Why Is Medical Device Firm IceCure Medical Stock Trading Lower Today?
Portfolio Pulse from Vandana Singh
The FDA has denied IceCure Medical Ltd's (NASDAQ:ICCM) De Novo Classification request for the ProSense System for breast cancer. This decision does not affect ProSense's FDA-cleared authorization for other indications in the U.S. IceCure is addressing the FDA's response and continues its ICE3 clinical study, expected to be completed in Q1 2024. ICCM shares are down 35.80%.
September 20, 2023 | 2:51 pm
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FDA denial of IceCure's De Novo Classification request for the ProSense System for breast cancer has led to a significant drop in ICCM shares.
The FDA's denial of IceCure's request is a significant setback for the company, as it limits the potential market for the ProSense System. This has led to a negative investor sentiment, reflected in the 35.80% drop in ICCM shares.
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