USFDAMay 26, 2026, 04:07 PM
Spectral AI DeepView System Gets FDA De Novo Clearance
AI Summary
Spectral AI, Inc. announced that the U.S. Food and Drug Administration (FDA) granted De Novo Classification for its DeepView System. This classification authorizes the company to commence commercial distribution activities in the United States for its AI-powered medical device. The DeepView System is designed for burn care, providing a rapid, non-invasive assessment of burn wound healing potential to aid in treatment decisions.
Key Highlights
- Spectral AI received FDA De Novo Classification for its DeepView System.
- The classification authorizes commercial distribution activities in the United States.
- DeepView System is intended for use in burn care in burn centers, trauma centers, and emergency departments.
- The system provides a Day One diagnostic assessment of a burn wound's healing potential.
- It's a non-invasive, predictive medical device combining multispectral imaging with a proprietary AI algorithm.
- The system assesses if burn wounds are unlikely to heal within 21 days, enabling earlier treatment decisions.
- Image acquisition takes 0.2 seconds, with processing and AI classification taking 20-25 seconds.
- DeepView System is trained and tested against a database of over 340 billion pixels of burn wound image data.
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