Spectral AI Inc (NASDAQ:MDAI), a company specializing in AI-driven medical diagnostics, has announced the completion of pediatric patient enrollment for its 2024 pivotal study.
The study aims to validate the AI algorithm of its DeepView System for burn indications and is set to conclude in the fourth quarter of 2024.
The trial is the final step before the company seeks FDA approval for the system in 2025.
The study reached its pediatric enrollment goals for burn centers at an “unprecedented” six months, lead investigator Jeffrey Carter said.
“Burn wounds can be devastating, especially for children who are particularly vulnerable to these injuries. Empowering clinicians to deliver an immediate, accurate assessment of pediatric burn wounds is of critical importance,” said Peter Carlson, CEO of Spectral AI.
The DeepView System uses proprietary multispectral imaging and a vast database of over 340 billion clinically validated data points to differentiate between healthy and damaged tissue. Designed for immediate use upon a child's arrival at an emergency department or burn center, the non-invasive, cart-based system offers swift and accurate wound assessments, aiding timely clinical decisions and minimizing the trauma of moving injured children.
“We believe that the DeepView System, powered by our proprietary AI-driven algorithm, has the potential to change the standard of burn care by supporting early treatment decisions that can lead to improved patient outcomes,” Carlson added.
The study continues to enroll adult patients and pediatric patients through emergency departments to further validate the DeepView algorithm.