Is Thyroid RFA Treatment FDA Approved?

Thyroid nodules are common growths within the thyroid gland, affecting between 20% to 76% of adults. While most are benign, they can cause symptoms or concern, leading individuals to seek treatment. Less invasive alternatives to traditional surgery are gaining interest for managing these nodules. Radiofrequency ablation (RFA) has emerged as a potential option.

Understanding Thyroid Radiofrequency Ablation

Thyroid radiofrequency ablation (RFA) is a minimally invasive procedure that uses heat to reduce the size of thyroid nodules. A thin electrode needle is guided into the nodule, typically under ultrasound imaging. It delivers high-frequency electrical currents, generating localized heat within the nodule.

This heat causes nodule cells to die, leading to gradual shrinkage. RFA aims to alleviate symptoms like difficulty swallowing, neck pressure, or cosmetic concerns from an enlarged nodule. It is used for benign, symptomatic thyroid nodules and autonomously functioning nodules that produce excess hormones.

The FDA and Thyroid RFA

In the United States, the regulatory status of thyroid RFA involves a distinction between device clearance and procedure approval. While the RFA procedure itself is not “FDA approved” like a new drug, the devices used have received FDA clearance. For instance, in 2018, the U.S. FDA cleared certain radiofrequency equipment for the treatment of soft tissue. This clearance indicates the device was evaluated and found substantially equivalent to other legally marketed devices, meeting safety and performance standards.

Device clearance does not mean the FDA formally “approves” every specific procedure for which it might be used. The application of RFA for thyroid nodules often falls under the discretion of the treating physician, guided by accumulating clinical evidence and professional society guidelines. This is considered an “off-label” use, common in medicine when a device is used for an indication other than its originally cleared purpose, supported by scientific data. Recent developments include new CPT codes by the Centers for Medicare & Medicaid Services (CMS) in 2025, intended to streamline insurance coverage for thyroid RFA.

Navigating Treatment Options

Patients with thyroid nodules have several treatment options, depending on the nodule’s characteristics and symptoms. Common established approaches in the U.S. include watchful waiting (monitoring the nodule) or surgical removal (thyroidectomy). Radioactive iodine therapy is another option, particularly for nodules that produce too much thyroid hormone.

Radiofrequency ablation presents a less invasive alternative, and its integration into U.S. practice is growing. RFA is typically performed at specialized centers by practitioners with specific training. While still gaining wider adoption in the U.S., RFA has been a more established and standard treatment in many other countries, particularly in Europe and Asia, for over a decade. Its use in the U.S. is increasingly guided by extensive international clinical evidence and professional society recommendations, such as those from the American Thyroid Association.

What to Discuss With Your Doctor

When considering treatment for a thyroid nodule, a comprehensive discussion with your healthcare provider is essential. It is important to explore all available options tailored to your specific nodule characteristics and overall health. You should inquire about radiofrequency ablation, including its suitability for your case, the availability of the procedure, and your doctor’s experience with RFA.

Shared decision-making with your medical team ensures the chosen treatment aligns with your preferences and health goals. Seeking opinions from specialists like endocrinologists, endocrine surgeons, or interventional radiologists specializing in thyroid care can provide a well-rounded perspective. These specialists can offer insights into RFA’s benefits and considerations within current U.S. practices and regulatory nuances.