Spectral AI, Inc. announced the enrollment of the first patient in the pivotal study to validate DeepView AI® using its proprietary imaging technology for burn size and healing assessment. This pivotal study is expected to be the final clinical trial before seeking FDA marketing authorization for the burn indication in 2025 and will be conducted in burn centers and emergency departments across the US, enrolling both adults and pediatric patients. The data obtained in the study will be compared to assessment by physicians and used for regulatory submission to the FDA by the first half of 2025.

This project is being supported in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00049. The findings and conclusions have not been formally disseminated by HHS and should not be construed to represent any agency determination or policy.