LOS ANGELES, Calif., June 30, 2026
STARMED America has achieved a historic milestone in thyroid disease treatment after receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for the first radiofrequency ablation (RFA) system specifically indicated for the treatment of benign thyroid nodules in the United States. The approval establishes STARMED as the first and currently only company with an FDA-cleared indication for thyroid nodule radiofrequency ablation, expanding access to a minimally invasive alternative to surgery for millions of patients. The clearance covers the VIVA combo RF Generator, star RF Electrodes, and VIVA RF Electrodes, enabling physicians to perform ultrasound-guided percutaneous ablation of cytologically confirmed benign thyroid nodules. The milestone reflects more than two decades of clinical innovation and positions STARMED at the forefront of image-guided thermal ablation technologies, providing healthcare providers with a new option that preserves thyroid function while reducing the need for conventional surgical intervention.
FDA Clearance Introduces a New Standard for Thyroid Nodule Treatment
The FDA 510(k) clearance authorizes the use of STARMED’s radiofrequency ablation system for adults with symptomatic, cosmetically concerning, or autonomously functioning benign thyroid nodules. The indication applies to ultrasound-guided percutaneous ablation, allowing physicians to treat patients through a minimally invasive outpatient procedure rather than traditional thyroid surgery. Autonomously functioning thyroid nodules with a volume below 10 mL are also included within the approved indication.
The regulatory decision was supported by a comprehensive systematic review of 42 peer-reviewed clinical studies, all demonstrating a volume reduction ratio (VRR) of at least 50% after six months, the accepted benchmark for meaningful symptom improvement. By aligning FDA-cleared labeling with established clinical evidence and existing reimbursement pathways, the approval is expected to simplify institutional adoption while encouraging broader integration of thyroid RFA into routine endocrine practice across the United States.
Clinical Evidence Supports Minimally Invasive Innovation
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Thyroid nodules affect an estimated 65% of the U.S. population, although only a portion require treatment because of symptoms, cosmetic concerns, or excessive hormone production. Until now, patients typically faced a choice between long-term monitoring or surgical removal of part or all of the thyroid gland. Radiofrequency ablation provides an effective minimally invasive alternative that preserves healthy thyroid tissue while avoiding surgical scars, hospitalization, and prolonged recovery.
STARMED’s technology has become one of the world’s most extensively studied thyroid RFA platforms, supported by more than 300 published clinical studies demonstrating its safety and effectiveness. The company’s devices have played a central role in the global evolution of thyroid ablation, helping establish RFA as an evidence-based treatment option for benign thyroid disease while improving patient outcomes through less invasive care.
Twenty-Four Years of Innovation Drive Global Leadership
The FDA clearance represents the culmination of 24 years of technological development that began in June 2002, when the world’s first thyroid radiofrequency ablation procedure was successfully performed in South Korea using STARMED equipment. Since that landmark procedure, the company’s radiofrequency ablation systems have become widely adopted by physicians and researchers worldwide, contributing to the growing body of clinical evidence supporting thyroid RFA.
Company leadership believes the FDA authorization validates decades of scientific research, engineering innovation, and physician collaboration while opening a new chapter for minimally invasive endocrine therapy in the United States. As healthcare providers increasingly seek alternatives that reduce procedural risk while maintaining excellent clinical outcomes, STARMED’s FDA-cleared thyroid RFA platform is positioned to transform the management of benign thyroid nodules and further strengthen the company’s leadership in interventional medical technology.
Source: STARMED America press release
