Two New Sites Added to Spectral AI’s U.S. Burn Study

Spectral AI Inc. has achieved a 25% patient enrollment at hospital emergency departments (ED) for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the trial is designed to validate the AI-driven algorithm used by the company’s DeepView System for burn indications (DeepView AI-Burn).
 
In conjunction with the patient enrollment milestone, Spectral AI added two new ED Clinical Trial sites for this study: MedStar Washington Hospital Center (Washington, D.C.) led by principal investigator Shawn Tejiram, M.D.; and the University of Utah led by principal investigator Giavonni Lewis, M.D. The addition of these two clinical research sites expands the total number of participating EDs to 11 facilities. 

“We are continuing to build momentum and advance towards achieving our ED enrollment goals,” Spectral AI CEO Peter M. Carlson said. “Access to specialized burn treatment in the United States has declined significantly, resulting in an increasing number of front-line ED clinicians assuming the initial responsibility of assessing the severity and healing trajectory of a burn wound. We believe that the use of DeepView AI-Burn can deliver burn expert-level clinical support to a busy, oftentimes chaotic, ED setting.”
 
The company has completed both adult and pediatric patient enrollment at U.S. burn centers for the U.S. Burn Pivotal Study. Using data from these burn center patients, the firm will pursue a De Novo submission to the U.S. Food and Drug Administration (FDA) to classify DeepView AI-Burn as a Class II medical device. The company expects to submit this request to the FDA in Q2 2025.
 
Spectral AI’s DeepView System for burn indication is designed to distinguish between healing and non-healing tissue by providing an immediate and binary prediction of wound healing on Day One that can support clinical decision-making regarding next step treatment plans.
 
Spectral AI Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The company is working to revolutionize the management of wound care by “Seeing the Unknown” with its DeepView System, a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential before treatment or other medical intervention. With algorithm-driven results, the DeepView System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.