Siemens Healthineers Receives NMPA Approval for First China-Made Dual-Source Photon-Counting CT
Siemens Healthineers announced that its first China-made dual-source photon-counting CT (PCCT), the NAEOTOM Alpha.Pro, has received market approval from China’s National Medical Products Administration (NMPA). The approval marks the company’s completion of a dual-track strategy combining imported and locally produced photon-counting CT technology, signaling deeper integration of this advanced imaging technology into China’s domestic industrial chain. The product will be manufactured at Siemens Healthineers’ Shanghai research and production base in Zhangjiang, Pudong.
Siemens Healthineers has established a local team dedicated to the full lifecycle of photon-counting CT products, from definition and research and development to registration and service. A dedicated, high-standard production facility has also been built at the Shanghai base. This localization effort is more than just a transfer of production; it is a deep, full-chain industrial integration. To date, the NAEOTOM Alpha family has performed over 3.5 million scans worldwide and has been installed in 22 provinces in China. More than 1,200 papers have been published about it.
The NAEOTOM Alpha.Pro, a new China-made addition to the NAEOTOM Alpha family, maintains the platform’s technological advantages and adds multi-substance and multi-energy compartment clinical applications. These applications support the diagnosis and treatment of cardiovascular, respiratory, oncological, and metabolic diseases. Siemens Healthineers has announced that a second China-made photon-counting CT equipment is expected to be approved in 2026.
As one of the first multinational medical technology companies to bring core components to China for local production, Siemens Healthineers has already achieved local research and manufacturing of multiple high-end medical devices at its Zhangjiang base, including dual-source CT, whole-body PET/CT, flagship ultrasound systems, and fully automated clinical chemistry and immunoassay analyzers.
