Spectral AI, Inc. announced on June 30, 2025, the submission of its De Novo 510k marketing clearance application to the U.S. Food and Drug Administration (FDA) for the DeepView System. This application is intended for use in burn care settings, including both burn centers and emergency departments.
The De Novo regulatory pathway is being pursued due to the novel nature of the DeepView System, as there is no predicate device currently available in the U.S. market. The system is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary AI algorithm to assess burn wound healing potential.
Dr. J. Michael DiMaio, Chairman of the Board, stated that this FDA submission is a major milestone for Spectral AI and the DeepView System. It represents a crucial step toward bringing this innovative diagnostic device to market in the United States, providing clinicians with an immediate, data-driven assessment tool.
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