Spectral AI Inc (NASDAQ:MDAI) announced that it has completed the enrollment of adult and pediatric patients at US burn centers for its pivotal study designed to validate the AI algorithm used by its DeepView system for the burn indication.
The company said the data collected from these burn center patients will be used to pursue a De Novo classification from the US Food and Drug Administration (FDA) for the use of the DeepView System in burn centers.
It expects to submit its request to the FDA in the second quarter of 2025.
“We met our burn center enrollment goal much sooner than anticipated due to the dedication of our team and the support of study participants,” Spectral AI CEO Peter Carlson said in a statement.
“This milestone achievement will allow us to begin data analysis and advances our product commercialization timeline.”
Dr Jeffrey Carter, principal investigator of the pivotal study, said the team enrolled 160 patients in less than eight months in what it believes to be one of the fastest enrolling burn studies ever completed in the US.
“The results will be used by our data science team and our panel of burn experts to complete years of work and bring this crucial advancement in burn wound assessment to patients and providers in the US,” Carter said.
Spectral AI said it will continue to enroll patients at emergency departments for the study, which is expected to continue into 2025.
After completing enrollment, associated data analysis, and the receipt of FDA approval for the DeepView System in burn center, it will submit a 510(k) application for the use of the DeepView System in emergency departments.