I reached out and spoke with management today. It was a good chat. Essentially as explained by Disco and the slides the Gen 2 feesability trial will essentially by used to integrate the Gen 2 into existing workflows and test for safety and usability. Access can be given for comparison scans against ground truth but this is not the purpose of the trial. Despite some clients potentially suffering more because of delay treatment will not be administered in this trial on the basis of the scans before being confirmed by the gold standard.
What was interesting was when discussing the equivalent of the Gen 2 pivotal trial which will be a lot smaller than EMU as 510k pathway. However, even in this trial medication will not be administered unless confirmed by ground truth. But in this instance it likely be done via the mobile stroke unit or through an ED department.
Anyway so much going on this month!
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- Ann: EMVision Releases its FY25 Half Yearly Report
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Ann: EMVision Releases its FY25 Half Yearly Report, page-20
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