Posted by Michael Wonder on 07 Apr 2021
IceCure Medical granted FDA breakthrough device designation for Prosense cryoablation system
5 April 2021 - IceCure Medical announced today that it has been granted designation as a breakthrough device from the U.S. FDA for its lead asset, ProSense, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer.
ProSense is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment of cancer tumours.
