Vivos Inc (RDGL)

[chereb19]

The FDA granted a breakthrough device designation for a reason.

They wouldn't do it on a whim, VIVOS have presented enough data to show that Radiogel is safe and effective.

“We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness.
This is why Radiogel is one of only 20 odd Radiology devices EVER to be granted a BDD.