South Korea-based StarMed Co., Ltd. has received US Food and Drug Administration (FDA) 510(k) clearance for its radiofrequency ablation (RFA) system for the ultrasound-guided treatment of eligible benign thyroid nodules in adults.

• Regulatory Milestone: The clearance covers the company’s VIVA RF Generator together with the STAR RF Electrode and VIVA RF Electrode for thyroid-specific radiofrequency ablation.
• Clinical Application: The system enables ultrasound-guided percutaneous radiofrequency ablation of cytologically confirmed benign thyroid nodules using controlled thermal energy.
• Commercial Expansion: The FDA clearance enables StarMed to market its thyroid-specific RFA system in the United States.

This summary is based on a news report published by BioSpectrum Asia.

Image for illustrative purposes only. Source: Canva.

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