Spectral AI Submits Application To FDA Regarding Its DeepView System

(RTTNews) - Spectral AI, Inc. (MDAI), Monday announced the submission of De Novo 510k marketing clearance application to the U.S. Food and Drug Administration for the DeepView System.

The 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 system is expected to help clinicians with an immediate, data-driven assessment tool designed to assist clinical decision-making and may significantly improve patient outcomes.

In the pre-market hours, Spectral's stock is trading at $2.18, up 2.8 percent on the Nasdaq.