Spectral AI, Inc., an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announced that it has added two new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study: the University of California San Diego and the University of Utah.
These new locations expand the total number of U.S. Clinical Trial Sites to 14.
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“These two new sites allow us to capture additional burn patients who enter through the Emergency Department and thus complement our existing trial site presence at burn centers across the country, establish our presence in new geographies, and advance us towards our objective of completing this study by the end of the year,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “Moreover, a broader base of clinical trial sites provides access to a more diverse patient population, reduces bias, and provides the opportunity to elevate the profile of our DeepView™ System across a wider range of clinicians and healthcare settings.”
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 scheduled to be completed in the fourth quarter of 2024 and it is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025.
Spectral AI’s CEO Peter Carlson said: “These two new sites allow us to capture additional burn patients who enter through the emergency department and thus complement our existing trial site presence at burn centres across the country, establish our presence in new geographies, and advance us towards our objective of completing this study by the end of the year.”