• NEW FDA-CLEARED INDICATION
The STARMED VIVA combo RF System is the only device with an FDA-cleared indication specifically written for ultrasound-guided percutaneous ablation of benign thyroid nodules in adults.
STARMED’s VIVA combo RF System is the first device to receive an FDA clearance with an indication specific to radiofrequency ablation of benign thyroid nodules in the United States (510(k) K252833), distinguishing it from general soft-tissue RFA clearances.
FDA-Cleared Indication
Indications for Use
"The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. The VIVA combo RF generator, star RF Electrodes, and VIVA RF Electrodes are indicated for ultrasound-guided percutaneous ablation of cytologically-confirmed benign thyroid nodules in adults that are symptomatic, cosmetically concerning, and/or autonomously functioning. Autonomously functioning nodules are indicated if nodule volume is < 10 mL."
CLINICAL & OPERATIONAL IMPACT
When hospitals evaluate new technologies, regulatory status matters. A procedure-specific indication can help support value analysis review, physician privileging discussions, and program development activities.
Your patients seeking a non-surgical treatment option now have access to a device specifically cleared for thyroid nodule ablation. The indication was written for this anatomy, this patient population, and these clinical criteria.
"When the medical community adopts a specific indication for use as routine practice, manufacturers and physicians want that specific indication for use to appear on the labeling for both liability and reimbursement purposes."
Clinical Evidence
PEER-REVIEWED
PUBLICATIONS
ON THE STARMED DEVICE
VOLUME REDUCTION
AT 6 MONTHS
ACROSS ALL STUDIES
The 510(k) K252833 clearance was supported by a systematic review of 42 device-specific publications — including prospective and retrospective cohort studies, randomized trials, and case series — in which a VRR ≥50% at 6 months was consistently reported regardless of geographic location, nodule composition, or operator experience. A state-of-the-art review of 31 additional publications confirmed that RFA demonstrates similar effectiveness and a lower complication rate compared to surgery.
This is not a question of which RFA device performs best in a head-to-head trial. It is a question of regulatory standing — and the clinical evidence that earned it.
| STARMED VIVA combo RF System | All Other US-Cleared RFA Devices | |
|---|---|---|
| FDA Clearance Type | Procedure-specific: thyroid nodule ablation | General soft tissue ablation |
| Thyroid Nodules Named in Indication | Yes — explicit, verbatim | No — inferred from broad label |
| Patient Eligibility Criteria in Label | Yes — symptomatic, cosmetic, autonomously functioning, volume < 10 mL for AFTNs | Not specified |
| Ultrasound Guidance Specified | Yes — ultrasound-guided, percutaneous | Not specified |
| CPT 60660 / 60661 Alignment | Direct — indication matches the billed procedure | Indirect — soft tissue label requires physician attestation |
| VAC Documentation Support | Procedure-specific indication for committee review | Off-label or broadly interpreted clearance |
| Years of Thyroid RFA Experience | 24 years — pioneered the procedure in 2002 | Varies — most entered market significantly later |
Connect with STARMED America
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STARmed Co., Ltd. 510(k) Summary K252833: VIVA combo RF System. U.S. Food & Drug Administration, Center for Devices and Radiological Health. Prepared May 18, 2026; cleared May 26, 2026. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
American Medical Association. CPT Category I code 60660 (Ablation, Thyroid(s), Percutaneous, Including Ultrasound Guidance, Unilateral) and add-on code 60661 — effective January 1, 2025.
U.S. Food & Drug Administration. General/Specific Intended Use — Guidance for Industry. Center for Devices and Radiological Health, Office of Device Evaluation. November 4, 1998. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry. PDF: https://www.fda.gov/media/71966/download
Procedure coding should be based upon medical necessity, procedures, and supplies provided to the patient. Coding and reimbursement information is provided for educational purposes and does not assure coverage of the specific item or service in a given case. STARMED America makes no guarantee of coverage or reimbursement of fees. These payment rates provided are nationally unadjusted average amounts and do not account for differences in payment due to geographic variation. Contact your local Medicare Administrative Contractor (MAC) or CMS for specific information as payment rates listed are subject to change. To the extent that you submit cost information to Medicare, Medicaid, or any other reimbursement program to support claims for services or items, you are obligated to accurately report the actual price paid for such items, including any subsequent adjustments.
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