India, April 23 -- NeuroOne Medical Technologies Corp. (NMTC) on Wednesday announced that it has completed its 510(k) submission to the U.S. Food and Drug Administration for its OneRF Trigeminal Nerve Ablation System, a device intended to treat trigeminal neuralgia, a severe and chronic facial pain disorder.
The submission was completed earlier than anticipated, noted the company.
The OneRF Trigeminal Nerve Ablation System features a minimally invasive, temperature-controlled RF procedure that uses a multi-contact probe capable of pain location mapping, stimulation, and ablation-all with a single electrode. This design aims to enhance procedural safety, reduce operative time, and improve overall patient comfort.
"We're excited to expand ...