Spectral AI, developer of the AI-driven DeepView System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, announced the completion of its data analytics for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView System for its burn indication. Spectral AI’s DeepView System is a predictive medical device and associated software that assesses the healing potential of burn wounds by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically validated data points. By distinguishing between healing and non-healing tissue, the DeepView System provides an immediate and binary prediction of wound healing on the same day of injury, benefiting clinical decision-making regarding next step treatment.

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The Company announced today that it has completed its data analytics and the results reflect strong metrics of the DeepView System when compared to burn and emergency room physicians in determining the wound healing potential of burns. The Company also notes the following:

  • The Company will pursue a De Novo classification request from the FDA for use of the DeepView System in burn care and expects to submit its De Novo request by June 2025.
  • It has worked with the FDA through numerous pre-submission meetings for guidance and the advancement of its DeepView AI- Burn technology.

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“After completing the image analysis and truthing of our U.S. Burn Pivotal Study, I am highly encouraged by the sensitivity and specificity results of our DeepView System when compared to the wound healing potential as determined by treating physicians,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “These results underscore the transformative impact of the DeepView System and its attendant use of artificial intelligence in burn wound care, offering clinicians an immediate, data-driven assessment tool that can improve treatment decisions and patient outcomes. The dedication of our team in reaching this critical FDA submission milestone cannot be overstated, and we remain committed to bringing this breakthrough technology to burn care institutions across the U.S.”

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Source: Globe Newswire