FDA Expands Clearance of Cryoablation Technology for Kidney, Liver, Head and Neck Tumors

The US Food and Drug Administration (FDA) has expanded the clearance of a cryoablation technology platform for the treatment of cancerous and benign tumors of the kidney, liver, ear, nose or throat, according to a press release from the product’s manufacturer.

The clearance applies to three cryoablation systems—IceSense3, ProSense and MultiSense manufactured by IceCure Medical in Caesarea, Israel. The latter system allows simultaneous treatment with three needles, which can reduce procedure length and improve the treatment of multiple tumors and larger masses. Cryoablation technology uses a nonsurgical liquid nitrogen approach to destroy benign or cancerous tumors by freezing them.

“The additional FDA clearance is a pivotal milestone for IceCure, and we now plan to expand our operational capabilities in the addressable markets for labels with existing CPT codes and reimbursement, while driving further revenues,” Eyal Shamir, CEO of IceCure Medical, said in a press release. “Receipt of this bundled approval is a significant step in our ability to commercialize our products in the US, and we believe this, along with the other achievements, allows us to enter 2020 with plenty of momentum and revenue-generation opportunities.”