Spectral AI has announced the completion of data analytics for its US Burn Pivotal Study to validate the artificial intelligence (AI)-driven algorithm used by the DeepView System for its burn indication.
DeepView System, an AI-driven medical device and associated software, uses multi-spectral imaging and algorithms to predict burn wound healing potential.
The predictive medical device was granted breakthrough device designation from the US Food and Drug Administration (FDA) in 2018.
The system has been tested against a proprietary database of over 340 billion clinically validated data points to predict healing outcomes.
It is designed to quickly distinguish between healing and non-healing tissue, offering an immediate, binary prediction of wound healing on the same day of injury. This helps clinicians make informed decisions for the next steps in treatment, Spectral AI said.
According to Spectral AI, its data analytics showed strong performance of the DeepView System in comparison to burn and emergency room physicians when predicting burn wound healing.
The Dallas-based predictive AI company also stated that it plans to submit a De Novo classification request to the FDA for the use of the system in burn care by June 2025.
Additionally, the company had several pre-submission meetings with the FDA to receive guidance and further advance its DeepView AI-Burn technology.
Spectral AI board chairman Michael DiMaio said: “After completing the image analysis and truthing of our US 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.
“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 US.”
Last month, the predictive AI company completed its paediatric enrolment at US emergency departments for its US Burn Pivotal Study.
In November last year, Spectral AI raised $5m in financing to bolster the financial position for the FDA pathway of its imaging system.
