NeuroOne Receives FDA Approval for OneRF™ Ablation System

NeuroOne Medical Technologies has received U.S. FDA 510(k) clearance of OneRF™ Ablation System for creation of radiofrequency (RF) lesions in nervous tissue for functional neurosurgical procedures.

The OneRF Ablation System is NeuroOne’s first device with a therapeutic indication and its third FDA 510(k)-cleared device, boasting a full line of electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode.

NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.

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.