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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears STARMED's RF Ablation System for Benign Thyroid Nodules

The 510(k) adds a thyroid-specific indication to the Korean company's existing soft-tissue ablation system, supported by a literature review rather than a new clinical trial.

By News DeskJuly 2, 20262 min read
Illustration of the thyroid gland and parathyroid glands in the neck
A medical illustration of the thyroid and parathyroid glands. Not related to the STARMED system described in this article. US federal government, Public domain, via Wikimedia Commons · Public domain (work of the US federal government)
FDA cleared510(k) · K252833FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared STARMED's VIVA combo RF System for ultrasound-guided ablation of benign thyroid nodules under 510(k) K252833 on May 26, 2026; the company announced it on July 1.
  • The indication covers cytologically confirmed benign nodules in adults that are symptomatic, cosmetically concerning or autonomously functioning, the last only if under 10 mL.
  • No new clinical study was required; the 510(k) summary cites a systematic review in which all 42 publications on the device reported nodule volume reductions of at least 50% at six months.

STARMED, a South Korean maker of thermal ablation devices, said the US Food and Drug Administration has cleared its radiofrequency ablation system for treating benign thyroid nodules, in a July 1 release distributed by PR Newswire. The company said it is the first and only company in the world to have obtained FDA clearance for an indication specific to thyroid nodule ablation, a claim Health Sense has not independently verified.

According to the FDA clearance letter and 510(k) summary, the clearance, K252833, is dated May 26, 2026. It covers the VIVA combo RF generator, star RF Electrodes and VIVA RF Electrodes, with the company's earlier generator and electrode clearances, K234140 and K203795, as predicates.

What the clearance covers

The system was already intended for percutaneous and intraoperative coagulation and ablation of tissue. The new indication is 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 covered if their volume is under 10 mL. The summary states there are no changes to the device technology, only to the indications for use.

The generator can deliver up to 200 watts and monitors impedance, current, power and temperature, adjusting output as impedance rises. For thyroid use, the summary limits the configuration to monopolar mode with 18 to 19 gauge electrodes, 4 to 15 millimeter exposed tips and power settings of 5 to 80 watts. It also describes a more specific user profile, citing American Thyroid Association recommendations on practitioner training in thyroid diagnosis, neck imaging and ultrasound-guided biopsy.

A literature review instead of a trial

"No clinical studies were necessary to establish substantial equivalence," the summary states. STARMED instead submitted a systematic literature review. A state-of-the-art portion covering 31 publications, including society guidelines and meta-analyses, found that radiofrequency ablation has similar effectiveness and a lower rate of complications than surgery, according to the summary. The device-specific portion covered 42 publications describing use of the system in 20 or more patients; all reported a volume reduction ratio of at least 50% at six months, and adverse event types and rates were consistent with the benchmarks.

StarMed America said the clearance may simplify institutional adoption and value analysis review and aligns device labeling, clinical evidence and billing codes for thyroid ablation, Endovascular Today reported on July 2.

"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," chief executive Henry Shin said in the release. STARMED, founded in 2009, said it developed its first thyroid-dedicated ablation electrode that year and that its technologies are available in more than 70 countries.

Sources

  1. STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication (PR Newswire), STARMED, July 1, 2026
  2. K252833 clearance letter and 510(k) summary: VIVA combo RF System, US Food and Drug Administration, May 26, 2026
  3. StarMed America Receives FDA Clearance for RFA Devices to Treat Thyroid Nodules, Endovascular Today, July 2, 2026