IceCure rises on FDA's positive response for De Novo review request

Icecure Medical

30/01/2024 18:57

** Shares of Israel-based med-tech co IceCure Medical
 ICCM.O  rise ~1% to $1.39
    ** Co says FDA responded affirmatively to its request for
supervisory review regarding a prior denial of De Novo
Classification Request for co's breast cancer treatment
    ** De Novo classification is a risk-based classification
process, which provides a marketing pathway to classify novel
medical devices
    ** The FDA determined there is sufficient basis to re-open
the De Novo file and requested co to submit the full 5-year
dataset from its late-stage trial for the treatment
    ** Up to last close, stock up 24.4% in last 12 months

    

 (Reporting by Christy Santhosh)
 ((Christy.Santhosh@thomsonreuters.com))