New York, June 6, 2024 - PRISM MarketView - The AI wound care medical company, SpectralAI (MDAI) is also a PRISM NextGen Tech and AI Index company and has announced it’s reached 50% enrollment at burn centers for its ongoing US burn study. This study is designed to test and validate the SpectralAI DeepView System algorithm that is used for burn indications.
The study is aiming enrollment of 240 patients across old and young and should be the final trial before the company seeks FDA approval in 2025. 024 pivotal study designed to validate the algorithm used by its DeepView™ System for burn indication. This pivotal study, which is targeting enrollment of 240 patients, including both adult and pediatric subjects at multiple burn centers and emergency departments across the U.S., is expected to be the final clinical trial before seeking FDA approval in 2025.
The DeepView System image processing algorithm employs multispectral imaging, leveraging a proprietary database containing over 340 billion clinically validated data points. This advanced technology provides a quick and objective evaluation, assisting healthcare providers in determining the healing potential of burn wounds.
“We are committed to advancing burn care through the implementation of innovative technologies and rigorous clinical research. Our objective is to deliver to healthcare providers the cutting-edge tools they need to enhance their ability to immediately and accurately assess a burn wound’s healing potential. We are enthusiastic about the achievement of this enrollment milestone as we aim to demonstrate DeepView’s AI effectiveness in providing accurate wound assessments and timely clinical decision-making for burn injuries.”
Mary Regan, VP of Medical Affairs at Spectral AI
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