IceCure Medical granted FDA Advisory Panel meeting date for ProSense

IceCure Medical announced that the FDA’s Medical Device Advisory Committee Panel is scheduled to take place on Thursday, November 7. The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Following the Advisory Panel, IceCure anticipates that the FDA will make a decision regarding marketing clearance of ProSense by early 2025. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.