Vivos Inc (RDGL)

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The requirement that a device must provide substantial improvement or address unmet needs implies that a highly effective or distinct approach, aka novel, is essential to meet these rigorous standards.

You are just digging yourself a hole here. 🤣

I think you should re-read the part under "Is My Device Eligible?" again.

There are two criterions. The first criterion everyone has to meet. The second criterion you only need to have at least one of those (there is 4 to pick from).

So, if a BDD was to be issued it doesn't have to meet what you call "novelty." 🤣