Spectral AI Expands Scope of its Burn Study With Additional Sites

Spectral AI Inc. has added three new U.S. clinical trial sites in Texas, Florida, and Alabama to its 2024 burn study.

The new sites are: University Medical Center (UMC) Burn Center at Texas Tech University Health Sciences Center, led by principal investigator Alan Pang, M.D.; Tampa General Hospital Burn Center, led by principal investigator Jared Troy, M.D.; and University of South Alabama (USA) Health Emergency Department, led by Andrew Bright, D.O.
 
These new locations expand the total number of U.S. clinical trial sites to 16. Participating facilities include both burn centers and Emergency Departments (EDs).
 
The 2024 U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by Spectral AI’s DeepView System for burn indication. The study is expected to be the final clinical trial before the company seeks U.S. Food and Drug Administration approval of its DeepView System for burn indication in 2025.

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READ MORE: Spectral AI Surpasses Halfway Point in U.S. Burn Study Enrollment

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“We believe that the potential of our AI-driven DeepView System to support the timely and accurate triage of a burn wound patient in a busy, sometimes chaotic, ED setting can deliver benefits across the healthcare ecosystem,” Spectral AI CEO Peter M. Carlson said. “Having an objective diagnostic tool can lead to immediate interventions that impact the treatment and outcome of burn wounds, while supporting improved institutional efficiencies. The addition of these new sites brings us closer to completing the 2024 Burn Pivotal Study and seeking FDA approval for the DeepView System for burn indication in 2025. We are grateful for the support of these clinicians and institutions in supporting our research and bringing true innovation to burn wound assessment and treatment.”
 
The Company’s DeepView System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that helps healthcare providers assess the healing potential of a burn wound. The U.S. pivotal study is currently enrolling patients at leading burn centers and EDs across the U.S., with principal investigators overseeing the research.
 
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 significantly improve wound care management by “Seeing the Unknown” with its DeepView System. The DeepView System is a predictive device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, the DeepView System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs.