On February 24, 2025, IceCure Medical Ltd. 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. This application covers a wide range of indications for which the flagship ProSense® system has already received approval in Israel. The XSense™ System and its cryoprobes have already received marketing authorization from the U.S. Food and Drug Administration.
The filing includes requests for approval across general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology (including benign and malignant breast tumors), proctology, and urology. This broad scope of indications highlights the versatility and potential market reach of the XSense™ system. IceCure's CEO, Eyal Shamir, stated optimism about receiving regulatory clearance in Israel in the coming months.
This move aligns with global trends towards de-escalation of surgery and an increase in minimally invasive procedures, which are expected to drive demand in the minimally invasive surgery market. The XSense™ system represents IceCure's commitment to innovation and bringing advanced healthcare solutions to market, further solidifying its leadership in liquid nitrogen-based cryoablation technologies.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.