# FDA Grants First-Ever Marketing Authorization for a Medical Device to Treat Low-Risk Breast Cancer in Women 70 and Older

> fda · REPORTED · 2026-01-01

The FDA granted marketing authorization to IceCure Medical's ProSense cryoablation device for local treatment of low-risk breast cancer in women aged 70 and above receiving endocrine therapy, making it the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer. The addressable U.S. population is estimated at approximately 46,400 early-stage low-risk breast cancer patients aged 70 and over annually.

About IceCure Medical: IceCure Medical is a medical device company that develops and commercializes the ProSense cryoablation system, a minimally invasive device that destroys tumors using extreme cold, targeting early-stage breast cancer and other solid tumors as an alternative to surgery.

- Company: IceCure Medical
- Sector: oncology
- Primary source: https://www.sec.gov/Archives/edgar/data/1584371/000121390026003172/ea027250301ex99-1_icecure.htm

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.