STARMED Secures First FDA Clearance for Thyroid RFA in U.S.

The regulatory approval covers the VIVA combo RF generator alongside the star and VIVA RF electrodes. These tools allow for ultrasound-guided, percutaneous ablation of benign, symptomatic thyroid nodules in adults. By offering a minimally invasive, outpatient alternative, the technology preserves thyroid function and bypasses the risks associated with traditional surgical intervention.

This milestone follows a 24-year clinical trajectory that began in 2002, when Dr. Jung Hwan Baek utilized STARMED equipment for the world’s inaugural thyroid RFA procedure in South Korea. The recent U.S. clearance, granted on May 26, 2026, was backed by a systematic review of 42 peer-reviewed studies. Each study demonstrated a volume reduction ratio of at least 50% at six months, the established clinical benchmark for significant symptom relief. Beyond the clinical benefits, the FDA designation is expected to streamline institutional adoption and align CPT coding pathways for physicians across the country.