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

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.