Spectral AI Announces Submission to FDA of its DeepView® System

DALLAS, June 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and artificial intelligence (“AI”) algorithms to predict burn healing potential, today announced the submission of its De Novo 510k marketing clearance application to the FDA for the DeepView System, 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 this technology, which does not have a predicate device currently available in the U.S. market. 

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