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$2.05 emvision medical devices ltd

Gen 1 is FDA De Novo.Gen 2 is 510(k).

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AgentQ

245 Posts.

92

23/07/24

20:08

Post #: 74880984
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Originally posted by Crusader14: ↑

To clarify, Emvision are taking the 510k pathway rather than De Novo . Previous company presentations had the FDA 510ķ clearance for Gen 1 in FY25. My understanding is it's simpler, faster and cheaper.

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Gen 1 is FDA De Novo.
Gen 2 is 510(k).

EMV Price at posting: $1.99 Sentiment: Buy Disclosure: Held
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