Brief: IRadimed Corporation Withdraws 510(K) With Plans To Resubmit After Further Discussions With FDA

IRADIMED

10/10/2022 13:20

Oct 10 (Reuters) - IRadimed Corp  IRMD.O :
    * IRADIMED CORPORATION WITHDRAWS 510(K) WITH PLANS TO
RESUBMIT
AFTER FURTHER DISCUSSIONS WITH FDA
    * IRADIMED CORP - SEES THIRD-QUARTER REVENUE TO BE
APPROXIMATELY
$13.4 MILLION, UP 23% FROM PRIOR YEAR
    * IRADIMED CORP - ORDERS BOOKED IN QUARTER EXCEEDED OUR
SHIPMENTS
    * IRADIMED CORP - ANNOUNCED THAT COMPANY VOLUNTARILY
WITHDREW ITS
510(K) APPLICATION ON OCTOBER 5, 2022, FOR ITS NEXT-GENERATION
MR IV PUMP
    * IRADIMED CORP - FDA REQUESTED ADDITIONAL INFORMATION THAT
WAS
NOT FEASIBLE TO PROVIDE WITHIN FDA'S REVIEW DEADLINE

Source text for Eikon:  ID:nGNXbKtwmS 
Further company coverage:  IRMD.O 
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