Vivos wins FDA clearance for feasibility IDE in RadioGel thyroid cancer study
RDGL•Follow-up period shortened
FDA cut the required safety follow-up to 24 months from five years, supporting faster planning for subsequent pivotal studies.
FDA clearance for first-in-human study
Vivos won FDA clearance for a Feasibility IDE on July 22, 2026, enabling a first-in-human RadioGel study at Mayo Clinic in Florida.
The trial targets non-resectable papillary thyroid carcinoma. Initial enrollment is set at five patients to assess safety and feasibility.
India trials paused during internal audit
In India, trials at HGC were paused during an internal audit. Approvals remain in place. The DCGI restart decision is expected by the end of 2026.
