NeuroOne receives FDA 510(k) clearance for OneRF Ablation System; plans H1 2024 launch

NEUROONE MEDICAL TECHNOLOGIES Corp

FDA 510(k) clearance for OneRF Ablation System to create RF lesions in nervous tissue for functional neurosurgical procedures.
First FDA-cleared thin-film, sEEG-guided RF system combining recording and ablation with temperature control; third FDA-cleared device.
Company targets commercial launch in first half of 2024, either directly or through a strategic partner.
Estimated worldwide brain ablation market at least $100M and growing rapidly, with potential for multifold growth.
Potential for patients to need only one surgery for both diagnostic and therapeutic procedures, reducing hospital stays and adverse events.

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