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

Spectral AI announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its DeepView System, authorizing the company to commence commercial distribution activities in the United States.

The DeepView System is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary artificial intelligence algorithm to assess the healing potential of areas within burn wounds. It provides clinicians with an immediate, data-driven assessment of whether areas within burn wounds are unlikely to heal within 21 days and may require significant medical intervention, enabling earlier and more informed treatment decisions. The image acquisition takes 0.2 seconds, with all image processing and AI model classification taking approximately 20 to 25 seconds. The system is trained and tested against a proprietary clinically validated database of over 340 billion pixels of burn wound image data.

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