6.13 Webinar Feedback https://www.poctrn.org/zh/c/message_boards/find_thread?p_l_id=864599&threadId=1030162 2026-06-11T05:16:05Z 2026-06-11T05:16:05Z Marshall Collins https://www.poctrn.org/zh/c/message_boards/find_message?p_l_id=864599&messageId=1030161 2019-06-13T20:10:00Z 2019-06-13T20:10:00Z

- agree no predicates on the market for ASD diagnosis    <br />    -cognoa: company received breakthru device(2018), expected to be de novo<br />    - device for ASD<br />    - if they get cleared, they could be predicate<br />        - first point is intended use, diagnosis of autism would fit this, second is technological characteristics<br />            -510(k) can show that there&#39;s no danger<br />    - demonstrate your device is eligible to provide more effective to diagnose<br />- well done mapping the needs insight<br />- problem is solving the 6 month delay<br />    - what&#39;s the cause? <br />    - how does your solution fit in?<br />- as an investor, it&#39;s not clear about how you can influence the wait time<br />- you created a clear value proposition, but now you have to show evidence of this<br />- careful with claims slide, need to be clear what will actually be done

Marshall Collins 2019-06-13T20:10:00Z