FDA clears text

NeuroOne’s Brain Stimulation Electrode Cleared

September 9, 2021

NeuroOne Medical has received the FDA’s 510(k) clearance for its Evo sEEG electrode technology for temporary use — for less than 24 hours — for recording, monitoring and stimulation of electrical signals in the brain.

Less invasive than cortical electrodes, the sEEG electrodes provide a similar function but do not require removal of the top portion of the patient's skull.

The company, which plans to seek expanded clearance for longer-term use, is developing permanently implanted stimulation electrodes for patients with chronic conditions, such as epilepsy, Parkinson's disease and chronic back pain.

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