Vivos Inc. Announces Progress Toward FDA Approval for RadioGel® Therapy

Company aims to submit Investigational Device Exemption for human clinical trials of its precision radionuclide therapy.

Published on Feb. 10, 2026

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Vivos Inc., a medical device company developing the RadioGel® precision radionuclide therapy, has made significant progress toward securing FDA Investigational Device Exemption (IDE) approval for human clinical trials of its innovative technology. The company has engaged a top regulatory expert, addressed FDA feedback, and incorporated new clinical data to strengthen its IDE submission, which it plans to file by the end of Q1 or in April.

Why it matters

RadioGel® is designed to precisely deliver targeted radiation to solid tumors while minimizing exposure to surrounding healthy tissue, potentially offering a more effective and less invasive treatment option for cancer patients. Securing IDE approval would allow Vivos to begin human clinical trials in the U.S., a critical step toward bringing this innovative therapy to market.

The details

Over the past several years, Vivos has engaged extensively with the FDA, addressing feedback from over 40 individual reviewers. The company has finalized key technical parameters related to demonstrating precise delivery of RadioGel® and ensuring minimal exposure to non-target tissues. Vivos has also engaged a top regulatory expert with deep experience guiding similar products through the FDA's approval process. This expert's guidance has helped the company bolster its IDE submission by fully addressing outstanding FDA concerns, incorporating new clinical data, and reformatting pre-clinical data to more effectively address the agency's remaining questions.

  • Vivos plans to submit the IDE by the end of the first quarter or in April 2026.

The players

Vivos Inc.

A medical device company pioneering Precision Radionuclide Therapy™ (PRnT™) with its innovative RadioGel® technology.

Michael K. Korenko

CEO of Vivos Inc.

RadioGel®

A targeted radiation therapy designed to deliver precise, localized beta radiation to solid tumors via direct injection, minimizing exposure to surrounding healthy tissue and reducing systemic migration of the radiopharmaceutical agent.

IsoPet®

Vivos' commercially available veterinary oncology product.

FDA

The U.S. Food and Drug Administration, the regulatory agency that oversees the approval of medical devices.

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What they’re saying

“We are encouraged by the constructive dialogue with the FDA and the substantial progress we have made in fortifying our submission.”

— Michael K. Korenko, CEO of Vivos Inc. (Vivos Inc.)

What’s next

Vivos remains fully committed to advancing RadioGel® toward human clinical trials in the United States and continues its strong collaborations for future indications for use. The company plans to submit the IDE by the end of the first quarter or in April 2026.

The takeaway

Vivos' progress in securing FDA approval for its innovative RadioGel® precision radionuclide therapy represents a significant step forward in bringing a potentially more effective and less invasive cancer treatment option to patients in need.