Spectral AI Submits New Technology Add-On Payment (NTAP) Application for DeepView™ System

If approved, additional hospital payments would generally begin in October 2027 and continue for approximately three years.

Rhea-AI Summary

Spectral AI (MDAI) submitted an application for additional Medicare inpatient payments for its DeepView System through an alternative reimbursement pathway.

The New Technology Add-On Payment (NTAP) program provides extra hospital payments for qualifying cases involving new technologies. DeepView assesses burn-wound healing potential and received FDA De Novo marketing authorization in May 2026. Its Breakthrough Device Designation and FDA authorization enabled the reimbursement application.

Spectral AI expects a CMS decision in August 2027. If approved, payment status would generally begin in October 2027 and continue for approximately three years. Additional payments are generally limited to approximately 65% of the technology's estimated cost and remain subject to CMS requirements. The company said reimbursement could help offset hospitals' incremental costs and reduce adoption barriers.

4 points · 0 major

MixediHow this balance works

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointNTAP application submitted through the alternative pathway, pursuing additional inpatient reimbursement for DeepView.
• Minor pointFDA marketing authorization in May 2026 and Breakthrough Device Designation enabled additional reimbursement opportunities.
• Minor point. Forward-looking: it has not happened yet and may not happen.Reimbursement support could offset hospital costs and reduce adoption barriers, the company said.
• Minor point. Forward-looking: it has not happened yet and may not happen.Other payment and reimbursement pathways remain under evaluation to support the company's commercialization objectives.

Negative

• Moderate point. Forward-looking: it has not happened yet and may not happen.CMS approval remains pending; Spectral AI anticipates a final determination in August 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Additional payments are generally limited to approximately 65% of estimated technology cost, subject to CMS requirements.
• Minor pointCapital spending is being committed to pursuing additional reimbursement pathways.

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Details

Market Reaction – MDAI

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On Oct 6, the day this news came out, the latest delayed price for MDAI is 0.89% above the previous close. Argus tracked a peak move of +2.6% during the session. Our momentum scanner has recorded 7 alerts for this stock so far that day. The latest delayed price is $1.71. Relative volume is very high at 4.7x the average.

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Key Figures

Expected CMS determination: August 2027 Potential payment start: October 2027

Expected CMS determination

August 2027

NTAP application

Potential payment start

October 2027

If approved

Key Terms

ntap, de novo classification, breakthrough device designation, multispectral imaging

4 terms

ntap regulatory

"submission of a New Technology Add-On Payment (NTAP) application"

NTAP is a stock exchange ticker symbol — a short code used to identify a particular company’s publicly traded shares on an exchange. For investors it matters because the ticker is the quick identifier used to look up real-time prices, trade the stock, check ownership and find news or filings; think of it like a vehicle’s license plate that instantly points you to everything specific about that car in traffic.

de novo classification regulatory

"It was granted De Novo Classification by the U.S. Food and Drug Administration"

A de novo classification is a regulatory pathway that lets a novel medical device without an existing equivalent be reviewed and approved as low-to-moderate risk so it can legally enter the market. For investors, it matters because it can unlock a faster, clearer route to sales and competition protection for a new product — like getting a brand-new grocery item its own shelf space rather than forcing it to fit an existing category.

breakthrough device designation regulatory

"The Company’s Breakthrough Device Designation and recent FDA De Novo marketing authorization"

A breakthrough device designation is a regulatory program that gives promising medical devices for serious or life‑threatening conditions priority support and faster review from a health authority (e.g., the U.S. FDA). Think of it as a “fast lane” or VIP pass through development and review: it can shorten time to market, lower regulatory uncertainty, and boost a company’s commercial prospects — but it is not an approval by itself.

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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DALLAS, Oct. 06, 2026 (GLOBE NEWSWIRE) -- 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 the submission of a New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services (CMS) for its DeepView™ System utilizing the alternative pathway.

The NTAP program is designed to provide an additional hospital inpatient payment for eligible procedures involving new technologies or medical services that meet CMS requirements, helping to address the additional costs associated with incorporating innovative technologies into patient care while providing timely access to these advancements.

Spectral AI's DeepView System is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within burn wounds. It was granted De Novo Classification by the U.S. Food and Drug Administration (“FDA”) in May 2026.

“We are investing significant capital in pursuing additional reimbursement pathways as we recognize the importance of supporting hospitals as they incorporate the DeepView System into their clinical workflows and facilitate patient access to care for this innovative technology,” said Vincent Capone, Chief Executive Officer. “An NTAP payment, if approved, would represent a meaningful component of the economic value proposition for hospital systems that adopt the DeepView System. It could help offset a meaningful portion of the incremental cost of incorporating this innovative technology into the patient workflow, while enabling clinicians to access rapid, objective information to support burn-wound assessment and treatment decisions.”

Under the NTAP program, qualifying cases may receive an additional Medicare payment, subject to applicable CMS requirements and payment limitations. Generally, the additional payment is limited to approximately 65% of the estimated cost of the new technology. The Company’s Breakthrough Device Designation and recent FDA De Novo marketing authorization for the DeepView System has enabled us to pursue additional reimbursement opportunities as part of our commercialization process. The Company anticipates a final determination from CMS regarding its application in August 2027. If approved, NTAP payment status would generally be available beginning in October 2027 and continue for approximately three years.

Mr. Capone concluded, “Additional reimbursement support could improve patient access to care and help reduce adoption barriers for eligible health systems, making it easier to integrate and utilize the DeepView System in appropriate inpatient settings. We will continue to evaluate other payment and reimbursement pathways that support our commercialization objectives.”

About the DeepView™ System

Spectral AI's DeepView System is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within burn wounds. It was granted De Novo Classification by the U.S. Food and Drug Administration in May 2026 and received its initial UKCA (UK Conformity Assessed) authorization in the United Kingdom in February 2024. 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. For more information about the DeepView System, visit www.spectral-ai.com.

The Company’s contract with the Biomedical Advanced Research and Development Authority (“BARDA”) is held and performed through its wholly owned subsidiary, Spectral MD. References to the contract, associated awards, related revenue, business opportunities, obligations, and other relevant factors should be understood to refer to Spectral MD as the contracting party unless otherwise indicated.

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 Managing Director Devin.Sullivan@theequitygroup.com	Conor Rodriguez Associate Conor.Rodriguez@theequitygroup.com

FAQ

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What reimbursement application did Spectral AI submit for DeepView?

Spectral AI submitted a New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services through the alternative pathway. The program provides additional hospital inpatient payments for eligible cases involving new technologies that meet CMS requirements.

When could DeepView receive NTAP payment status?

Spectral AI anticipates a CMS determination in August 2027; if approved, NTAP payment status would generally become available in October 2027 and continue for approximately three years. Approval has not yet been granted.