Spectral AI Inc (NASDAQ:MDAI) announced that it has achieved 50% clinical trial site enrollment for its pivotal Deepview System study.
The DeepView System’s image processing algorithm uses multispectral imaging, which has been trained on a proprietary database of more than 340 billion data points, to aid healthcare providers in assessing the healing potential of a burn wound.
The study, which is targeting the enrollment of 240 patients, is expected to be the final clinical trial before the company seeks Food and Drug Administration approval for the system in 2025.
It will enroll both adult and pediatric patients at multiple burn centers and emergency departments across the US.
The study’s objectives are to validate the standalone performance of the DeepView System’s algorithm on an independent dataset and compare it against existing clinical assessment, as quantified by clinician judgment annotations.
“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,” Spectral AI VP of Medical Affairs Mary Regan said.
“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.”
Dr Kathleen Romanowski, principal investigator at one of the clinical trial sites, the UC Davis Firefighters Burn Institute Regional Burn Center, added: “DeepView's technology has the potential to significantly enhance our ability to assess burn wounds accurately, leading to improved patient outcomes and quality of life.”