On September 10, 2026, IceCure Medical received China’s NMPA approval to market ProSense and associated cryoprobes as a Class III medical device. For investors, the authorization enables commercialization in China, strengthens the company’s stated global regulatory position and expands the markets where ProSense may be commercialized.

Key Highlights

  • IceCure Medical CEO Eyal Shamir said the authorization expands access to the company’s minimally invasive cryoablation technology.
  • ProSense is designed to destroy benign and cancerous tumors by freezing them, with primary focus areas including breast, kidney, bone and lung cancer.
  • IceCure markets ProSense worldwide for approved indications, including in the United States, Europe and Asia.

IceCure Medical Ltd. (NASDAQ: ICCM) can market its ProSense system in China after receiving approval from the National Medical Products Administration on September 10, 2026. The authorization covers the system and its associated cryoprobes under the approved registration.

China Approval Covers ProSense System

The NMPA classified ProSense as a Class III medical device. Chief Executive Officer Eyal Shamir described the authorization as a step toward broader access to IceCure’s minimally invasive technology. He also said the approval expands the markets where ProSense may be commercialized and strengthens IceCure Medical’s global regulatory position. IceCure develops liquid-nitrogen-based cryoablation systems that destroy tumors by freezing them as an alternative to surgical tumor removal. Its stated focus areas include breast, kidney, bone and lung cancer.

China Expands ProSense’s Approved Markets

ProSense is marketed and sold worldwide for indications cleared or approved to date, including in the United States, Europe and Asia. IceCure describes the technology as minimally invasive and says it can be performed in a relatively short procedure. The system is intended for the destruction of benign and cancerous tumors through freezing.