StarMed America has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company's radiofrequency ablation (RFA) devices for thyroid nodule treatment.
The cleared devices — 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, or autonomously functioning. Autonomously functioning nodules are indicated for treatment if nodule volume is less than 10 mL, according to the vendor.
The clearance was supported by a systematic literature review of 42 peer-reviewed publications, each demonstrating a volume reduction ratio of 50% or greater at six months. The company's devices have been cited in more than 300 publications worldwide and were used in the first thyroid RFA procedure ever performed, conducted in South Korea in June 2002, the firm highlighted.
