IR Update: FDA Clears Ultrasound-Guided Ablation of Benign Thyroid Nodules in Adults

The Food and Drug Administration (FDA) has granted the Star RF Electrode and Viva RF Electrode devices a 510(k) clearance for ultrasound-guided percutaneous ablation of benign thyroid nodules in adults.

Use of the Star RF Electrode for radiofrequency ablation facilitates enhanced precision with ablation of benign thyroid nodules, according to Starmed, the manufacturer of both modalities. The company noted that the monopolar Viva RF Electrode allows interventional radiologists to adjust the ablation size as necessary.

Starmed said the FDA clearance for the Star RF Electrode and Viva RF Electrode is the first to cover thyroid nodule ablation and covers benign thyroid nodules that are symptomatic or cosmetically concerning to patients. The devices may also be employed to address benign thyroid nodule volume less than 10 mL, which indicates autonomously functioning nodules, according to Starmed.

“This clearance represents an important milestone for physicians and healthcare institutions evaluating thyroid radiofrequency ablation," said Henry Shin, the CEO at Starmed. “By specifically identifying the procedure, anatomy, patient population, and clinical criteria, the indication provides clear regulatory alignment for the use of our system in eligible benign thyroid nodules. It also reflects more than two decades of thyroid-focused technology development and physician collaboration.”