Vivos Inc (RDGL)

[overunder]

Thank You for pointing that out to me. The article I posted was from 2016. It was more for information on the process rather than the time lines. It did mention this though.

In May 2015, the U.S. House of Representatives passed the 21st Century Cures Act (23) that, in addition to other measures, permits certain medical device approvals on the basis of observational studies and “clinical experience” rather than randomized controlled trials. The act was intended to reduce the time and expense of device approval, but it has raised serious concerns about whether the safety and efficacy of medical devices will be compromised 24, 25.