FDA Approval Paves the Way for IceCure Medical's ProSense Cryoablation Device in the US
ByAinvest
Tuesday, Jan 13, 2026 4:27 pm ET1min read
ICCM--
IceCure Medical (ICCM) has received FDA approval for its ProSense cryoablation device, marking a significant milestone in its US market strategy. The company reported record-breaking sales in North America for Q4 2025, driven by increased demand and strategic installations at leading institutions. Despite strong sales growth, IceCure faces financial challenges, including negative margins and a low Altman Z-Score indicating potential financial distress.
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