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

Neuroone Medical Technologies

25/03/2022 20:59

March 25 (Reuters) - Neuroone Medical Technologies Corp
 NMTC.O :
    * 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

Further company coverage:  NMTC.O 

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