Vivos Inc (RDGL)

[Musical Shares]

Why did the FDA grant a Breakdown Device Designation to Radiogel?

It's a good (and fair) question. This is where people get tripped up.

They think a designation from the FDA means something.

This designation can meet many, many products.

That's why the FDA states on their website:

the FDA may find devices that could be good candidates for the Breakthrough Devices Program

And then it also says this:

The FDA recommends that your designation request include:

information to describe the device,
the proposed indication for use,
regulatory history,
how your device meets the statutory criteria for a Breakthrough Device,
and what type of marketing submission you plan to submit to the FDA for your device.

Hundreds upon hundreds of devices can get this designation. It doesn't mean it works. It doesn't mean it's not junk science. It doesn't mean it will ever produce a revenue generating product.