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# FDA Delays Decision on Breast Cryoblation Device
- URL: https://www.fdaweb.com/fda-delays-decision-on-breast-cryoblation-device/
- Published: 2025-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:55:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158865

IceCure Medical says FDA has delayed its review decision on the company’s de novo marketing authorization request for ProSense and its use in early-stage low-risk breast cancer with endocrine therapy. The decision was expected this quarter and now the company says it should be issued next quarter, adding that it is working in close collaboration with FDA toward a decision.

The cryoblation system is intended to be used as an alternative to breast-conserving surgery (lumpectomy). It works by ablating localized breast tumors in early-stage, low-risk breast cancer patients.

In November, the agency held an advisory committee meeting to obtain expert advice on scientific, technical and policy matters related to the device. The panel voted 9 to 5 to recommend the device’s authorization, according to the company, adding that three who voted “no” stated that if FDA applied adequate special controls, this would have swayed their opinion to support it.