Spectral AI submits De Novo request to FDA for DeepView burn assessment system

Spectral AI, Inc.

Spectral AI submitted a De Novo request to the FDA for its DeepView System on June 30, 2025.
DeepView System uses multispectral imaging and AI to assess burn wound healing potential within 7 days of injury.
Due to novel technology with no predicate device, the De Novo regulatory pathway is being pursued.
System trained on over 340 billion clinically validated data points to provide non-healing prediction.
DeepView received Breakthrough Device Designation from FDA in 2018.

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