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.
For comments and feedback contact: editorial@rttnews.com
Health News
May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.