- STARMED is the first company, and currently the only one, with an FDA indication for RFA of thyroid nodules in the U.S.
- Clinical efficacy supported by 300+ clinical publications using STARMED equipment.
Thyroid nodules affect an estimated 65% of the U.S. population. Until now, patients requiring intervention faced a choice between monitoring or surgery. Thyroid RFA offers a minimally invasive, outpatient alternative that preserves the thyroid and avoids surgery.
The cleared devices — the VIVA combo RF generator, star RF Electrodes, and VIVA RF Electrodes— are now indicated for ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules in adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. Autonomously functioning nodules are indicated if nodule volume is less than 10 mL. The clearance was supported by a systematic literature review of 42 peer-reviewed publications, each demonstrating a volume reduction ratio (VRR) of ≥ 50% at six months — the clinical benchmark for meaningful symptom relief.
For physicians, this clearance may simplify institutional adoption and value analysis review, while aligning device labeling, clinical evidence, and CPT coding pathways for thyroid RFA.
The milestone caps a 24-year journey that began in June 2002, when Dr. Jung Hwan Baek performed the world's first thyroid RFA procedure in South Korea using STARMED equipment. In the decades that followed, STARMED devices became the platform behind the field, cited in over 300 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," said Henry Shin, CEO of STARMED Co., Ltd. " This clearance reflects the trust physicians and researchers around the world have placed in our technology for more than two decades."
About STARMED America
STARMED America is the U.S. subsidiary of STARMED Co., Ltd., a global leader in radiofrequency ablation technology.
For more information please visit, www.starmed.com
