A nonsurgical treatment to destroy tumors by freezing them has been cleared by the FDA, allowing it to be marketed in the U.S.
IceCure Medical, the Israeli medical device company that developed the cryotherapy technology, previously received general FDA approval for its product, but with the new clearance, it can further commercialize it in the U.S.
The liquid treatment can be applied to benign and cancerous tumors in ear, nose and throat procedures, as well as those in the kidney and liver. The approval also includes IceCure's MultiSense system, which uses three needles and can cut procedure time.
"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," Eyal Shamir, CEO of IceCure Medical, said in a news release.