Spectral AI receives FDA De Novo clearance for DeepView System for burn indication

Spectral AI, Inc.

FDA granted De Novo Classification for DeepView System, authorizing commercial distribution in the US.
DeepView is a non-invasive, multispectral imaging device with proprietary AI algorithm to assess burn wound healing.
System provides clinical assessment in ~20-25 seconds, trained on over 340 billion pixels of burn wound image data.
CEO Vincent Capone calls it a 'defining moment' and 'watershed moment' in the company's history.
Development supported in part by BARDA federal contract 75A50123C00049.

item 7.01 item 9.01

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