NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.
Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance 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, according to a news release.
The Evo sEEG electrode represents the second FDA-cleared product from NeuroOne its Evo cortical electrode technology in November 2019. The company develops surgical care options for patients suffering from neurological disorders.
NeuroOne’s sEEG electrodes, contrary to cortical electrodes, provide a similar function at the subsurface level of the brain while using a much less invasive process as it does not require the removal of the top portion of the patient’s skull.
The company anticipates a launch of the Evo sEEG by the end of calendar year 2021, pending additional regulatory clearance for labeling that would enable longer-term use.
“This represents yet another critical milestone met by the Company as we continue to execute our strategy,” NeuroOne CEO Dave Rosa said in the release. “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’s disease and chronic back pain.”