Investigational Device Exemption (IDE) Application for Human Clinical Trials at Mayo Declined By FDA
Kennewick, WA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL) Following the 30-day review period, the FDA declined approval of the Radiogel® IDE submission.
We are now focused on addressing the items we received in the FDA letter and will have an initial call with the FDA within 10 days as provided in the FDA correspondence. We also intend to participate in a pre-sub meeting with the FDA review team in the coming weeks, with the goal of resubmitting the application for the IDE. Radiogel® received the FDA Breakthrough Device Designation and has demonstrated an unparalleled therapeutic ratio and strong safety profile. Vivos remains committed to pursuing approval for Radiogel® in the US market.
Michael K. Korenko, Sc.D.
President & CEO, Vivos Inc.
Email: MKorenko@RadioGel.com
Follow Vivos Inc. on X (Twitter): @VivosIncUSA
Learn more about RadioGel® and IsoPet® at www.VivosInc.com
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