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AUGUST 25, 2025

FDA Grants 510(k) Clearance for Trigeminal Nerve Ablation System to Treat Facial Pain

The FDA granted clearance to market the OneRF Trigeminal Nerve Ablation System (NeuroOne) for use in procedures to create radiofrequency (RF) lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The company targets a limited commercial launch in the fourth quarter of calendar year 2025.

Trigeminal neuralgia is typically treated with medication or invasive procedures, including microvascular decompression, radiosurgery or other percutaneous