November 20, 2020
Vivos Inc Applies for Breakthrough Device Designation for Radiogel™
Richland WA, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced that it has completed its submission to the FDA seeking Breakthrough
Device Designation for Radiogel™.
This is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating
diseases or conditions. It is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory
standards for premarket approval or De Novo marketing authorization.
The Breakthrough Designation process takes priority over other FDA meetings, so we elected to submit this application prior to our planned our FDA
Pre-Submission meeting. We intend to schedule the pre-submission meeting in the near future, with no impact to our overall IDE submission effort. It gives us time to gather more data
to share with FDA.
Dr. Mike Korenko stated, “In our opinion RadioGel™ meets the criteria for Breakthrough Device Designation, but we cannot be presumptive about the FDA
determination. If granted, this designation would give RadioGel™ priority review, opening up enhanced FDA communication channels and potentially saving months in the IDE