Spectral AI Receives FDA De Novo Clearance for DeepView® System for Burn Indication

DALLAS, May 26, 2026 — Spectral AI, a medical diagnostics company specializing in AI-driven wound care solutions, announced that the U.S. Food and Drug Administration (FDA) granted De Novo classification to its DeepView System. This approval allows the company to begin commercial distribution in the U.S., enabling its use in burn centers, trauma centers, and emergency departments for burn wound assessment. The DeepView System utilizes multispectral imaging paired with a proprietary AI algorithm to evaluate a burn wound’s healing potential within 20 to 25 seconds. It provides clinicians with immediate data-driven insights, identifying areas unlikely to heal within 21 days and requiring intervention. The system’s image acquisition takes just 0.2 seconds, and its analysis is backed by a database of over 340 billion pixels of clinically validated burn wound images. The technology aims to improve patient outcomes by enabling earlier, more informed treatment decisions while aligning care quality with cost efficiency. Spectral AI’s Chief Executive Officer, Vincent Capone, described the FDA clearance as a milestone validating the company’s vision of revolutionizing burn care diagnostics. Development of the DeepView System has been supported in part by federal funds from the Department of Health and Human Services (DHHS) through the Biomedical Advanced Research and Development Authority (BARDA). The project’s findings are not formally endorsed by DHHS but reflect collaborative efforts to advance predictive medical technology. Based in Dallas, Spectral AI focuses on AI-driven diagnostics for wound care, with its DeepView System designed to offer objective, algorithm-based assessments before treatment. The company has been recognized as one of TIME’s World’s Top HealthTech companies in 2025. Further details are available on its official website.