IceCure Medical announced it has received regulatory approval from the Medical Device Division (AMAR) of Israel’s Ministry of Health for its single cryoprobe cryoablation system, the XSense system and CryoProbes.
As of mid-2024, XSense and its cryoprobes have also received regulatory clearance in the US. Food and Drug Administration (FDA) for all of the indications for which ProSense, the company’s flagship cryoablation system, has already received from the US FDA.
“We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure’s leadership position in liquid-nitrogen based cryoablation,” stated IceCure’s chief executive officer, Eyal Shamir. “The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers, and accelerate recovery time for patients.”
“We are particularly pleased with the breast cancer indication approval in Israel, as we believe the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports accelerated commercial adoption,” Shamir added.
XSense is now approved in Israel for all indications for which ProSense has already received approval in Israel, including general surgery, dermatology, neurology, including cryoanalgesia, thoracic surgery, ear, nose, throat (ENT), gynaecology, oncology (including benign and malignant breast tumours), proctology and urology.
