By John Vandermosten, CFA

NASDAQ:MDAI

READ THE FULL MDAI RESEARCH REPORT

Last week, Spectral AI, Inc. (NASDAQ:MDAI) announced the submission of its De Novo 510(k) marketing clearance application to the FDA for the DeepView system in burn diagnosis. The submission includes data generated by the multi-center burn study that diagnosed wounds in diverse clinical settings. The achievement is a major milestone for the company and positions Spectral for acceptance of the application in the near term. After acceptance, the FDA targets a 150-day review process. If the FDA is able to keep to its published timelines, clearance for the DeepView burn diagnostic could arrive by year end.

Upon receiving a De Novo request, the FDA conducts an acceptance review within 15 calendar days to determine if the submission is administratively complete. If accepted, the application proceeds to substantive review. During the substantive review, the agency evaluates whether the device’s safety and effectiveness can be assured through general and special controls. After resolving all deficiencies and completing the review, the FDA will either grant or decline De Novo classification. If granted, a new device classification is established, and the device can serve as a predicate for future 510(k) submissions.^[1]

UK Multi-Center Burn Study

The submission follows results from DeepView’s clinical trial which were published in the Journal Burns. The Journal of the International Society for Burn Injuries is a peer-reviewed medical journal centered on research and advancements in the field of burn care, wound healing and thermal injury treatment. It is a platform for clinicians, surgeons and researchers to share new findings, techniques and best practices in burn management. Results shared in the article highlighted the greater than 95% accuracy of DeepView to predict burn healing. The paper also assessed the sensitivity, specificity, accuracy and predictive value of the DeepView burn diagnostics along with other metrics. Several features of the device represent valuable additions to a burn ward. These include portability, ease of use, easily understandable output and ability to indicate areas of healing and non-healing are a few of the benefits that accrue to providers. The paper concluded that the DeepView device represents a potential solution to burn diagnosis that delivers consistent, reliable and objective results. The device empowers clinicians to diagnose with increased accuracy and to use improved treatment strategies for burn victims.

A link to the Journal article is available here: Artificial Intelligence-Enhanced Multispectral Imaging for Burn Wound Assessment: Insights from a Multi-Centre UK evaluation. We summarize the primary findings from the paper in the exhibit below.

Details from the study were further presented by Leslie Poh Hong Tan of the Royal Victoria Infirmary at the British Burn Association conference under the title Artificial Intelligence-Enhanced Multispectral Imaging for Burn Wound Assessment: Insights from a Multi-Centre UK Trial.

In a separate but related series of interviews, article author Dr. Christopher J. Lewis provides a discussion of DeepView and the results from the UK study. We include links to the excerpts below.

Selections from the podcast series with Dr. Chris Lewis:

• Spectral AI's DeepView Achieves 95% Accuracy
• AI Improves Burn Diagnosis
• Spectral AI's Snapshot M
• DeepView Results Published in Burns
• Journal Article Highlights DeepView Diagnostic
• Chris Lewis Highlights DeepView's Strengths
• Lewis Discusses Unmet Needs in Burn Diagnosis
• Fireside Chat with Burn Surgeon Dr. Chris Lewis

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^{[1] U.S. Food & Drug Administration webpage: De Novo Classification Request. Accessed July 2025.}