#China #Shanghai #Medical AI #United Imaging Intelligence #CE Certification

United Imaging Intelligence Achieves CE Certification for Medical AI

In a landmark achievement, United Imaging Intelligence (UII) has strengthened its position as a leader in medical AI regulation by receiving the CE marking for a total of 31 applications, the highest number of certified medical AI products globally. This milestone showcases UII's dedication to regulatory excellence and its commitment to fostering global trust in smart healthcare solutions.

In July 2025, UII expanded its portfolio with 18 additional AI applications that were awarded the CE mark. These applications extend across various imaging modalities, including PET/CT, mammography, MRI, and CT. The breadth of coverage addresses a wide range of diseases affecting numerous body systems. From neurology and oncology to cardiovascular, pulmonary, and musculoskeletal care, UII's certified solutions meet critical clinical needs and demonstrate the tangible benefits of AI in real-world medical practice.

Moreover, UII has previously secured several prominent CE certifications covering essential clinical areas such as neurology, cardiology, thoracic care, oncology, and nuclear medicine. By integrating these solutions into the clinical workflow, UII enhances everything from early detection and diagnosis to medical research. This not only emphasizes the extensive scope of their regulatory recognition but also highlights UII's ability to deliver significant value across diverse clinical settings.

Currently, UII's medical AI solutions are already implemented in five European countries, including Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey. The new CE certifications will facilitate the expansion of UII's partnerships throughout the European market. By leveraging its comprehensive AI portfolio, UII aims to provide reliable technologies that allow more healthcare providers to deliver safer, faster, and higher-quality care.

In addition to its CE certifications, UII has also received 15 approvals from the U.S. FDA and 15 Class III approvals from China's NMPA. Meeting the world's most stringent regulatory standards is a testament to UII's readiness for global expansion and paves the way for broader acceptance and integration of medical AI worldwide.

UII is committed to continuously advancing medical AI innovations to transform healthcare delivery by optimizing care pathways, improving clinical decision-making, and making quality services more accessible to patients everywhere.