FDA approves IceCure’s ProSense post-market ChoICE study design
IceCure Medical Ltd. ICCM | 0.30 | -0.33% |
The U.S. Food and Drug Administration approved the design of IceCure Medical’s ChoICE post-marketing study for its FDA-cleared ProSense cryoablation system in low-risk breast cancer, a surveillance requirement tied to the agency’s October 2025 marketing authorization. The study is expected to enroll about 400 patients across 30 U.S. sites, and participating facilities may bill procedures using an existing CPT Category III reimbursement code.
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