Spectral AI Inc. (NASDAQ: MDAI) announced the U.S. Food and Drug Administration granted De Novo Classification for its DeepView System, authorizing the company to begin commercial distribution in the United States. The device is intended for use in burn care across burn centers, trauma centers, and emergency departments.

The DeepView System combines multispectral imaging with artificial intelligence algorithms to assess burn wound healing potential. The device provides clinicians with data-driven assessments of whether areas within burn wounds are unlikely to heal within 21 days and may require medical intervention. Image acquisition takes 0.2 seconds, with processing and AI classification requiring approximately 20 to 25 seconds.

"We are pleased that the FDA has recognized our novel technology," said Vincent Capone, Chief Executive Officer. "Our ability to obtain FDA De Novo classification is a defining moment in Spectral AI's history and a validation of our shared vision to bring to market our innovative predictive medical technology."

The system operates as a non-invasive predictive medical device that enables earlier treatment decisions. The technology was trained and tested against a database containing over 340 billion pixels of burn wound image data, according to the company.

The development received support from the Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50123C00049. The Dallas-based company focuses on medical diagnostics for wound care treatment decisions.

Dr. J. Michael DiMaio, Chairman of the Board, stated the FDA clearance positions the company to commence commercialization of the device, which the company believes could impact burn wound assessment and treatment standards.