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BioWorld - Saturday, June 6, 2026
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Home » Icecure gets FDA nod for Prosense cryoablation in breast cancer
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Icecure gets FDA nod for Prosense cryoablation in breast cancer

Oct. 6, 2025
By Holland Johnson
Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.
Medical technology Regulatory Cancer Oncology Middle East North Africa U.S. De novo FDA

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