Vivos Inc (RDGL)

[Arch_Investor]

I JUST DID SOME DIGGING!!!!!

So in the tweet on the picture
It says "we are disappointed to learn FDA did not gran option device BUT criterion 2a was met as a breakthrough technology"

THEREFORE

If you read on FDA if you do not obtain IDE but still qualify for another criterion

"ARE THERE RELATED PRPGRAMS DESIGNED TO EXPEDITE THE AVAILABILITY OF CERTAIN DEVICES THAT MIGHT APPLY TO MY DEVICE"

There is a "safer technologies program" which is what our criterion 2a is

Check out FDA STeP
Directly for Devices and device led combination products (which we are)

Now there are more criteria
1. Not eligible for BDD (which we just met)
2. D) an improvement in the safety of another device or intervention


I BELIEVE WE ARE GOING FOR STeP