Spectral AI, the developer of the AI-driven DeepView® System, has completed pediatric enrollment for its U.S. Burn Pivotal Study—one of the largest domestic burn studies ever conducted. The study aims to validate the AI-powered algorithm behind DeepView™ for burn assessment, moving the company closer to a De Novo classification submission to the FDA in 2025.
Advancing AI-Driven Burn Assessment
- DeepView™ System combines multi-spectral imaging and AI-driven algorithms to predict burn healing potential.
- It provides immediate and binary predictions for wound healing, helping clinicians make informed treatment decisions.
- The system is trained on over 340 billion clinically validated data points, offering unprecedented accuracy in burn evaluation.
Significance of the U.S. Burn Pivotal Study
- One of the largest U.S. burn studies, designed to ensure clinical validation of Spectral AI’s technology.
- Pediatric enrollment marks a key milestone, ensuring comprehensive data collection across all patient demographics.
- The results will support FDA De Novo classification submission in early 2025.
Expert Insights
Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI, emphasized the significance of this study:
“The results of this pivotal study will support our data science team and burn experts in delivering a breakthrough advancement in burn wound assessment to both patients and providers across the U.S.”
What’s Next?
- Spectral AI aims to finalize data analysis and submit the De Novo request to the FDA in the first half of 2025.
- DeepView™ System has the potential to revolutionize burn treatment, improving patient outcomes and clinical efficiency.
Spectral AI’s DeepView™ System represents a significant leap in AI-powered burn assessment, offering faster and more accurate predictions for wound healing. With the U.S. Burn Pivotal Study nearing completion, the company is on track to bring this cutting-edge technology to medical providers nationwide.
