IceCure’s ProSense® Awaits FDA Panel Review

Icecure Medical (ICCM) has released an update.

IceCure Medical has announced an FDA Advisory Panel meeting scheduled for November 7, 2024, to discuss the marketing authorization of ProSense®, a minimally invasive alternative to lumpectomy for treating early-stage low-risk breast cancer. The ProSense® Cryoablation System, which freezes tumors, could potentially benefit an estimated 70,000 women diagnosed annually in the U.S. Following the panel’s recommendations, the FDA’s decision on the marketing authorization is expected by early 2025.

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