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FDA designates breakthrough therapy for IceCure's medical device


Key points from article :

IceCure Medical received FDA breakthrough device designation for its ProSense cryoablation system.

ProSense is a liquid nitrogen-based cryoablation system that is a minimally invasive treatment for cancer tumors.

Designed for use in TI invasive breast cancer or in patients not suitable for surgical alternatives for treating breast cancer.

“Exceptionally safe and effective minimally invasive cryoablation approach to tumor destruction," - Eyal Shamir, CEO.

Medicare coverage for devices like the ProSense for a four-year duration.

“ProSense has already received FDA approval for general minimally-invasive cryoablation applications."

"IceCure is further pursuing FDA-specific approval for breast cancer with its ongoing ICE3 clinical trial."

"Interim results to be presented at the American Society of Breast Surgeons Annual Meeting on April 30."

Cryoablation system using liquid nitrogen sets new standards for treating breast cancer

Mentioned in this article:


Non-profit organization for breast surgeons

Company Representative

CEO of IceCure Medical


Israeli medical device company