DALLAS, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the completion of enhancements to its technical file to support significant software updates for its DeepView SnapShot® M and DeepView AI-Burn® system in the UK. These upgrades, informed by real-world experience and frontline feedback from clinicians, are designed to enhance product performance and usability in the UK, further solidifying the Company's commitment to delivering and commercializing cutting-edge solutions in critical care settings.

This regulatory milestone ensures Spectral AI can implement the updated software on its DeepView SnapShot® M and AI-Burn® systems currently deployed in the UK, where the devices are authorized as two separate products. The enhanced software reflects invaluable input from frontline users, enabling improvements in diagnostic accuracy, workflow integration, and patient care. These updates represent Spectral AI's dedication to incorporating direct clinician feedback into its technology, ensuring it meets the demands of real-world healthcare environments.

The formal enhancement to the technical file also assists Australian burn centers as Spectral AI is operating under the country's unique access program, the Approved Prescriber Program. This move ensures that Australian healthcare providers will be provided with access to Spectral AI's most advanced diagnostic technology.

Dr. J. Michael DiMaio, Chairman of the Board at Spectral AI, said, “The regulatory status of our products in the UK is essential, as both hospital ethics committees and the Therapeutic Goods Administration (TGA) in Australia rely on UK authorization and technical file documentation to support the use of our devices. These upgrades reflect our commitment to continuous improvement, ensuring our technologies deliver optimal outcomes for clinicians and patients alike. As we get additional feedback from real-world usage, we will continue to improve DeepView’s performance and impact on patient care. The feedback from the UK has been extremely encouraging and affirms my belief that DeepView can contribute significantly to enhanced patient care in the UK and other countries.”

With these enhancements, Spectral AI continues to lead the way in AI-driven wound diagnostics, integrating real-world insights to meet clinicians' complex needs and improve patient outcomes.

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 and diabetic foot ulcers. The Company is working to revolutionize wound care management by "Seeing the Unknown®" with its DeepView® System. DeepView is a predictive device that offers clinicians 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 of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight toward value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, 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 intention to separate its Spectral IP subsidiary from the Company, and each Company’s strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. 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 SEC, including the 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. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.

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