Spectral AI Expands Clinical Trials and Achieves Enrollment Goals
Spectral AI's Progress in Clinical Trials
DALLAS — Spectral AI, Inc. (NASDAQ: MDAI), an innovative company specializing in artificial intelligence for medical diagnostics, is making significant strides in its U.S. Burn Pivotal Study. The Company has recently announced that it reached an impressive milestone with 25% patient enrollment at Emergency Departments (EDs) across various states. To boost its research capabilities and patient outreach, Spectral AI also introduced two new clinical trial sites — MedStar Washington Hospital Center and the University of Utah.
Expanding the Reach of the Burn Study
The current study is one of the largest burn-related trials conducted in the United States, aimed at validating the advanced AI-driven algorithm employed by Spectral AI's DeepView System, particularly the version for burn assessment known as DeepView AI-Burn. This algorithm aims to assist medical professionals by providing rapid, reliable analyses of burn injuries, thereby enabling quicker treatment decisions.
Advancing Treatment Accessibility
Peter M. Carlson, the Chief Executive Officer of Spectral AI, highlighted the growing need for effective burn care. He stated, “Access to specialized burn treatment in the United States has declined significantly. Therefore, ED clinicians are increasingly responsible for evaluating burn wounds at the first point of care. Our DeepView AI-Burn tool is designed to support these clinicians, effectively bridging the gap of expertise in a fast-paced ED environment.”
Pathway to FDA Approval
Prior to this new development, Spectral AI had successfully completed recruitment for both adult and pediatric patients at established burn centers. The data collected from these patients will be pivotal for the Company’s upcoming De Novo submission to the U.S. Food and Drug Administration (FDA). This submission will request the classification of the DeepView AI-Burn as a Class II medical device, with expectations to complete the filing by mid-2025.
Innovative Technology in Wound Care
Spectral AI's DeepView System plays a crucial role in wound assessment, distinguishing between healing and non-healing tissue. Its primary advantage is providing clinicians with immediate, binary predictions regarding wound healing status on Day One. This early assessment can shape the subsequent course of treatment and improve overall patient outcomes.
About Spectral AI
Founded in Dallas, Spectral AI, Inc. is dedicated to transforming wound care diagnostics using predictive AI technology. By integrating advanced algorithms into daily clinical use, the Company aims to enhance treatment protocols for patients suffering from burns and diabetic foot ulcers. The vision is to empower healthcare providers by delivering clear insights that lead to proactive, efficient medical interventions.
Frequently Asked Questions
What is the significance of the 25% patient enrollment?
Achieving 25% patient enrollment indicates significant participation in the U.S. Burn Pivotal Study, showing progress toward their research objectives.
How does the DeepView AI-Burn system function?
It utilizes advanced algorithms to quickly differentiate between healing and non-healing tissue, enabling timely and informed treatment decisions.
What are the new clinical trial sites added?
The recent additions are MedStar Washington Hospital Center and the University of Utah, expanding the study's geographic reach.
What is the expected timeline for FDA approval?
Spectral AI anticipates submitting their De Novo request to the FDA in the second quarter of 2025.
What potential impact does this technology have on wound care?
This technology aims to improve clinical decision-making, streamline treatment plans, and ultimately enhance patient outcomes and comfort.
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