Spectral AI submits De Novo 510K marketing clearance application for DeepView

Spectral AI (MDAI) announced the submission of its De Novo 510k marketing clearance application to the FDA for the DeepView System, intended for use in burn care settings, including both burn centers and emergency departments. The De Novo regulatory pathway is being pursued due to the novel nature of this technology, which does not have a predicate device currently available in the U.S. market. Spectral AI’s DeepView System is a non-invasive, predictive medical device and associated software platform that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of burn wounds. The DeepView System provides clinicians with a non-healing prediction-on the same day of injury and up to a week post injury, enabling earlier and more informed treatment decisions.