Brief: Pulse Biosciences Provides Update On Recent FDA 510(k) Submission

Pulse Biosciences

08/02/2022 14:27

Feb 8 (Reuters) - Pulse Biosciences Inc  PLSE.O :
    * PULSE BIOSCIENCES PROVIDES AN UPDATE ON RECENT FDA 510(K)
SUBMISSION
    * PULSE BIOSCIENCES INC - ON FEBRUARY 5, CO RECEIVED AN
ADDITIONAL
INFORMATION LETTER FROM FDA IN RESPONSE TO 510(K) SUBMITTED
    * PULSE BIOSCIENCES - IN AI LETTER, FDA STATED IT DID NOT
BELIEVE
COMPANY PROVIDED SUFFICIENT CLINICAL EVIDENCE TO SUPPORT
EXPANDED INDICATION FOR USE
    * PULSE BIOSCIENCES INC - BASED ON FDA GUIDANCE, COMPANY
BELIEVES
ITS MEETING WITH FDA WILL TAKE PLACE IN Q1 2022
    * PULSE BIOSCIENCES - SEES MEETING WITH FDA TO DISCUSS
CONTENTS OF
AI LETTER AND POTENTIAL NEXT STEPS
    * PULSE BIOSCIENCES INC - BASED ON FDA GUIDANCE, COMPANY
BELIEVES
ITS MEETING WITH FDA WILL TAKE PLACE IN Q1 2022

Source text for Eikon:  ID:nBwbvgWqFa 
Further company coverage:  PLSE.O 

 ((Reuters.Briefs@thomsonreuters.com;))