Vivos Inc (RDGL)

[MattTheRose]

No. That's not the way it works at all. They sent the application for the device, but when a device is considered A.) "too new", having no other comparable device on the market, or B.) if the FDA feels is it not safe enough and requires further study, it is AUTOMATICALLY classified as a Class III. The FDA is not "suggesting" anything to "help" AIMC, this is simply protocol. If your device uses an unfamiliar silvery method or it is deemed high risk, it is automatically classified as Class III. What WE are waiting for is the De Novo process by which AIMC can say "Oh it's really not that risky because A.) here are similar devices in the current market which work just like ours and are deemed safe, or B.) here's the research which proves that our device is safe, even though it's deliver method is technically new to the market.

Basically AMIC needs to convince the FDA that their product is safe enough to not be class III and require funding for more testing and reapplication.