StarMed Earns FDA Nod for RF Ablation of Thyroid Nodules

StarMed has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its platform that delivers radiofrequency (RF) ablation for thyroid nodules.

The company said it’s the first to achieve FDA clearance for RF ablation of thyroid nodules.

The VIVA combo RF generator, star RF electrodes, and VIVA RF electrodes are 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 FDA nod was supported by a systematic literature review of 42 peer-reviewed publications, each showing volume reduction ratio (VRR) of ≥ 50% at six months, which is the clinical benchmark for meaningful symptom relief.

This milestone concludes a 24-year trip that began when Dr. Jung Hwan Baek performed the world’s first thyroid RFA procedure in South Korea using StarMed equipment. In the ensuing decades, StarMed devices became the platform behind the field and is cited in more than 300 publications.

“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. “This clearance reflects the trust physicians and researchers around the world have placed in our technology for more than two decades.”