Core Insights - Spectral AI has completed pediatric enrollment for its U.S. Burn Pivotal Study, one of the largest domestic burn studies aimed at validating the AI-driven algorithm of its DeepView® System for burn indication [1][4] - The company plans to pursue a De Novo classification from the U.S. FDA for the DeepView™ System, with a submission expected in the first half of 2025 [2] - The DeepView™ System utilizes multispectral imaging and an AI-driven algorithm trained on over 340 billion clinically-validated data points to assess burn healing potential, providing immediate predictions to support clinical decision-making [3] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burns and diabetic foot ulcers [4] - The DeepView® System aims to revolutionize wound care management by offering objective assessments of healing potential, which could lead to improved patient outcomes and reduced healthcare costs [4]
Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study