#China #Shanghai #United Imaging #Medical AI #CE Marking

United Imaging Intelligence Achieves CE Marking for Medical AI Applications

In a groundbreaking development in the medical AI landscape, United Imaging Intelligence (UII) has recently announced that it has reached a noteworthy milestone with 31 of its medical AI applications officially receiving CE marking. This recognition comes five months after the company celebrated the certification of 18 new AI applications in July 2025, making UII the leader in the market with the highest number of CE-certified AI products for medical use worldwide.

The breadth of UII's newly certified portfolio encompasses four major imaging modalities: PET/CT, Mammography, MRI, and CT. These applications support a wide array of clinical needs, effectively addressing significant health issues spanning from neurology and oncology to cardiovascular, pulmonary, and musculoskeletal care. By achieving this extensive regulatory recognition, UII sets a new standard, showcasing not only the scale of its achievements but also the practical benefits its AI technology brings to medical practices across the globe.

Expanding the Horizon of Medical AI

United Imaging's continuous efforts to innovate and certify its AI applications reflect a commitment to enhancing healthcare. Prior to this announcement, UII had already gained CE approval for applications focusing on critical clinical domains, including cardiology, thoracic care, and nuclear medicine. This comprehensive approach ensures that their solutions effectively integrate throughout all stages of the clinical workflow—from early detection to diagnosis and even medical research.

As of now, UII's medical AI solutions retain a robust presence across Europe, having been adopted in five countries: Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey. The recent certifications mark a pivotal moment for UII as they expand their existing partnerships and aim to impact even more healthcare providers in these markets. Leveraging their vast AI portfolio, the company is set to enable healthcare institutions to deliver safer, quicker, and more efficient medical care to patients, making quality healthcare services more accessible.

Aiming for Global Challenges

Moreover, UII has not limited its focus solely to CE certification. The company has also achieved important clearances from regulatory authorities in other regions, having received 15 approvals from the U.S. Food and Drug Administration (FDA) and another 15 Class III approvals from China's National Medical Products Administration (NMPA). This commitment to meet stringent international regulatory standards underscores UII's readiness for global engagement and its ambition to expand the adoption of medical AI technologies worldwide.

The team at UII firmly believes that by advancing medical AI innovations, they can revolutionize healthcare delivery, optimize care pathways, enhance clinical decision-making processes, and ultimately improve patient outcomes across a variety of healthcare settings.

Conclusion

With the 31 CE-certified medical AI applications, United Imaging Intelligence confirms its position at the forefront of healthcare technology, paving the way for a new era in medical diagnostics and treatment. As the company continues to innovate and expand its operations internationally, the future of healthcare appears bright, driven by advanced AI solutions that promise to transform the way patients receive medical care.