10:29 AM EDT, 06/30/2025 (MT Newswires) -- Spectral AI (MDAI) said Monday it submitted its De Novo 510k marketing clearance application to the US Food and Drug Administration for the DeepView System's use in burn care settings, including emergency departments.

Spectral AI's DeepView System leverages spectral imaging and artificial intelligence algorithms to forecast the potential for healing burn wounds, according to a statement.

"This FDA submission is a major milestone for Spectral AI and the DeepView System, representing a crucial step toward bringing this innovative diagnostic device to market in the United States," stated board chairman J. Michael DiMaio.

Shares were up 15% in recent trading.

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