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Ann: Update on ePAT for Infant Apps-MNQ.AX, page-12

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  1. 980 Posts.
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    Gathering clinical evidence is the most expensive part of commercialising a medical app not submitting an application to the FDA.

    ResApp will need to submit an application per disease starting off with pneumonia next quarter. Each algorithm will need to be approved by the FDA for each disease and will require seperate clinical evidence.

    ePat are not diagnosing a life threatening disease, they are providing a tool to aid the assessment of pain and ultimately will need to submit less FDA submissions than RAP.
    Last edited by RNClarke: 06/06/16
 
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