USFDAJun 12, 2026, 08:31 AM
Spectral AI Highlights FDA-Cleared DeepView System for Wound Care
AI Summary
Spectral AI, Inc. is participating in the 10th Annual Wound Healing Awareness Month with the American Board of Wound Management (ABWM) Foundation. The company is highlighting its AI-driven DeepView System for burn indication, which received FDA De Novo Classification in May 2026. This non-invasive, predictive medical device provides rapid, objective assessment of burn wound healing potential, aiming to support more informed treatment decisions and improve patient outcomes. The system delivers a data-driven assessment within 20-25 seconds.
Key Highlights
- DeepView System for burn indication received FDA De Novo Classification in May 2026.
- The system assesses burn wound healing potential, identifying areas unlikely to heal within 21 days.
- Image acquisition takes 0.2 seconds, with processing and AI classification taking 20-25 seconds.
- The DeepView System is trained and tested against over 340 billion pixels of burn wound image data.
- Spectral AI is joining the ABWM Foundation in celebrating the 10th Annual Wound Healing Awareness Month.
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