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Spectral AI Says FDA Grants De Novo Classification For Its DeepView System
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Spectral AI, Inc. (NASDAQ:MDAI) ("Spectral AI" or the "Company"), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the U.S. Food and Drug Administration (FDA) granted De Novo Classification for its DeepView® System. With this classification, Spectral AI is authorized to commence commercial distribution activities in the United States. The DeepView System is intended for use in burn care in various settings, including burn centers, trauma centers, and emergency departments.

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