NeuroOne Medical Seeking Special Use for Evo sEEG Electrode

NeuroOne Medical Technologies Corporation has submitted a special 510(k) application to the U.S. Food and Drug Administration (FDA) for its sEEG electrode. The company wants to extend the electrode’s use from less than 24 hours to less than 30 days.

A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).
 
“Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline,” CEO Dave Rosa stated. “We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion.”
 
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs.