# STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication

- Link: https://www.thailand-business-news.com/pr-news/starmed-receives-fda-510k-clearance-for-a-benign-thyroid-nodule-ablation-indication
- Published: 2026-07-01T19:00:00+07:00
- Author: PR Newswire

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SEOUL, South Korea, July 1, 2026 /PRNewswire/ — STARMED, a medical device company
specialising in minimally invasive treatment technologies, has announced that it
has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for
a thyroid-specific indication (510(k) number: K252833). The clearance took effect
on 26 May 2026. The company’s system may now be used for ultrasound-guided percutaneous
ablation of eligible, cytologically confirmed benign thyroid nodules in adults.

STARMED is the first and only company in the world to have obtained an FDA clearance
for an indication specific to thyroid nodule ablation.

"This clearance represents an important milestone for physicians and healthcare 
institutions evaluating thyroid radiofrequency ablation," said Henry Shin, CEO of
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."

The specificity of the labelling clearly distinguishes the clearance from a general
soft-tissue ablation indication. The clearance directly names thyroid nodules, ultrasound
guidance, the percutaneous approach, the adult patient population, and the applicable
clinical eligibility criteria.

The cleared STAR RF Electrode is a radiofrequency ablation electrode engineered 
to support precision in ultrasound-guided percutaneous ablation of eligible benign
thyroid nodules in adults. The VIVA RF Electrode, also covered by the clearance,
is a monopolar electrode with an adjustable active tip that allows clinicians to
adjust the ablation size according to clinical need.

STARMED developed the world’s first³ thyroid-dedicated RFA electrode in 2009 and
has continued to collaborate with clinicians and academic centres to support technology
development, procedural education, and technique refinement. The company currently
supports thyroid RFA training centres in more than ten countries, and its thyroid
technologies are referenced in more than 300⁵ peer-reviewed clinical publications.

Further information on the FDA-cleared thyroid nodule indication is available at
[https://starmed-america.com/thyroid-nodule-rfa-fda-indication/](https://starmed-america.com/thyroid-nodule-rfa-fda-indication/).

**About STARMED**

Founded in 2009, STARMED develops world-class thermal ablation technologies for 
minimally invasive treatment across thyroid, liver, kidney, uterine, pancreatic,
and other clinical applications. The company’s technologies are supported by more
than 700 sources of clinical research evidence and are available in more than 70
countries. Through continued product development, collaboration with physicians 
and academic centres, and structured clinical education, STARMED works to expand
access to precise, minimally invasive thermal ablation therapies.

 

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