FDA Grants De Novo OK to Spectral AI’s DeepView System

Spectral AI, an artificial intelligence (AI) company targeting diagnostics for wound care, has been awarded U.S. Food and Drug Administration (FDA) de novo classification for its DeepView system.

The DeepView system is meant for use in burn care in various settings like burn centers, trauma centers, and emergency departments. With the de novo classification, the company can begin commercial distribution activities in the U.S.

Spectral AI’s system is a non-invasive, predictive device that combines multispectral imaging with a proprietary AI algorithm to evaluate the healing potential of areas in the burn wounds. It provides an immediate, data-driven assessment of whether areas in burn wounds are unlikely to heal within 21 days and may need significant medical intervention.

“We are pleased that the FDA has recognized our novel technology,” said Spectral AI’s CEO Vincent Capone. “I am grateful for our dedicated team of employees and this milestone represents the culmination of years of hard work. 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 that provides a Day One diagnostic assessment of a burn wound’s healing potential.”

Image acquisition takes 0.2 seconds according to the company, with all image processing and AI model classification taking about 20-25 seconds. The DeepView system was trained and tested against a clinically validated database of more than 340 billion pixels of burn wound image data.

“Today we celebrate a watershed moment in the history of Spectral AI,” said Dr. J. Michael DiMaio, chairman of the board of Spectral AI. “Adhering to a mantra of Finance, Focus, and Finish, we are now positioned to commence commercialization of the DeepView System, which we believe has the potential to redefine the standard of care in the assessment and treatment of burn wounds. We are confident that this pioneering technology will provide value across the healthcare ecosystem by improving patient outcomes and aligning care quality with cost efficiency.”