en.Wedoany.com Reported - On May 7, 2026, the intelligent application—a chest CT image-assisted diagnostic software—promoted for pilot-scale testing by the China National Artificial Intelligence Application Pilot Base (Medical Field), successfully entered the Special Review Procedure for Innovative Medical Devices of the China National Medical Products Administration. This is the nation's first large model, multi-disease AI medical product to enter this review pathway, marking significant progress in accelerating medical large models toward large-scale clinical application.
The Special Review for Innovative Medical Devices is a priority review and approval pathway established by the National Medical Products Administration to encourage medical device innovation. Selected products must meet conditions such as core technological innovation, being first-of-its-kind domestically or internationally leading, and possessing significant clinical value. Only a small number of medical device products nationwide are selected each year.
This product was jointly developed by the China Shanghai Pilot Base and United Imaging Intelligence, positioned as the world's first "One-Stop Chest Screening Agent." Given the current situation where top-tier hospitals in China read an average of approximately 3,500 to 4,000 CT scans daily, nearly half of which are chest CT images, doctors frequently switch between multiple disease-specific AI applications when diagnosing complex cases. This not only fragments the diagnostic thought process but also prolongs patient waiting times. The agent is designed and developed specifically to address these pain points. It can identify nearly a hundred types of abnormal lesions based on a single chest CT image, with a diagnostic accuracy rate of 97.8%, and automatically generate diagnostic reports comparable to the level of junior attending physicians. This drives the transformation of the traditional reading model of "one reporting doctor plus one reviewing doctor" to "AI assistance plus one reviewing doctor," allowing doctors to devote more energy to complex case judgment and clinical decision-making.
The clinical value of this agent has been confirmed through multi-center validation. Currently, the product has been deployed in nearly 30 hospitals nationwide, including Zhongshan Hospital Affiliated to Fudan University, Peking University People's Hospital, Sichuan Provincial People's Hospital, and Shanghai General Hospital, processing over 2.5 million cases cumulatively, breaking through the translational bottleneck of medical AI moving from research paper results to real clinical application. Ye Xiaodan, Chief Physician of the Radiology Department at Zhongshan Hospital Affiliated to Fudan University, stated: "Through multi-center validation, the One-Stop Chest Screening Agent has helped us actually shorten the image reading time by 33%. We have all genuinely experienced the burden reduction and efficiency improvement brought by the large model."
The implementation of the One-Stop Chest Screening Agent not only reshapes doctors' image reading workflow but is also changing patient health management models. Traditional diagnosis and treatment start from symptoms and conduct examinations around a single disease, whereas "One-Stop Screening" can systematically screen and identify multiple potential abnormalities through a single examination. Based on the doctor's professional judgment, it helps patients obtain a more comprehensive and earlier diagnosis, promoting the upgrade of medical services from passive treatment of "treating existing diseases" to proactive health management of "preventing diseases before they arise."
In terms of technological expansion, United Imaging Intelligence is extending the "One-Stop Screening" capability to more parts of the body. Zhou Xiang, Co-CEO of United Imaging Intelligence, revealed that the company's brain CT/MR modality One-Stop Screening Agent can detect 74 common diseases and abnormalities based on a single brain MR scan, and 43 common diseases and abnormalities based on a single brain CT scan, providing support for the early identification and precise diagnosis of major diseases such as stroke, brain tumors, and Alzheimer's disease.
The National Artificial Intelligence Application Pilot Base (Medical Field), with Zhongshan Hospital Affiliated to Fudan University as the main entity, began construction in 2025. Currently, the Shanghai Pilot Base has preliminarily established a pilot-scale verification platform integrating computing power infrastructure, a corpus knowledge base, medical large models and agents, and multi-scenario clinical validation and evaluation, laying a solid foundation for the large-scale application of "Artificial Intelligence + Clinical Medical Research." At this stage, the base has released multiple phased achievements and selected 51 high-quality outcomes from over 200 medical AI applications for pilot-scale promotion, continuously driving the clinical translation and implementation of cutting-edge medical AI technologies. The successful entry of this chest CT image-assisted diagnostic software into the Special Review Procedure for Innovative Medical Devices is both a concentrated reflection of the Shanghai Pilot Base's construction effectiveness and a key node for China's medical large models moving from technical validation to regulatory compliance and market access.
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