Spectral AI receives FDA clearance for burn wound assessment system
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Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication
May 26, 2026 7:00 AM EDTDALLAS, May 26, 2026 (GLOBE NEWSWIRE) -- 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... More
