Spectral AI has completed the data analysis for its pivotal Burn Study, in the US, designed for the validation of its DeepView System's artificial intelligence (AI)-powered algorithm for burn indication.

The outcomes showed that the system's metrics are “strong” against burn and emergency room physicians in determining burn healing potential.

The predictive medical device DeepView System with associated software evaluates burn wound healing potential using multispectral imaging combined with an AI-powered algorithm trained on over 340 billion data points that are validated clinically.

It offers an “immediate” as well as binary prediction of wound healing potential on the day of injury, which aids clinicians in making informed decisions regarding treatment, noted the company.

The company also said that it will pursue a De Novo classification request from the Food and Drug Administration (FDA) for the system’s use in burn care, anticipating the submission of the request by June this year.

To advance the system’s AI-Burn technology, the company worked with the US regulator through multiple pre-submission meetings.

Spectral AI board chairman Dr Michael DiMaio said: “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.”

Spectral AI is focused on medical diagnostics to enable “accurate” and “faster” wound care treatment decisions.

In July last year, Spectral AI expanded its clinical trial activities by adding three new sites to the US pivotal study assessing the DeepView AI-based diagnostics platform.