NeuroOne’s Innovative OneRF Device Receives FDA Clearance, Paving Way for Advanced Neurosurgical Procedures

The US Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroOne for its radiofrequency ablation system, OneRF. The approval allows neurosurgeons to utilize the OneRF device in functional neurosurgical procedures, catering to both diagnostic and therapeutic functions. The device enables the ablation of nervous tissue while simultaneously recording electrical activity in the brain. 

NeuroOne's thin-film electrodes, designed for recording electrical activity in the brain for less than 30 days, provide a unique diagnostic and therapeutic combination for treating patients with neurological conditions such as epilepsy, brain tumors, chronic back pain, and Parkinson's disease. NeuroOne CEO Dave Rosa expressed optimism about transforming the approach to these surgeries, potentially reducing the need for separate diagnostic and therapeutic procedures.

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NeuroOne's CEO, Dave Rosa, expressed the company's ambitious goal to develop and commercialize thin-film electrodes with dual capabilities, performing both diagnostic and therapeutic functions. This innovative methodology aims to enhance the treatment of patients suffering from various neurological conditions. 

In October 2022, the FDA approved NeuroOne's Evo cortical and stereoelectroencephalography (SEEG) electrodes. This makes the company even stronger in its ability to track, record, and stimulate electrical signals in the brain's subsurface. The brain ablation market, estimated to be worth at least $100 million globally, has witnessed significant developments. Boston Scientific's acquisition of Relievant Medsystems for $850 million in September 2023 marked a notable move in the ablation treatment space. 

Additionally, Relievant Medsystems had pioneered a nerve ablation system for treating a type of chronic back pain. The expansion of ablation treatments extends beyond neurological applications to cardiovascular procedures. In November of the same year, 2023, Medtronic received a CE mark for its pulsed field ablation system, reflecting the broader applications and growing market for ablation technologies. As NeuroOne prepares to roll out its OneRF device in the first half of 2024, the FDA clearance positions the company to contribute to the evolution of neurosurgical procedures. With a focus on both diagnostic and therapeutic functionalities, the OneRF system presents a unique and promising advancement in the treatment of neurological conditions. NeuroOne's commitment to minimally invasive electrodes manufactured with polyimide thin film aligns with the industry's shift towards innovative and patient-centric solutions. 

The company anticipates significant changes in the approach to neurosurgical procedures, aiming for a future where patients may only need a single surgery for both diagnostic and therapeutic purposes. The convergence of technology, medical innovation, and a growing market for ablation treatments underscores the dynamic landscape of neurosurgery and related therapeutic interventions.