DALLAS, June 30, 2025 - Spectral AI $(MDAI)$, a leader in AI-driven medical diagnostics, announced the submission of its De Novo 510k marketing clearance application to the U.S. Food and Drug Administration (FDA) for its innovative DeepView® System. This submission marks a significant milestone for Spectral AI as it seeks to bring its novel burn care diagnostic device to the U.S. market. The DeepView System, which received Breakthrough Device Designation from the FDA in 2018, leverages multi-spectral imaging and AI algorithms to assess burn healing potential, providing clinicians with immediate, data-driven insights to enhance patient care. The development and regulatory efforts for this technology have been supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA under multiple contracts with Spectral MD, Inc., a wholly-owned subsidiary of Spectral AI.
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