Spectral AI completes Pediatric enrollment for U.S. Burn Pivotal Study in Emergency Departments

Spectral AI , developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today 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. Food and Drug Administration (“FDA”) for use of the DeepView™ System and expects to submit the request in the first half of 2025.

Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView™ System provides an immediate and binary prediction of wound healing at examination that can support clinical decision-making regarding next step treatment plans.

“I am proud of the continuing work by our investigators, their dedicated staff and most critically study enrollees,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “The results of this U.S. Burn Pivotal Study will be used by our data science team and our panel of burn experts to complete years of work and bring this crucial advancement in burn wound assessment to patients and providers in the U.S.”