FDA Grants Clearance to OneRF Trigeminal Nerve Ablation System for Facial Pain

The Food and Drug Administration (FDA) has granted 510(k) clearance to the OneRF Trigeminal Nerve Ablation System (NeuroOne Medical Technologies Corporation [NeuroOne], Eden Prairie, MN), authorizing its use for the treatment of pain or for lesioning nerve tissue during neurosurgical procedures through the creation of radiofrequency lesions. According to a statement released by NeuroOne, the company plans to initiate a limited commercial launch of the device in late 2025.

The OneRF Trigeminal Nerve Ablation System is designed as a minimally invasive treatment for people with trigeminal neuralgia, a chronic condition that affects about 150,000 people in the United States annually. The device delivers targeted radiofrequency energy to generate heat that ablates trigeminal nerve fibers, thereby interrupting pain signaling. According to NeuroOne, the OneRF Trigeminal Nerve Ablation System is designed with a multi-contact radiofrequency probe that can both localize and customize the targeted ablation of nerve tissue using a single device. The technology operates under temperature-controlled settings, a feature intended to improve accuracy and safety while also potentially reducing procedure time and enhancing patient comfort.

As previously reported, NeuroOne’s OneRF Ablation System received 510(k) clearance in 2023 for radiofrequency ablation with applications in Parkinson disease (PD), epilepsy, dystonia, essential tremor, and other neurologic conditions.