NeuroOne Medical Technologies NMTC 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.
Earlier In May 2022, the regulatory agency has upheld their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.
Now, the company has re-submitted the application for the clearance for less than 30 day use.
Dave Rosa, Chief Executive Officer, stated, "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.”
The Evo sEEG electrode provides a full line of electrode technology for patients requiring diagnostic brain mapping procedures.
In comparison with cortical electrodes, sEEG electrodes provide a similar function at the subsurface level of the brain by using a much less invasive process that does not require removal of the top portion of the patient's skull.
FDA reviews special 510(k) submission within 30 days of receipt, rather than the 90 days for a traditional 510(k).
Price Action : NeuroOne shares are trading around 10 percent down at $1.72 on Tuesday at the time of publication.
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