NeuroOne Medical Technologies has filed a 510(k) application with the US Food and Drug Administration (FDA) for its first therapeutic device OneRFAblation System.
OneRF utilises the already implanted sEEG electrodes for recording brain activity and ablating nervous tissue when linked to a radio frequency (RF) generator.
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It is a combination system that comprises both diagnostic and therapeutic capabilities.
It deploys a customised RF generator with real-time temperature monitoring capabilities to help clinicians better control temperature during ablation.
According to the company, the system is designed to lower the number of invasive procedures and hospital stays for patients.
NeuroOne CEO Dave Rosa said: “This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF probe to ablate nervous tissue.
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By GlobalData“In addition, it marks the company’s first complete system combining hardware, software and our novel electrode technology.
“Over the past few years, we have been excited with the feedback we have received from our advisory board as well as the performance of the system in animal feasibility studies.”
NeuroOne expects to receive initial feedback from the FDA by 7 August this year.
Last month, NeuroOne announced the first robotic neurosurgery case using its Evo sEEG electrode. The procedure was carried out by Dr William Bingaman at Cleveland Clinic.
