Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication

Spectral AI, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted De Novo Classification for its DeepView® System. This classification authorizes the company to begin commercial distribution of the system in the United States. The DeepView System is designed for burn care in various medical settings. It is a non-invasive, predictive device that uses multispectral imaging and an AI algorithm to assess the healing potential of burn wounds, identifying areas unlikely to heal within 21 days. The system provides rapid, data-driven assessments to aid clinicians in making informed treatment decisions. This clearance marks a significant milestone for Spectral AI, positioning them to commercialize their innovative technology in wound care.