STARMED Receives FDA 510(k) Clearance for a Benign Thyroid Nodule Ablation Indication
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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/.
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.
source: STARMED