Spectral AI announced on December 2, 2024, the successful completion of truthing for all images gathered from burn centers across the United States. This milestone is crucial for training the company's proprietary DeepView System to accurately predict wound healing outcomes.
Following the completion for burn centers, Spectral AI is now initiating the truthing process for images collected from emergency departments and emergency rooms nationwide. This expansion aims to broaden the DeepView System's capabilities to a wider range of clinical scenarios.
The company anticipates data results in late December 2024 to support an FDA De Novo submission in the first half of 2025. This submission seeks to classify the DeepView AI-Burn system as a Class II medical device, enabling faster and more accurate burn-depth assessments.
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