Vivos Inc (RDGL)

[Tcsxyz]

De Novo (the classification that RDGL is seeking
Not once, not ever, nor will a de novo be passed to allow human clearance without clinicals for a gel that congeals in a polymar form that contains nuclear medicine that must be injected into a cancerous tumor.

Show any de novo in this class that has been approved that contains just two of the three of these
Injected surgical procedure
Polymer
Nuclear medicine

There isn’t. There won’t be any that passes with all 3. This has failed twice with ADMD and once with a company before RDGL FDA. Submitting it for a 4th time bc they did animal trials for a 2nd time won’t yield any different results.

The fact they have spent this many years doing this and resubmitting the same data that Battelle knew already years ago is very telling