Charles Sternberg, Associate Editor08.09.22
NeuroOne Medical Technologies Corporation, a company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has submitted a special 510(k) to the U.S. Food and Drug Administration (FDA) for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use.
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).
Dave Rosa, chief executive officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. 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."
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).
Dave Rosa, chief executive officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. 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."