IceCure Submits FDA Regulatory Filing for New XSense™ Cryoablation System with Cryoprobes
Continuous innovation as a global leader in minimally invasive liquid-nitrogen based cryoablation systems
CAESAREA, Israel, April 2, 2024 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure” or the “Company”), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed a 510(k) submission with the United States Food and Drug Administration (“FDA”) for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes. The filing contains a request for clearance for all of the indications for which ProSense® has already received the requisite FDA clearance, including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology.