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Spectral AI applies to the FDA for approval of an AI tool that predicts burn wound healing.
Spectral AI has submitted an application to the FDA for its DeepView System, a non-invasive burn care tool using AI and multi-spectral imaging to predict wound healing.
This submission seeks De Novo marketing clearance, aiming to offer doctors a new method for assessing burn wound prognosis and making treatment decisions.
The system has previously received Breakthrough Device Designation from the FDA.
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La IA espectral se aplica a la FDA para la aprobación de una herramienta de IA que predice la cicatrización de heridas por quemaduras.