I understand what is being suggested. What I don't understand is how any worthwhile regulatory authority would accept that.
What we are suggesting is that we do a validation study to prove our system works following a FDA approved approach for haemorrhage only. We then plan to modify our validated system by changing the algorithm before asking for approval using data outside the FDA controlled environment. To me, this means it is no longer validated. AI is good, but it does make mistakes. Would the FDA just trust it is better?
EMV Price at posting:
$1.74 Sentiment: Buy Disclosure: Held
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