FDA Clears IceCure’s Single Probe Cryoablation System

IceCure Medical Ltd. announced it has received marketing authorization from the US FDA for its next-generation single probe cryoablation system, the XSense Cryoablation System with CryoProbes.

"This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology," commented Eyal Shamir, IceCure's Chief Executive Officer. "The next-generation XSense system is cleared for the same indications as our flagship ProSense system and we believe it has future potential to address other indications in the US for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike."

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.