FDA approves IceCure’s ChoICE post-market study design for ProSense in low-risk breast cancer

Reuters03-11
FDA approves IceCure’s ChoICE post-market study design for ProSense in low-risk breast cancer

The FDA approved the study design for IceCure’s post-marketing ChoICE study evaluating ProSense cryoablation in the local treatment of low-risk breast cancer. IceCure said patient enrollment is expected to begin in the second half of 2026, with at least 80 patients targeted in the first year. The study is expected to enroll about 400 patients across 30 U.S. clinical sites within 36 months.

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