Spectral AI (MDAI) said Tuesday it has completed its pediatric enrollment at US emergency departments for its burn treatment pivotal study.
The study aims to validate the artificial intelligence-driven algorithm used by the company's DeepView System, a device that uses multi-spectral imaging and algorithms to predict burn healing potential, according to the company.
Spectral AI said it plans to use the results of the study to support its De Novo classification request, expected to be submitted to the US Food and Drug Administration within H1.
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