IceCure Medical’s ProSense marketing clearance request to be reviewed by FDA

IceCure Medical announced the FDA will convene a Medical Device Advisory Committee for a panel meeting to obtain independent expert advice on scientific, technical, and policy matters related to ProSense to help the FDA make a sound decision. The Advisory Panel is expected to convene in Q4, with an FDA decision on whether to approve ProSense expected by early 2025. The FDA is expected to provide the exact date for the Advisory Panel in the coming weeks. The Advisory Panel will review the body of data available on ProSense as a treatment for early-stage breast cancer. As part of its De Novo Classification Request for Marketing Authorization, IceCure submitted data, including its final ICE3 study results, to the FDA, as part of its request for clearance for ProSense for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.