Spectral AI completes burn center enrollment for U.S. Burn Pivotal Study

Spectral AI announced the completion of adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView System for burn indication. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration for use of the DeepView System in burn centers and expects to submit the request in the second quarter of 2025.