Workflow
Spectral AI Announces Submission to FDA of its DeepView® System

Core Viewpoint - Spectral AI has submitted a De Novo 510k marketing clearance application to the FDA for its AI-driven DeepView® System, aimed at improving burn care through predictive assessments of healing potential [1][3]. Company Overview - Spectral AI, based in Dallas, focuses on predictive AI technology for medical diagnostics, particularly in wound care, with an emphasis on burn treatment [4]. - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide non-invasive assessments of burn wounds, enabling timely and informed treatment decisions [2][4]. Product Details - The DeepView System is designed to predict the healing potential of burn wounds on the same day of injury and up to seven days post-injury, which can significantly enhance clinical decision-making [2][3]. - The technology is unique in the U.S. market, as there are currently no predicate devices available, necessitating the De Novo regulatory pathway for approval [1][3]. Regulatory Milestone - The submission of the De Novo request to the FDA is considered a major milestone for the company, marking a significant step towards bringing the DeepView System to the U.S. market [3]. - The project has received support from federal funds through the U.S. Department of Health and Human Services, indicating governmental backing for the development of this innovative technology [3].