IceCure Medical Ltd. (ICCM) announced Monday it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its next-generation single probe cryoablation system, the XSense Cryoablation System with CryoProbes.
XSense and its cryoprobes are cleared for all of the indications for which ProSense has already received the requisite FDA clearance, including general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology and urology.
The system is designed to destroy tissue by the application of extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions and warts.