RFA Device Gains FDA Clearance for Minimally Invasive Thyroid Nodule Ablation

STARMED America received U.S. Food and Drug Administration (FDA) 510(k) clearance for the VIVA combo RF generator used with star RF Electrodes and VIVA RF Electrodes, representing the first device indication in the United States specifically for radiofrequency ablation (RFA) of thyroid nodules. 

The labeling covers ultrasound-guided percutaneous ablation of cytologically confirmed benign thyroid nodules in adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. For autonomously functioning nodules, the indication applies when nodule volume is less than 10 mL. STARMED is currently the only company in the country to hold this specific indication.

The system is intended for use under real-time ultrasound guidance, pairing the VIVA combo RF Generator with compatible RF electrodes to perform percutaneous ablation. Thyroid RFA is a minimally invasive, outpatient alternative to surgery that preserves the thyroid. The clearance may also support hospital value analysis and institutional adoption by aligning device labeling, clinical evidence, and Current Procedural Terminology (CPT) coding pathways for thyroid RFA. 

The clearance was supported by a systematic literature review of 42 peer‑reviewed publications, each reporting a thyroid nodule volume reduction ratio of at least 50% at six months, described as the clinical benchmark for meaningful symptom relief. STARMED reports its devices have been cited in more than 300 clinical publications worldwide. 

“From the first thyroid RFA procedure ever performed to the first FDA indication in U.S. history, STARMED has been the equipment behind the science. This clearance reflects the trust physicians and researchers around the world have placed in our technology for more than two decades,” said Henry Shin, CEO of STARMED Co., Ltd.