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September 8, 2021

NeuroOne secures 510(k) clearance from US FDA for Evo sEEG Electrode

The clearance will enable NeuroOne to market Evo sEEG Electrode for uses of less than 24 hours.

NeuroOne Medical Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Evo sEEG Electrode technology.

Evo sEEG Electrode technology is NeuroOne’s second FDA 510(k) cleared product.

The clearance will enable the company to market the Evo sEEG Electrodes for temporary use with recording, monitoring and stimulation equipment. It can be used for recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

However, unlike cortical electrodes, sEEG electrodes use a much less invasive process and do not require removal of the top portion of the patient’s skull.

Commenting on the 510(k) clearance, NeuroOne CEO Dave Rosa said: “This represents yet another critical milestone met by the company as we continue to execute our strategy.

“The next steps for the company are to expand the sEEG labelling for longer-term use, which we believe will be a key part of our commercialisation strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson’s disease and chronic back pain.”

The company’s portfolio of hi-definition thin film electrodes also includes the Evo Cortical, which received FDA clearance in November 2019.

According to NeuroOne, the potential advantages of the devices are increased signal clarity, better tactile feedback during insertion into brain tissue and faster deliveries due to an automated manufacturing process.

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