NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its OneRF? Ablation System for creation of radiofrequency (?RF?) lesions in nervous tissue for functional neurosurgical procedures. The OneRF Ablation System is the Company?s first device with a therapeutic indication and its third FDA 510(k)-cleared device.

NeuroOne now boasts a full line of electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF Ablation System, NeuroOne?s other FDA-cleared devices include the Evo® cortical and sEEG electrode product lines which are used primarily for recording electrical activity in the brain for less than 30 days.