Vivos Inc (RDGL)

[kayak_wench]

Been reading about the BDD more this morning. Getting that designation was certainly a boon for the company. Recall the path Vivos anticpates taking is to apply for a De Novo marketing authorization. I cannot find anything about IDE submission of devices that qualify as BDDs. I'm beginning to think that is because that first step is a relative non-issue.

The increase of breakthrough device designations has allowed more products to get to the commercial market in a shorter amount of time. Under the breakthrough device program, the average time for review of a 510(k) clearance decreased by more than 50%, down from 270 days to 155 days. Similarly, the breakthrough device program has decreased time to grant for a De Novo marketing authorization by 68 days, a decrease of more than 25%.