Brief: NeuroOne Provides Evo sEEG Update

Neuroone Medical Technologies

16/05/2022 21:49

May 16 (Reuters) - Neuroone Medical Technologies Corp
 NMTC.O :
    * NEUROONE MEDICAL TECHNOLOGIES CORP - FDA COMPLETED REVIEW
OF
APPEAL FOR 510(K) CLEARANCE FOR EVO SEEG ELECTRODE FOR LESS THAN
30-DAY USE
    * NEUROONE MEDICAL TECHNOLOGIES CORP - FDA STATED THAT THEY
WERE
UPHOLDING THEIR DECISION THAT DEVICE IS NOT SUBSTANTIALLY
EQUIVALENT FOR EXTENDED USE
    * NEUROONE MEDICAL TECHNOLOGIES - FDA STATED CO MAY SUBMIT A
NEW
510(K) WITH NEW EVIDENCE TO SUPPORT A FINDING OF SUBSTANTIAL
EQUIVALENCE
    * NEUROONE MEDICAL TECHNOLOGIES CORP - INTENDS TO SUBMIT A
SPECIAL
510(K) WHICH ACCORDING TO FDA GUIDANCE IS PROCESSED WITHIN 30
DAYS OF RECEIPT
    * NEUROONE MEDICAL TECHNOLOGIES CORP - EXPECTS TO RESUBMIT
APPLICATION TO FDA IN AUGUST 2022

Source text for Eikon:  ID:nPn833Jgta 
Further company coverage:  NMTC.O 

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