Ann: PRE-SUBMISSION MEETING WITH US FDA FOR HEART FAILURE, page-30

  1. 314 Posts.
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    @Rorbag
    It is likely due to the fact that they have already cleared the software for AS. I believe this was touched on in a recent webinar. When they sought FDA approval for AS the FDA were seeing the tech for the first time surely resulting in a more rigorous approval process. It's the same software for HF, works the same way, just different data points. If they have the study to back it up then the approval process is really just a formality.
    Last edited by Tristan576: 26/01/25
 
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