NeuroOne secures FDA clearance for OneRF ablation system

The US Meals and Drug Administration (FDA) has cleared NeuroOne’s radiofrequency ablation system, with a rollout of the system anticipated by the corporate within the first half of 2024.

The 510(okay) clearance means the OneRF system can now be utilized by neurosurgeons on sufferers needing lesions of nervous tissue for purposeful neurosurgical procedures.

The system can ablate nervous tissue and report electrical exercise within the mind. In line with US-based NeuroOne, it has acquired the primary clearance for a diagnostic and therapeutic mixture system for each recording electrical mind exercise and eradicating goal areas of mind tissue to deal with sufferers dwelling with neurological circumstances corresponding to epilepsy, mind tumours, continual again ache, and Parkinson’s illness.

NeuroOne CEO Dave Rosa mentioned: “One in every of our formidable objectives was to be the primary to develop and commercialise thin-film electrodes able to performing each diagnostic and therapeutic capabilities and supply a greater methodology to deal with sufferers affected by a wide range of neurological circumstances.”

NeuroOne’s minimally invasive electrodes are manufactured utilizing polyimide skinny movie. They’re designed to report electrical exercise within the mind for lower than 30 days.

Rosa added: “We consider now we have the potential to dramatically change the best way these surgical procedures are carried out in order that sufferers might solely must undergo surgical procedure as soon as for each diagnostic and therapeutic procedures.”

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The corporate’s Evo cortical and stereoelectroencephalography (SEEG) electrodes have been cleared by the FDA for monitoring, recording, and stimulating electrical alerts on the subsurface degree of the mind in October 2022.

NeuroOne estimates the mind ablation market is price no less than $100m globally. September 2023 noticed a giant transfer within the ablation remedy area when Boston Scientific acquired Relievant Medsystems for $850m. Relievant Medsystems had developed and commercialised a nerve ablation system for the remedy of a sort of continual again ache.

The market is rising quickly alongside cardiovascular purposes of ablation, the place the remedy can be generally used. In November this yr, Medtronic secured a CE mark for its pulsed discipline ablation system.


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