IceCure Medical Receives FDA Marketing Authorization for ProSense® Cryoablation System to Treat Early-Stage Breast Cancer in Elderly Patients
Reuters
Oct 04
IceCure Medical Receives FDA Marketing Authorization for ProSense® Cryoablation System to Treat Early-Stage Breast Cancer in Elderly Patients
**IceCure Medical Ltd. Receives FDA Marketing Authorization for ProSense® Cryoablation System for Breast Cancer** CAESAREA, Israel, Oct. 3, 2025 - IceCure Medical Ltd. (Nasdaq: ICCM) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing authorization to its ProSense® cryoablation system for the local treatment of breast cancer in patients aged 70 and above with biologically low-risk tumors (≤1.5 cm) who are treated with adjuvant endocrine therapy. This authorization applies to patients not suitable for surgery, representing approximately 46,000 women annually in the U.S. The approval follows positive data from IceCure's ICE3 trial, the largest multi-center clinical study of its kind. As part of the FDA's decision, IceCure will conduct a post-market surveillance study involving about 400 patients across 30 sites, with established reimbursement codes supporting the commercial rollout. IceCure is now authorized to commence immediate sales and procedures of ProSense® in the U.S., independent of the post-market study. No other organizations were announced as recipients of this regulatory approval.
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: LN90141) on October 03, 2025, and is solely responsible for the information contained therein.
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