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NeuroOne Submits Special 510(k) To FDA For Evo sEEG Electrode

Author: Benzinga Newsdesk | August 09, 2022 09:01am

NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) ("NeuroOne" or the "Company"), 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).

Posted In: NMTC