Brief: iRhythm Technologies Receives Warning Letter From FDA

iRhythm Holdings

30/05/2023 21:21

May 30 (Reuters) - iRhythm Technologies Inc  IRTC.O :
    * IRHYTHM TECHNOLOGIES INC - ON MAY 25, CO RECEIVED WARNING
LETTER
FROM FDA WHICH RESULTED FROM INSPECTION OF CO'S FACILITY LOCATED
IN CYPRESS
    * IRHYTHM TECHNOLOGIES- WARNING LETTER ALLEGES
NON-CONFORMITIES TO
REGULATIONS FOR MEDICAL DEVICES, RELATING TO CO'S ZIO AT SYSTEM
    * IRHYTHM TECHNOLOGIES INC -  CO INTENDS TO RESPOND WITHIN
SPECIFIED TIME PERIOD AND WORK DILIGENTLY TO ADDRESS FDA’S
CONCERNS
    * IRHYTHM TECHNOLOGIES INC - WARNING LETTER DOES NOT
DIRECTLY
RESTRICT MANUFACTURE, PRODUCTION OR SHIPMENT OF ANY OF CO'S
PRODUCTS IN U.S.
    * IRHYTHM TECHNOLOGIES INC - WARNING LETTER DOES NOT REQUIRE
THE
WITHDRAWAL OF ANY PRODUCT FROM THE U.S. MARKETPLACE

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