The US Food and Drug Administration (FDA) has granted marketing authorisation for IceCure Medical’s XSense Cryoablation System with CryoProbes.

This next-generation single probe system is designed for minimally invasive tumour destruction through extreme cold application.

The XSense system is now cleared for the same indications as its predecessor, the ProSense system, covering a wide range of medical fields. These include general surgery, dermatology, thoracic surgery, neurology, ENT, oncology, gynaecology, proctology, and urology.

It is capable of treating various conditions such as fibroadenomas, liver metastases, kidney tissue, tumours, skin lesions, and warts.

The technology behind IceCure’s offerings, including both the ProSense and XSense systems, offers a minimally invasive treatment option for tumour treatment.

By using liquid nitrogen, these systems can create extensive lethal zones, effectively destroying benign and malignant lesions in organs like the kidney, breast, lung, and liver.

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IceCure CEO Eyal Shamir said: “This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology.

“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.”

In March 2024, IceCure obtained the Japan Patent Office’s Notice of Allowance for a patent application related to its ProSense cryoablation technology.

The ProSense cryoablation technology uses advanced cryogen flow control to maintain precise temperature.