Brief: Monogram Orthopaedics Provides Regulatory Update Following Meeting With FDA

Monogram Technologies

01/05/2024 12:43

May 1 (Reuters) - Monogram Orthopaedics Inc  MGRM.O :
    * MONOGRAM ORTHOPAEDICS INC - PROVIDES REGULATORY UPDATE
FOLLOWING
MEETING WITH FDA
    * MONOGRAM ORTHOPAEDICS INC - 510(K) SUBMISSION WITH FDA
ACCELERATED FOR EARLY SECOND HALF OF 2024
    * MONOGRAM ORTHOPAEDICS - PROVIDED UPDATE RELATED TO
REGULATORY,
COMMERCIALIZATION PATH FOR ITS MBÔS SURGICAL SYSTEM FOLLOWING
ITS MEETING WITH FDA
    * MONOGRAM ORTHOPAEDICS INC -  ON APRIL 19, MONOGRAM
RECEIVED
WRITTEN FEEDBACK FROM FDA REGARDING THE COMPANY'S Q1 2023
PRE-SUBMISSION REQUEST
    * MONOGRAM ORTHOPAEDICS - BELIEVES FEEDBACK WAS
COMPREHENSIVE AND
WILL BE ADVANTAGEOUS FOR PREPARING SUCCESSFUL 510(K) SUBMISSION
TO OBTAIN CLEARANCE

Source text for Eikon:  ID:n0001104659-24-055243 
Further company coverage:  MGRM.O 

 (Reuters.Briefs@thomsonreuters.com)