Summary: Thyroid radiofrequency ablation (RFA) is a minimally invasive, FDA-cleared treatment for benign thyroid nodules. It offers an alternative to surgery with proven safety and efficacy. The American Thyroid Association (ATA) provides guidelines for training and patient care.
- Thyroid RFA is FDA cleared, not FDA approved.
- Proven safety: Clinical studies show effective nodule reduction with minimal risks.
- FDA clearance means it meets safety/performance standards.
- ATA and AACE guidelines ensure practitioner competency and patient safety.
- New CPT codes (60660 & 60661) in 2025 will support insurance reimbursement.
- Malignant nodule treatment is still under investigation.
- STARmed America leads RFA research and supports clinician adoption.
When patients first hear about thyroid radiofrequency ablation (RFA), it almost sounds too good to be true. It’s a minimally invasive, in-office treatment option that preserves healthy thyroid tissue. Often, RFA eliminates the need for lifetime medications and reduces cosmetic concerns, all without anesthesia.
Naturally, clinicians want to ensure an emerging procedure is safe before offering it to their patients. One of the most common questions we hear is: “Is Thyroid RFA FDA approved?”
While RFA does not require FDA approval, we’re proud to share that it is an FDA cleared procedure.
In 2018, the U.S. FDA cleared STARmed RF Equipment for the treatment of soft tissue. As a result, patients now have access to a minimally invasive alternative to surgery. Likewise, clinicians can offer patients a safe and efficacious treatment that is both time- and cost-effective.
What does it mean to be FDA cleared, and what does it say about the safety profile of the RFA procedure for thyroid? Read on to learn about this non-surgical option to address symptomatic or cosmetically concerning nodules.
Is RFA a Safe Procedure?
Radiofrequency ablation has a well-established safety profile. A host of clinical studies have demonstrated that RFA effectively reduces thyroid nodule volume with minimal complications. The most common side effects are typically mild and transient.
Patients report that the procedure is well-tolerated. In fact, it has provided a solution for many older patients with symptomatic nodules. Those individuals would not otherwise be strong surgical candidates. The use of local vs general anesthesia makes it a safer option for many patients who cannot tolerate full sedation.
Thyroid RFA has been FDA cleared for treating benign thyroid nodules. That means it was evaluated based on its similarity to other approved RFA treatments. This serves as proof that RFA is a safe, regulated procedure under FDA guidelines.
What Does It Mean to Be FDA Cleared?
FDA clearance is necessary for medical procedures that require the use of new technology. Radiofrequency ablation has received FDA clearance because there is enough clinical evidence to prove the following:
- Thyroid RFA is effective for its intended purpose (treatment of benign thyroid nodules).
- The benefits of the Thyroid RFA procedure outweigh the risks.
- The RFA procedure meets strict safety and performance standards.
FDA approval differs from FDA clearance. FDA approval means a treatment has been rigorously tested through clinical trials and is proven safe and effective. In contrast, clearance is reserved for a treatment that is equivalent to an existing FDA-approved treatment.
Radiofrequency Ablation: FDA Guidelines
Following FDA clearance, professional medical associations tend to develop detailed treatment guidelines. In the case of RFA for thyroid, this guidance comes from the American Thyroid Association (ATA).
In 2023, the ATA put out “General Principles for the Safe Performance, Training, and Adoption of Ablation Techniques for Benign Thyroid Nodules.” This document offers the best practices for RFA practitioners.
The ATA’s statement includes:
- Guidelines for practitioner training and competency, including proctored experience and continuous monitoring.
- Guidelines for patient selection and pre-procedure management, including nodule characteristics and indications for ablation.
- Peri-procedural considerations, including procedure technique and complication management.
- Post-procedure management guidelines, including monitoring instructions and follow-up care.
The role of these guidelines is to standardize the practice of radiofrequency ablation for the thyroid. They ensure optimal patient outcomes at every stage, from clinician training through post-procedure care.
The American Association of Clinical Endocrinology (AACE) published a similar consensus statement in 2022. Like the ATA statement, this statement provides guidance on indications, techniques, potential complications, and follow-up care related to RFA treatments. Its application in malignant thyroid nodules is still under investigation. Ongoing research and subsequent regulatory evaluations will determine whether RFA becomes an approved treatment for malignant indications in the future.
Is All Thyroid Radiofrequency Ablation FDA Approved?
At present, STARmed VIVA combo RF System, star and VIVA II RF Electrodes are FDA Cleared for the ablation of soft tissue. Each medical device company must independently submit an FDA clearance application, demonstrating the safety of their equipment for human use within its specified indication. Its safety profile should be comparable to, or superior to, existing technologies.
Not all companies have received FDA clearance for their RFA equipment. STARmed’s FDA clearance is a testament to its safety, reliability, and clinical effectiveness, as supported by over 200 published clinical articles.
Insurance Coverage and Standardized Billing for Thyroid RFA
Effective January 1st, 2025, the American Medical Association (AMA) has introduced new Current Procedural Terminology (CPT) codes specific to thyroid RFA.
Those codes are:
- CPT Code 60660. Used for the ablation of one or more thyroid nodules in a single lobe or the isthmus, including imaging guidance.
- CPT Code 60661. An add-on code used to cover ablation of nodules in an additional lobe.
The existence of these codes will improve insurance coverage and streamline the billing process for thyroid RFA procedures. The establishment of these CPT codes also further establishes the safety and efficacy of the RFA procedure for thyroid.
Why? The approval of dedicated CPT codes follows a rigorous review by medical organizations. The AMA only assigns specific CPT codes to procedures that have demonstrated clinical validity and widespread acceptance. Thus, the existence of these new codes reflects that the thyroid RFA procedure is no longer considered experimental or investigational.
Ultimately, the addition of CPT codes indicates increasing adoption of thyroid RFA by interventional radiologists, endocrine surgeons, endocrinologists, and otolaryngologists.
Step into the Future of Thyroid RFA with STARmed America
STARmed America supports the generation of high-quality clinical evidence through collaborative research initiatives. To date, more than 200 articles have been published with STARmed technology. We’re proud that our technology has played a role in achieving FDA clearance for this safe, life-changing procedure.
Are you interested in implementing thyroid RFA in your clinical practice? Learn more about Thyroid RFA and discover how STARmed America can help.
