Brief: Icecure Medical Files Appeal With U.S. FDA Requesting A Review Of Its De Novo Classification For Prosense® In Early-Stage Breast Cancer

Icecure Medical

15/11/2023 12:35

Nov 15 (Reuters) - Icecure Medical Ltd  ICCM.O :
    * ICECURE MEDICAL FILES APPEAL WITH U.S. FDA REQUESTING A
REVIEW
OF ITS DE NOVO CLASSIFICATION FOR PROSENSE® IN EARLY-STAGE
BREAST CANCER
    * ICECURE MEDICAL LTD - SEEKS TO COMPLETE REVIEW PROCESS,
ESTABLISH SPECIAL CONTROLS, AND FINALIZE CLASSIFICATION OF
PROSENSE
    * ICECURE MEDICAL LTD - PER FDA'S GUIDELINES, ICECURE
EXPECTS A
RESPONSE TO ITS APPEAL BY END OF JANUARY 2024

Source text for Eikon:  ID:nPn5dxRWna 
Further company coverage:  ICCM.O 

 ((Reuters.Briefs@thomsonreuters.com))