Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication
Spectral AI received FDA De Novo classification for its DeepView System, authorizing immediate commercial distribution in the United States for burn care diagnostics. The AI-driven device provides clinicians with a predictive assessment of burn wound healing potential within 25 seconds, aiming to redefine the standard of care by enabling earlier interventions.
Key figures
- Drug Name
- DeepView System
- Phase Of Trial
- De Novo
- Processing time
- 20 to 25 seconds
- Training data pixels
- 340 billion
- Image acquisition time
- 0.2 seconds
AI analysis
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