Interesting interview re Minicare system, page-7

  1. 5,891 Posts.
    When talking about regulatory approval :

    "We hope by the end of this year to be able to start the formal clinical trials. We will start in Europe"

    The EU process is much quicker than the FDA process so this makes sense

    The fast track approval can be done in I think 45 business days - Not 100% sure but I know it is quicker than fda


    "We completed a feasibility field study at one of the biggest centers for cardiology, a leading cardiology center in Holland, Catharina Hospital"

    Feasability study - sounds familiar
 
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