The AI-based imaging system is designed to help clinicians assess burn wound healing potential and identify wounds that may require intervention.
Spectral AI announced that the US Food and Drug Administration granted De Novo classification for the company’s DeepView System, an AI-based imaging device intended for burn assessment.
With the De Novo classification, the company is authorized to begin commercial distribution of the device in the United States. The DeepView System is intended for use in burn care settings including burn centers, trauma centers, and emergency departments.
“We are pleased that the FDA has recognized our novel technology,” says Vincent Capone, CEO of Spectral AI, in a release. “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.”
According to the company, the noninvasive DeepView System combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of burn wounds. The system is designed to help clinicians identify wounds that are unlikely to heal within 21 days and may require significant medical intervention.
Spectral AI says image acquisition takes 0.2 seconds, while image processing and AI model classification take approximately 20 to 25 seconds. The company says the system was trained and tested using a proprietary 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 Dr J Michael DiMaio, chairman of the board of Spectral AI, in a release. “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.”
The project received support from the Biomedical Advanced Research and Development Authority under a contract with the Department of Health and Human Services.
Photo caption: DeepView System
Photo credit: Spectral AI
