Spectral AI shares rise 5.65% premarket after FDA submission for DeepView System.

Spectral AI, Inc. rose 5.65% in premarket trading, with the company announcing the submission of its De Novo 510k marketing clearance application to the FDA for the DeepView System, intended for use in burn care settings. The DeepView System is a non-invasive, predictive medical device that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of burn wounds. Additionally, the company appointed Stanley Micek as its Chief Operating Officer, who has been leading the teams for data science, software, hardware, imaging, and systems directly involved in the FDA submission.