NeuroOne® Attains FDA 510(k) Clearance for Novel OneRF™ Ablation System Launch

NeuroOne Medical Technologies Corporation, a leading medical technology company specializing in enhancing surgical solutions for patients with neurological disorders, has announced the FDA's approval of its OneRF™ Ablation System. This system is designed to create radiofrequency ("RF") lesions in nervous tissue, specifically for functional neurosurgical procedures.

The FDA's clearance signifies a significant step forward, offering neurosurgeons a vital tool in managing epilepsy surgically. The OneRF Ablation System allows for ablative therapy using pre-implanted depth electrodes used in stereoEEG for diagnosing the epileptic focus. This advancement aims to improve patient outcomes by potentially reducing interventions and expanding the therapeutic window.

This milestone marks NeuroOne's first device with a therapeutic indication and its third FDA 510(k)-cleared device. With this approval, NeuroOne now offers a comprehensive range of electrode technology catering to both diagnostic brain mapping procedures and RF ablation, utilizing the same sEEG electrode.

Besides the OneRF Ablation System, NeuroOne's existing FDA-cleared devices include the Evo® cortical and sEEG electrode product lines, primarily used for recording brain electrical activity for shorter durations. This expansion highlights NeuroOne's dedication to advancing neurosurgical technology and enhancing patient care in various neurological conditions.


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