Re-inventing pre-hospital diagnostics of brain and spine injurie
NJ
PONS is an affordable mobile diagnostics tool for brain/spine injuries by utilizing ultrasound technology, in order to provide first responders a tool that they can use on the field
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<p><strong>FDA has recently proposed a regulatory framework for modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). We will follow these guidelines and have discussions with the FDA during this process. </strong></p> <p><strong>https://www.fda.gov/media/122535/download</strong></p>
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