It depends on the application pathway - 510k ( for medical devices where 'substantial equivalence' to existing devices can be demonstrated)), PMA (for high risk medical devices) or De Novo (for novel medical devices for which there is no legally marketed predicate device)
EMU is on the De Novo pathway.
As I wrote in a post last week, "FDA assessment of application (noting that the mean decision time for the 374 De Novo requests from 1997 to Aug 2023 was 338 days – with a range from 28 days to 900 days)"
So take your pick within that range. No-one knows for sure, not even Scott. But what I do see is the Company leaving no stone unturned in seeking a problem free approval timeline.
EMV Price at posting:
$2.15 Sentiment: Buy Disclosure: Held
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