On January 28, 2025, Spectral AI, Inc. announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. This marks another critical step in validating the AI-driven algorithm of the DeepView System for burn indication.
The U.S. Burn Pivotal Study is designed to validate the DeepView System, which uses multispectral imaging and an AI-driven algorithm to predict burn healing potential. The system is trained and tested against a proprietary database of over 340 billion clinically-validated data points.
The data from these patients will be used to pursue a De Novo classification from the U.S. Food and Drug Administration (FDA) for the DeepView System. Spectral AI expects to submit this request in the first half of 2025, bringing the advancement in burn wound assessment closer to patients and providers.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.