NeuroOne Medical Technologies today announced that the first clinical case using the Evo stereoelectroencephalography (sEEG) electrode was recently performed by Robert Gross at Emory University in Atlanta, USA.
Gross selected the Evo sEEG electrode for intraoperative brain mapping at the subsurface level of the brain, a NeuroOne press release states.
“This first clinical case use represents a major milestone achievement of one of our primary objectives for the company,” said NeuroOne CEO Dave Rosa. “We are grateful to Dr Gross and his staff, and were excited to hear of the positive experience he had using the electrode. We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA [Food and Drug Administration] in August for clearance to commercialise the product for less than 30 days use.”
In September 2021, NeuroOne received US FDA 510(k) clearance to market its Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation, of electrical signals at the subsurface level of the brain.