Brief: Median Technologies: Moving Forward With FDA Interactions For Ibiopsy® Lung Cancer Screening CADe

Median Technologies SA

05/05/2022 17:15

May 5 (Reuters) - Median Technologies SA  ALMDT.PA :
    * MEDIAN TECHNOLOGIES IS MOVING FORWARD WITH THE FDA
INTERACTIONS
FOR ITS IBIOPSY® LUNG CANCER SCREENING CADE/CADX SOFTWARE AS
MEDICAL DEVICE
    * HAS RECEIVED THE FDA’S FEEDBACK FOLLOWING THE 513(G)
REGULATORY
SUBMISSION FOR ITS IBIOPSY® LCS CADE/CADX SOFTWARE AS MEDICAL
DEVICE.
    * WILL PROCEED THROUGH A 510(K) SUBMISSION TO OBTAIN AN FDA
DEVICE
CLEARANCE AND MARKET AUTHORIZATION, TARGETED FOR END 2023.
    * ON MAY 2, 2022, INITIATED A Q-SUBMISSION PROCESS, COMPOSED
OF
SEVERAL SUBMISSIONS, TO REQUEST FEEDBACK FROM THE FDA ON VARIOUS
TOPICS SUCH AS THE PIVOTAL STUDY PROTOCOLS

Source text for Eikon:  ID:nBw6dmlMGa 
Further company coverage:  ALMDT.PA 

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