IceCure Wins FDA Approval for Minimally Invasive Breast Cancer Treatment

Jerusalem, 5 October, 2025 (TPS-IL) — Israeli company IceCure Medical has won FDA approval for its ProSense cryoablation system, a minimally invasive treatment for low-risk breast cancer in women aged 70 and older. The outpatient procedure destroys tumors by freezing them, avoiding surgery and preserving breast shape.

ProSense offers results similar to standard lumpectomy, with short recovery—most patients return to normal activity within a day. CEO Eyal Shamir said it gives patients “the choice to freeze their cancer, not their lives.”

FDA approval follows IceCure’s U.S.-based ICE3 trial, which showed low recurrence rates and high patient satisfaction. A post-market study involving 400 patients is planned to gather further data.