IceCure Medical wins FDA breakthrough device designation for cryoablation system

IceCure Medical today said it 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. It is designed for use in the treatment of TI invasive breast cancer or in patients not suitable for surgical alternatives for treating breast cancer.

“We are thrilled to receive the breakthrough device designation from the FDA for our lead asset, ProSense, based on promising clinical outcomes in multiple clinical studies to date. ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumor therapy,” CEO Eyal Shamir said in a news release.

As part of the breakthrough device program, the Me…

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