IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel

Application covering a wide range of indications is in line with trends in de-escalation of surgery and growth in minimally invasive cryoablation procedures, pointing to strong potential for increasing demand

CAESAREA, Israel, Feb. 24, 2025 /PRNewswire/ — IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”, “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has filed for regulatory approval with the Medical Device Division (“AMAR”) of Israel’s Ministry of Health for its next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes.

The filing contains a request for approval of all indications for which ProSense® has already received approval in Israel, including general surgery, dermatology, neurology, including cryoanalgesia, thoracic surgery, ENT (ear, nose, throat), gynecology, oncology (including benign and malignant breast tumors), proctology and urology. The Company has already received marketing authorization from the United States Food and Drug Administration (the “FDA”) for the XSense™ System and its cryoprobes.

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