Replies to post #176777 on Vivos Inc (RDGL)

[mc73]

In that case, I would expect Mayo to assist, as someone else said.

[Truthsocial]

Dont listen to lost and lollipop
This information has been posted at nauseum...take your FUD and .

The FUDSTERS are trying like cockroaches

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-institutional-review-boards-irb

Mayo is waiting for FDA APPROVAL of course you know that or not
MAYO IS READY TO GO
FULL STOP

Mayo clinics IRB has been with Dr Korenko and rdgl throughout this process so we are good to go
Mayo has completed the practice protocol with dummies....
Now we go live ....imo

[den4]

Mayo is waiting for FDA approval.. They want to start asap !! Vivos has already send the clinic trial protocols to the IRB gatekeepers for comments in anticipation of fda approval.. everything is prepared.. just waiting on fda green light

[Gobsmacked01]

My thoughts are to wonder how the RDGL device is being treated by the FDA?

In other words Brachytherapy is not some new device... it has a decades long history.
Y90 is not a new radioisotope for cancer treatment... it has a long history as well.

The gel is an original formulation and the Y90 is far more pure than currently approved bead brachytherapy solutions.

Is FDA approving this as a new device? A new formulation for an already approved device? A human safety improvement from category 3 to 2 (more safe) for an existing device use justified by the Breakthrough Device Designation?

The answers could significantly affect/shorten the typical timeline here, no?

Discuss /explain if anyone here is up on all that stuff please?

- Go $RDGL