IceCure Medical Wins FDA Approval for ProSense Cryoablation System for Low-Risk Breast Cancer

Reuters

2025/11/19

IceCure Medical Wins FDA Approval for ProSense Cryoablation System for Low-Risk Breast Cancer

IceCure Medical Ltd. has received significant regulatory approvals for its cryoablation technologies. The company announced that its ProSense® system has been granted FDA marketing authorization for the treatment of low-risk breast cancer in women aged 70 and above and patients not suitable for surgery, marking a major milestone that opens the U.S. market for its minimally invasive technology. In addition, ProSense® and its cryoprobes are now cleared for commercial sale in Switzerland for use in the treatment of malignant or benign tissue in the breast, lung, liver, kidney, and musculoskeletal system, including palliative care. Furthermore, Israel has granted regulatory approval for IceCure's next-generation XSense™ Cryoablation System for breast cancer and other indications, while XSense™ and its cryoprobes have received a Notice of Allowance for patents in both the U.S. and Japan, strengthening the company's intellectual property portfolio.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. IceCure Medical Ltd. published the original content used to generate this news brief via PR Newswire (Ref. ID: IO28579) on November 19, 2025, and is solely responsible for the information contained therein.

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