Spectral AI (MDAI) announced the completion of its pediatric enrollment at U.S. emergency departments 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. FDA for use of the DeepView System and expects to submit the request in the first half of 2025.
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