Breaking Update
Israeli Medtech Firm IceCure Gains FDA Approval for Post-Market Breast Cancer Study
IceCure Medical's ProSense cryoablation, a minimally invasive breast cancer treatment, is now under FDA review in a post-market study called "ChoICE.".
Jerusalem, 12 March, 2026 (TPS-IL) — Israeli medtech company IceCure Medical has received FDA Approval for its post-market “ChoICE” study of ProSense cryoablation, a minimally invasive treatment for low-risk breast cancer. The U.S.-based study will enroll around 400 patients across 30 clinical sites over three years, with at least 80 patients expected in the first year.
ProSense was cleared in October 2025 for patients aged 70 and older with tumors measuring 1.5 cm or smaller. Following this approval, the FDA requested a post-market study to gather real-world data on the treatment’s use. The U.S.-based “ChoICE” study will enroll around 400 patients across 30 clinical sites over three years, with at least 80 patients expected in the first year. Participating sites can also treat additional patients commercially, supported by a CPT Category III reimbursement code.
