FDA Clears sEEG Electrode Technology for Short-Term Use 

The Food and Drug Administration (FDA) 510(k) granted clearance to market a subsurface EEG (sEEG) electrode (Evo sEEG electrode; NeuroOne, Eden Prairie, MN) for short-term (less than 24 hours) use with for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

"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 labeling for longer term use, which we believe will be a key part of our commercialization 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 disease and chronic back pain," said Dave Rosa, chief executive officer of NeuroOne.

The sEEG electrodes provide a similar function to cortical electrodes at the subsurface level of the brain by using a less invasive process without the required removal of the top portion of an individual's skull. Potential advantages of the sEEG electrodes are increased signal clarity and reduced noise, better tactile feedback during insertion into brain tissue, and faster order fulfillment due to an automated manufacturing process.