“IceCure Medical, an Israel-based maker of tumor-freezing technology, said Sunday that it had received notification from the US Food and Drug Administration recognizing its ProSense product as a “breakthrough device” to freeze tumors in a number of medical conditions including breast cancer.
The breakthrough devices recognition is given by the FDA for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, IceCure Medical said in a filing to the Tel Aviv Stock Exchange, where its shares are traded.
Being part of the FDA’s Breakthrough Devices Program will enable IceCure to speed up procedures vis a vis the US regulator regarding marketing permits for the device to treat breast cancer patients, the filing said.
The Breakthrough Devices Program gives manufacturers an opportunity to interact with the FDA’s experts via a number of different program options to efficiently address issues as they arise during the premarket review phase by the regulator. This can help manufacturers get feedback from the FDA in a timely way, and manufacturers can expect a prioritized review of their submission, the FDA website says.”
View the whole story here: https://www.timesofisrael.com/icecure-shares-up-as-tumor-freezing-tech-gets-fda-breakthrough-device-nod/