Brief: SHL Telemedicine Files Pre-Submission With FDA For Over The Counter Clearance Of Smartheart Full 12 Lead ECG

SHL Telemedicine

12/01/2021 06:03

Jan 12 (Reuters) - SHL Telemedicine Ltd  SHLTN.S :
    * SHL TELEMEDICINE FILES PRE-SUBMISSION WITH FDA FOR OVER
THE
COUNTER CLEARANCE OF SHL’S SMARTHEART™ FULL 12 LEAD ECG
    * FILES PRE-SUBMISSION WITH FDA FOR OVER COUNTER CLEARANCE
OF
SHL'S SMARTHEART™ FULL 12 LEAD ECG
    * FDA'S PRE-SUBMISSION PROGRAM (PRE-SUB) ALLOWS MEDICAL
DEVICE
MANUFACTURERS TO DISCUSS SPECIFIC ASPECTS OF REGULATORY PROCESS
AND REQUIREMENTS WITH FDA.

Source text for Eikon:  ID:nTEN2ekdaa 
Further company coverage:  SHLTN.S 

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