Vivos Inc (RDGL)

[pumper_stumper]

Got a confirmation letter back from the FDA yesterday! The letter thanked me for providing information to them.

It was a response to this:

July 25, 2025

Dear FDA:

I am writing to supply some additional information regarding the IDE application that the FDA has before it, from Vivos Inc, especially in light of this administration's America First efforts!

It is upsetting, as an American, to see an American company such as Vivos going out its way to test medical products overseas, and then coming to the US FDA in for approvals!  These are jobs, projects, and revenue that are going overseas rather than to Americans!   What could be a better example of going against the America First efforts as this?  Clearly there are scores of companies that would be able to perform the testing in the United States.   Vivos is choosing to go overseas to save money and almost certainly to take advantage of lower standards there!

In addition, note that this company has one employee, the CEO Mr Korenko, who previously worked under a Democratic administration, under Carter!   To this day, paid promoters of this company proudly post online about of the relations between Mr Korenko and the Democratic President, showing pictures of them together!

Lastly, although not under the jurisdiction of the FDA, I think there should be significant tariffs put on projects like this that are being done overseas! Please bring this suggestion forward to top levels of this administration to be considered!

Please make sure those that are involved in evaluating the Vivos IDE are fully aware of these facts when reviewing this current IDE application, as well as any future applications to the FDA!