NeuroOne Medical Technologies Corp

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Neuroone Medical FDA Had Denied Co's 510(K) Clearance Application For Use Of Evo Seeg Electrode Technology

Published: 03/25/2022 21:01 GMT
NeuroOne Medical Technologies Corp (NMTC) - Neuroone Medical - on Mar 11, Co Received Letter That FDA Had Denied Co’s 510(k) Clearance Application for Use of Evo Seeg Electrode Technology.
Neuroone - FDA Letter Stated Co Has Not Demonstrated That Seeg Electrode for Less Than 30-day Use is Substantially Equivalent to Predicate Device.
Neuroone - FDA Also Stated, Co May Re-submit New 510(k) If It Has Biocompatibility Data It Believes Can Show Its Device to Be Substantially Equivalent.
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