Pinned straw:
@Chagsy , I went back to all CY 2024 and CY2025 EMV announcements around diagnostic performance. Figured that anything prior to that would not be terribly useful. Attached the links to the announcements as there is medical-related information that you may make better sense of.
Being completely clueless in all things medical, from an investment perspective, I have relied on the following to feel comfortable that things are progressing well in the lead up to FDA De Novo approval. The underlying assumption is that if there was anything fundamentally wrong, medically, which would threaten the viability of EMU or First Responder, one or some of these "channels" would have raised concern which EMV will have had to disclose as part of continuous disclosure requirements.
The planets have aligned across these various channels, giving me good confidence to stay invested.
The pivotal trial results would provide the next set of results and will be watching those more closely around what you have flagged.
27 Mar 2024
https://wcsecure.weblink.com.au/pdf/EMV/02789241.pdf

27 May 2024
https://wcsecure.weblink.com.au/pdf/EMV/02810628.pdf

12 Nov 2024
https://wcsecure.weblink.com.au/pdf/EMV/02879465.pdf

21 May 2025
https://wcsecure.weblink.com.au/pdf/EMV/02948705.pdf

Thanks @jcmleng
its a really interesting device. Please see my bear case from 4 years ago as to why I do not think it has a future in acute ischaemic stroke. Traumatic ICB (intracranial bleed) seems a far more rational target, but to change direction now would be challenging to say the least
I am puzzled by the quoted sensitivity of 85% for ischaemic stroke that they have provided. On the data provided it is 60%, which ain’t much better than flipping a coin:

20 patients had ischaemic stroke, EMV correctly identified 12 (True Positives) and missed 8 (False Negatives)
TP = 12
FN = 8
=> 12/12+8 = 0.6 or 60%
Maybe I’m missing something?