Vivos Inc. Files Early Feasibility IDE Application with FDA for Radiogel™
September 20, 2021 at 07:00 pm IST
Vivos Inc. submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel™, to the Food and Drug Administration as part of a pre-submission meeting process. The FDA recommended this path to facilitate enhanced ongoing communication with Vivos and to increase the efficiency of the review process. This review typically takes several iterations and will continue with biocompatibility testing in parallel.