Thursday, August 11, 2022
NeuroOne Medical Technologies Corporation, a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company submitted a special 510(k) to the U.S. Food and Drug Administration ("FDA") on August 8th 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."
On May 16th, the Company issued a press release stating the FDA's decision to uphold the not substantially equivalent decision after the Company had appealed the ruling. The FDA also informed the Company it could submit a new 510(k) with new evidence specifically as it relates to the subacute toxicity biocompatibility endpoint.