The FDA clearance will enable NeuroOne to market its Evo sEEG System for temporary use of less than 30 days.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for NeuroOne Medical’s Evo sEEG Electrode technology.
This approval will allow the company to market its Evo sEEG System for temporary use, which is for less than 30 days, with monitoring, recording and stimulation equipment.
The system can be leveraged for monitoring, recording and stimulating the electrical signals at the subsurface level of the brain.
NeuroOne resubmitted its 510(k) application for periods of use of fewer than 30 days on 9 August.
The resubmission included the additional biocompatibility testing that was requested by the regulator.
The company stated that the Evo sEEG Electrode technology is its second FDA 510(k) cleared product.
Now, NeuroOne offers a complete line of electrode technology to address the approximately $100m global market of patients who require diagnostic brain mapping procedures.
Unlike cortical electrodes, sEEG electrodes use a much less invasive process to provide a similar function at the subsurface level of the brain.
In this process, the top portion of the patient’s skull need not be removed.
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NeuroOne CEO Dave Rosa said: “Despite the challenges we faced, our team remained focused and persistent in driving this successful conclusion.
“This is clearly our most exciting and important accomplishment to date. We are now able to advance our commercialisation efforts in partnership with Zimmer Biomet, our distribution and development partner.
“We look forward to continuing to execute our strategic plan, which next up includes our RF ablation system, the company’s first therapeutic electrode technology.”
The company’s portfolio of high-definition thin film electrodes also includes Evo Cortical.
The potential advantages of Evo Cortical and sEEG Electrodes include better tactile feedback during insertion into brain tissue; increased signal clarity; and quick delivery due to an automated manufacturing process.
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