AdComm to Review IceCure De Novo Marketing Request for ProSense, Decision Expected Early 2025

 

• Demonstrates public health importance of assessing ProSense®'s potential to offer optimal treatment that benefits women with early-stage breast cancer
• Patients, patient advocacy groups, doctors, and the general public will be welcome to participate and comment in the open public hearing
• IceCure welcomes a transparent public forum to share ICE3 study results and show how ProSense® cryoablation could potentially offer a minimally invasive alternative treatment to women diagnosed with early-stage breast cancer estimated at 65,000 in the U.S. annually
• ProSense® is already approved for the treatment of early-stage breast cancer in numerous European countries, as well as Brazil, India, and China 

https://www.biospace.com/article/releases/fda-to-convene-advisory-panel-for-review-of-icecure-s-de-novo-marketing-clearance-request-for-prosense-decision-expected-early-2025-aligns-with-commercial-readiness-plan/