On September 15, 2025, IceCure Medical Ltd. announced it has received regulatory approval from the Medical Device Division of Israel's Ministry of Health (AMAR) for its next-generation single cryoprobe cryoablation system, the XSense™ System and CryoProbes. This approval covers a broad range of indications, including breast cancer, general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.
The XSense™ system and its cryoprobes have also received regulatory clearance in the United States from the U.S. Food and Drug Administration (FDA) for all indications currently approved for ProSense®, the company's flagship cryoablation system. This dual regulatory success for XSense™ in key markets underscores its potential for widespread adoption and commercial growth.
IceCure's CEO, Eyal Shamir, stated that this latest regulatory approval reaffirms IceCure's leadership position in liquid nitrogen-based cryoablation. The minimally invasive cryoablation option offered by XSense™ aims to de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients, particularly with the breast cancer indication approval in Israel supporting accelerated commercial adoption.
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