined 0.96%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The AI-tagged historical set averaged -2.92% over 24 hours, adding a cautious comparison to this con...
Analysis

The AI-tagged historical set averaged -2.92% over 24 hours, adding a cautious comparison to this conference announcement. The active S-3 is a resale registration, and low short positioning was a relevant volatility risk to monitor.

Key Figures

FDA De Novo Clearance: May 2026 First Commercial Sales: Year end 2026 Conference Dates: September 14−16, 2026 +5 more
8 metrics
FDA De Novo Clearance May 2026 DeepView System for burn indication
First Commercial Sales Year end 2026 Company stated it remained on track
Conference Dates September 14−16, 2026 H.C. Wainwright 28th Annual Global Investment Conference
Presentation Time 4:00 pm Eastern Time September 14, 2026 presentation
Healing Assessment Window 21 days Burn-wound areas unlikely to heal without intervention
Image Acquisition 0.2 seconds DeepView System
Processing and Classification 20 to 25 seconds DeepView System
Burn-Wound Image Data Over 340 billion pixels Proprietary clinically validated database

Previous AI Reports

5 past events · Latest: Jul 08 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 08 Commercial leadership appointment Positive -0.6% Named Darcy Bajko chief commercial officer to lead DeepView commercialization.
Jun 12 Wound-care partnership Positive -2.1% Partnered with wound-management foundation during Wound Healing Awareness Month.
Jun 11 Conference participation Positive +1.6% Presented DeepView at the British Burn Association annual conference.
Jun 01 Annual meeting results Positive -1.9% Stockholders approved proposals including share reservations under the purchase agreement.
May 26 FDA clearance Positive -11.6% Received FDA De Novo Classification authorizing U.S. commercial distribution.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

AI-tagged events averaged a -2.92% 24-hour price reaction, with four divergences and one alignment.

Key Terms

de novo clearance, multispectral imaging
2 terms
de novo clearance regulatory
"receipt of FDA De Novo Clearance for our DeepView® System"
A regulatory pathway used by the U.S. Food and Drug Administration to grant marketing authorization to novel medical devices that have no legally marketed predicate and are considered low-to-moderate risk. It creates a new device classification and allows the product to be sold under specified controls; think of it like the FDA creating a new product category and issuing a permit where no comparable item existed. For investors, de novo clearance matters because it determines time-to-market, potential exclusivity in a new category, and the competitive landscape for companies developing novel devices.
multispectral imaging technical
"combines multispectral imaging with a proprietary AI algorithm"
Multispectral imaging is a way of taking pictures that capture light across several distinct bands, including wavelengths the human eye cannot see, to reveal material properties or features hidden in ordinary photos. For investors, this technology can signal improved product capabilities, more accurate testing or monitoring, and new market opportunities or cost savings for companies that use it, making it a factor in competitive advantage and capital allocation decisions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Company to Highlight Growth Strategy and Readiness for 2026 Commercial Launch of  FDA-Cleared DeepView® System for Burn Indication

DALLAS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that Vincent Capone, Chief Executive Officer, and David McGuire, Chief Financial Officer, are scheduled to present at the H.C. Wainwright 28th Annual Global Investment Conference, taking place September 14−16, 2026 in New York City.

“The receipt of FDA De Novo Clearance for our DeepView® System for Burn Indication in May 2026 was the culmination of years of hard work by our dedicated team and a defining moment in Spectral AI’s history,” said Vincent Capone, Chief Executive Officer. “We have made significant strides in evolving our company into a commercially focused enterprise, including expanding our leadership team, advancing label expansion initiatives, strengthening our relationships with government and commercial partners, and fortifying our financial position. We remain on track to achieve our first commercial sales by year end 2026.”

Conference Details

  • Presentation Date & Time: Monday, September 14, 2026 at 4:00 pm Eastern Time.
  • Live Webcast: Interested parties may access the live webcast of the presentation by visiting the Investors section of Spectral AI’s website at https://investors.spectral-ai.com/news-events/events.
  • 1x1 Meetings: To request a one-on-one meeting, please contact your H.C. Wainwright representative or Spectral AI’s Investor Relations firm, The Equity Group.
  • Additional Information: Please visit the conference website.

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 burn wounds. The DeepView System provides physicians 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.

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 a predictive diagnostic device that offers physicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to exceed the current standard of care, the DeepView System provides fast and accurate treatment insights to improve patient outcomes and reduce 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,” “on track,” “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 the 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 Annual Report on Form 10-K for the year ended December 31, 2025 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, Managing Director
Devin.Sullivan@theequitygroup.com

Conor Rodriguez, Associate
Conor.Rodriguez@theequitygroup.com


FAQ

What will Spectral AI (Nasdaq: MDAI) present at the H.C. Wainwright 28th Annual Global Investment Conference 2026?

Spectral AI will present its growth strategy and readiness for a 2026 commercial launch of its FDA-cleared DeepView System for burn indication. According to Spectral AI, leadership will discuss commercialization progress, label expansion efforts, partnerships, and the company’s transition toward a commercially focused wound-care diagnostics enterprise.

When is Spectral AI's (MDAI) presentation at the H.C. Wainwright conference and how can investors watch the webcast?

Spectral AI is scheduled to present on Monday, September 14, 2026, at 4:00 pm Eastern Time at the H.C. Wainwright conference. According to Spectral AI, a live webcast will be accessible through the Investors section of its website under the news and events page.

What is Spectral AI's DeepView System for burn indication and how does it work?

DeepView is a non-invasive predictive medical device that assesses healing potential within burn wounds using multispectral imaging and proprietary AI algorithms. According to Spectral AI, it delivers an immediate, data-driven assessment of areas unlikely to heal within 21 days, helping physicians make earlier, more informed treatment and intervention decisions.

Has Spectral AI (MDAI) received FDA clearance for the DeepView System, and when was it granted?

Yes, Spectral AI received FDA De Novo Clearance for its DeepView System for Burn Indication in May 2026. According to Spectral AI, this clearance marked a defining milestone for the company and underpins its planned first commercial sales and broader commercialization activities in late 2026.

When does Spectral AI expect first commercial sales of the DeepView System and what is the 2026 launch timeline?

Spectral AI expects its first commercial sales of the DeepView System by year-end 2026, following FDA De Novo clearance. According to Spectral AI, the company is preparing for a 2026 commercial launch while expanding leadership, advancing label expansion, deepening partnerships, and strengthening its financial position.

How fast does Spectral AI's DeepView System deliver burn wound assessments and what data supports its AI model?

DeepView captures images in about 0.2 seconds and processes them with AI in roughly 20–25 seconds. According to Spectral AI, the system is trained and tested on a clinically validated database containing more than 340 billion pixels of burn wound image data.

How can investors arrange one-on-one meetings with Spectral AI (Nasdaq: MDAI) during the H.C. Wainwright 2026 conference?

Investors can request one-on-one meetings through their H.C. Wainwright representative or via Spectral AI’s investor relations firm, The Equity Group. According to Spectral AI, contact details for key IR representatives are provided, enabling tailored investor discussions during the conference.