Vivos Inc. (OTCQB: RDGL) announced on Monday, October 27, 2025, that it has appointed Dr. John J. Smith, M.D., J.D., as the company’s lead regulatory advisor for its FDA Investigational Device Exemption (IDE) submission for RadioGel, a groundbreaking injectable device designed to deliver high‑dose, localized radiation to tumors.
Dr. Smith is a board‑certified diagnostic radiologist and former associate professor at Harvard Medical School. He is a partner in the Global Regulatory group at Hogan Lovells, based in Washington, D.C., and has extensive experience with the FDA’s Division of Radiological Imaging and Radiation Therapy Devices review panel. Vivos CEO Michael Korenko said the company is "excited to re‑engage Dr. Smith—someone we have worked with before and who is very familiar with RadioGel," and that his expertise will help address remaining deficiencies in the IDE submission.
The appointment is a strategic regulatory move that positions Vivos to move forward with confidence and clarity toward securing IDE approval, a critical step for initiating U.S. clinical trials at the Mayo Clinic. With RadioGel still not authorized for pre‑market use, the addition of a top FDA regulatory consultant is expected to streamline the review process and increase the likelihood of timely approval, thereby advancing the company’s human clinical development program.
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