Crusader - Agent is correct. EMvision has never deviated from the de Novo pathway since receiving guidance from FDA in early 2021 and announcing it (FDA Provides De Novo Guidance) on 25 Jan 2021.
Similarly EMV has always articulated the 510k pathway for Gen 2, because of the predicate device in the form of the Gen 1 EMU.
Crusader - Agent is correct. EMvision has never deviated from...
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