Vivos Inc. FDA IDE Approval

Vivo, a medical device company developing Yttrium-90 Precision Radionuclide Therapy, announced on July 27, 2026, that it received FDA approval for its Feasibility Investigational Device Exemption (IDE) application on July 22, 2026. This clearance allows Vivos to initiate a first-in-human feasibility study at Mayo Clinic in Jacksonville, Florida, targeting patients with non-resectable papillary thyroid carcinoma. The study will enroll five patients and aligns with Vivos' Breakthrough Device Designation. The FDA also reduced the safety follow-up period from five years to 24 months. In India, clinical trials at Avon Healthcare Limited (HGC) were temporarily paused due to an internal audit, but approvals remain in place; Vivos expects DCGI approval to resume treatments by end of 2026. The company's animal therapy business continues to expand, with 17 certified clinics treating over 200 animals. Manufacturing validation at APEL in Richland, WA is nearing completion, and a contract has been executed with a supplier in India to replicate production capabilities. Vivos also highlighted the PrecisionGel opportunity, with Akina Inc. submitting a paper for publication.