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July 2, 2026
StarMed America Receives FDA Clearance for RFA Devices to Treat Thyroid Nodules
KEY TAKEAWAYS
- FDA clears StarMed radiofrequency ablation devices: Viva Combo RF generator, Star RF electrodes, and Viva RF electrodess.
- The devices are indicated for symptomatic, cosmetically concerning, and certain autonomously functioning benign thyroid nodules treated under ultrasound guidance.
- Clearance was supported by a systematic literature review demonstrating a volume reduction ratio of ≥ 50% at 6 months.
July 2, 2026—StarMed America announced FDA 510(k) clearance for its radiofrequency ablation (RFA) devices for the treatment of thyroid nodules.
According to StarMed, the cleared devices are the Viva Combo RF generator, Star RF electrodes, and Viva RF electrodes. The devices 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 < 10 mL.
The company’s press release noted that FDA clearance was supported by a systematic literature review of 42 peer-reviewed publications, each demonstrating a volume reduction ratio of ≥ 50% at 6 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, stated StarMed America.
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