The system utilizes multispectral imaging and algorithms to help clinicians determine the healing potential of burn wounds.
The US Food and Drug Administration (FDA) has granted De Novo classification for the DeepView System, authorizing Spectral AI to begin commercial distribution in the US. The system is designed for burn care assessment in various clinical settings, including burn centers, trauma centers, and emergency departments.
The technology is intended to provide clinicians with a diagnostic assessment of a burn wound’s healing potential on the first day of care.
“Our ability to obtain FDA De Novo classification is a defining moment in Spectral AI’s history and a validation of our shared vision to bring to market our innovative predictive medical technology that provides a day-one diagnostic assessment of a burn wound’s healing potential,” says Vincent Capone, CEO, in a release.
Multispectral Imaging and AI Integration
The DeepView System is a non-invasive medical device that combines multispectral imaging with a proprietary AI algorithm. It provides an immediate, data-driven assessment of whether areas within a burn are unlikely to heal within 21 days, which may indicate the need for medical intervention.
According to the company, image acquisition takes 0.2 seconds, while image processing and AI model classification are completed in approximately 20 to 25 seconds. The system was trained and tested against a database containing more than 340 billion pixels of burn wound image data.
“Today we celebrate a watershed moment in the history of Spectral AI,” says J. Michael DiMaio, chairman of the board of Spectral AI, in a release. “Adhering to a mantra of ‘Finance, Focus, and Finish,’ we are now positioned to commence commercialization of the DeepView System, which we believe has the potential to redefine the standard of care in the assessment and treatment of burn wounds. We are confident that this pioneering technology will provide value across the healthcare ecosystem by improving patient outcomes and aligning care quality with cost efficiency.”
Federal Support and Development
The development of the DeepView System was supported in part by federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
Spectral AI, based in Dallas, is a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications for patients with burns.
