Spectral AI announced on June 30, 2025, the submission of its De Novo 510k marketing clearance application to the FDA for the DeepView System, marking a significant regulatory milestone for the AI-driven burn assessment technology. The Dallas-based company is pursuing the De Novo pathway due to the novel nature of this technology, which does not have a predicate device currently available in the U.S. market.
Revolutionary Burn Assessment Technology
The DeepView System represents a breakthrough in burn care diagnostics, combining multispectral imaging with proprietary artificial intelligence algorithms to assess the healing potential of burn wounds. This non-invasive, predictive medical device and associated software platform provides clinicians with non-healing predictions on the same day of injury and up to seven days post-injury, enabling earlier and more informed treatment decisions.
The system is intended for use in burn care settings, including both burn centers and emergency departments, addressing a critical need for objective assessment tools in wound care management.
Clinical Significance and Leadership Perspective
"This FDA submission is a major milestone for Spectral AI and the DeepView System, representing a crucial step toward bringing this innovative diagnostic device to market in the United States," stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. "It provides clinicians with an immediate, data-driven assessment tool designed to assist clinical decision-making and may significantly improve patient outcomes."
DiMaio expressed gratitude to shareholders for their continued support and confidence in the company's mission to bring this technology to the broader healthcare market worldwide.
Government Support and Development History
The DeepView System's development has been substantially supported by federal funding from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA. The current project operates under contract number 75A50123C00049 with Spectral AI's wholly-owned subsidiary Spectral MD, Inc.
Since 2013, the technology's advancement has been supported through multiple contract awards, including previous contracts numbered 75A50119C00033 and HHSO100201300022C, demonstrating sustained government investment in this innovative diagnostic approach.
Breakthrough Device Recognition
The DeepView System received FDA Breakthrough Device Designation in 2018, recognizing its potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This designation facilitates expedited communication with the FDA during the development and review process.
Company Vision and Market Impact
Spectral AI positions itself as a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving burn patients. The company aims to revolutionize wound care management through its "Seeing the Unknown" approach with the DeepView System.
The device is being developed to offer clinicians an objective and immediate assessment of burn wound healing potential prior to treatment or other medical intervention. With algorithm-driven results, the DeepView System is expected to provide fast and accurate treatment insights toward value-based care by improving patient outcomes and reducing healthcare costs.
