Story perspectives

FDA Approves Noninvasive Cryoablation for Older Breast Cancer Patients

10/10/2025

Summary

Story summary

The FDA approved the ProSense Cryoablation System for women aged 70 and older with early-stage, low-risk breast cancer.
This noninvasive treatment uses liquid nitrogen to freeze tumors, providing a less painful alternative to lumpectomy.
The approval follows the ICE3 trial, which reported a 5-year recurrence rate of 3.7%.
IceCure Medical estimates that approximately 46,000 women in the U.S. qualify for this treatment annually.
The FDA mandates a post-marketing study to verify long-term benefits due to concerns about the trial's nonrandomized design.

1 of 1

Story summary

The FDA approved the ProSense Cryoablation System for women aged 70 and older with early-stage, low-risk breast cancer.
This noninvasive treatment uses liquid nitrogen to freeze tumors, providing a less painful alternative to lumpectomy.
The approval follows the ICE3 trial, which reported a 5-year recurrence rate of 3.7%.
IceCure Medical estimates that approximately 46,000 women in the U.S. qualify for this treatment annually.
The FDA mandates a post-marketing study to verify long-term benefits due to concerns about the trial's nonrandomized design.