Vivos Inc. Retains Top FDA Regulatory Expert Dr. John J. Smith, M.D., J.D., to Support IDE Submission for RadioGel®

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 their product RadioGel [1][3] - Dr. Smith is a recognized expert in FDA regulatory consulting within the medical device sector and has prior experience with Vivos [2][3] - RadioGel is an innovative injectable device aimed at delivering high-dose, localized radiation to tumors, and obtaining IDE approval is essential for starting U.S. clinical trials at the Mayo Clinic [3] Company Developments - The appointment of Dr. Smith is expected to enhance Vivos' confidence and clarity in addressing remaining deficiencies in their IDE submission [3] - RadioGel is currently not authorized for pre-market use, indicating that regulatory approval is a critical step for the company [3]