Home/Pipeline/OneRF® Radiofrequency Ablation System

OneRF® Radiofrequency Ablation System

Nervous Tissue Lesioning (e.g., Epilepsy Foci)

FDA ClearedCommercialK231675

Key Facts

Indication
Nervous Tissue Lesioning (e.g., Epilepsy Foci)
Phase
FDA Cleared
Status
Commercial
Company

About NeuroOne

NeuroOne's mission is to advance neurology through superior thin-film electrode technology, offering improved biocompatibility and signal fidelity over traditional devices. The company has achieved commercial validation with multiple FDA 510(k) clearances for its diagnostic (Evo® sEEG/Cortical) and therapeutic (OneRF® Ablation) systems. Its strategy is to first establish its electrodes as a standard in diagnostic monitoring and then leverage the same platform for therapeutic ablation, creating an integrated solution. This positions NeuroOne to capture value across the epilepsy and neuromodulation markets.

View full company profile