Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D.

Core Insights - Vivos Inc. has appointed Dr. John J. Smith and his team at Hogan Lovells as lead regulatory advisors for the FDA Investigational Device Exemption (IDE) submission for RadioGel® [1][3] Company Overview - Dr. John J. Smith is a board-certified diagnostic radiologist and a recognized FDA regulatory consultant in the medical device sector, currently a partner at Hogan Lovells in Washington, D.C. [2] - The CEO of Vivos Inc., Dr. Michael Korenko, expressed confidence in re-engaging Dr. Smith due to his familiarity with RadioGel® and his expertise in navigating the FDA's review process [3] Product Information - RadioGel® is an innovative injectable device designed to deliver high-dose, localized radiation to tumors safely and effectively [3] - Securing IDE approval is crucial for Vivos Inc. to initiate U.S. clinical trials at the Mayo Clinic, as RadioGel® is not yet authorized for pre-market use [3]