EMV emvision medical devices ltd

Ann: Australian Stroke Alliance & FDA Update, page-5

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    MRFF
    - Competitive funding process remains on foot
    - Early 2021 announcement for successful bids

    FDA
    - 513(g) RFI submitted as previously noted
    - Purpose: seek FDA guidance on what product classification would be most appropriate for EMV's Gen 2 portable brain scanner device and what appropriate regulatory pathway will be
    - In dialogue with FDA
    - FDA aware response is overdue
    - Anticipate response no later than early 2021

    https://hotcopper.com.au/data/attachments/2749/2749748-102c7de10c7138f1bce46d835cc044e6.jpg
 
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