NeuroOne Medical Technologies today announced the first clinical case using its Evo sEEG electrodes.
The procedure was performed at Emory University by Dr. Robert Gross for intraoperative brain mapping at the subsurface level of the brain, according to the Eden Prairie, Minnesota-based company.
“This first clinical case use represents a major milestone achievement of one of our primary objectives for the company. We are grateful to Dr. Gross and his staff and were excited to hear of the positive experience he had using the electrode,” NeuroOne CEO Dave Rosa said in a news release. “We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA in August for clearance to commercialize the product for less than 30 days use.”
NeuroOne received FDA 510(k) clearance to market the Evo sEEG electrode technology for temporary use in less than 24 hours for use with recording, monitoring and stimulation equipment, and the stimulation of electrical signals at the subsurface level of the brain.
The company’s EEG recording technology and brain stimulation and ablation solutions are indicated for use in patients with epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.