#Shanghai #United States #United Imaging #Medical AI #CE Mark

United Imaging Intelligence Achieves Regulatory Landmark

United Imaging Intelligence (UII) has recently achieved a significant milestone in the field of regulatory excellence by obtaining CE certification for a total of 31 medical AI applications. This milestone was reached in July 2025, when the company was awarded CE marking for 18 additional AI applications, setting a new global standard in medical AI certification.

The breadth of UII’s newly certified applications spans across four major imaging modalities including PET/CT, mammography, MRI, and CT. This comprehensive range enables UII's solutions to address various clinical needs, from neurology and oncology to cardiovascular, pulmonary, and musculoskeletal care. The recent certifications not only highlight UII's regulatory prowess but also emphasize the tangible value that their AI solutions contribute to real-world medical practice.

Enhancing Clinical Workflow with AI

UII's certified offerings cater to a wide array of clinical workflows, encompassing everything from early detection and diagnosis to medical research. Their AI solutions are geared to streamline clinical processes, ensuring that healthcare providers can deliver safer, faster, and higher-quality care to patients. The company's existing CE certifications have already covered critical clinical areas such as neurology, cardiology, thoracic care, oncology, and nuclear medicine.

With such an extensive product range, UII stands as a global benchmark not only in terms of regulatory recognition but also in the real-world applicability and efficacy of its AI technologies.

Broadening European Collaboration

Presently, UII's medical AI solutions have been adopted in five European countries, including Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey. The recent CE certifications are set to expand UII’s collaborative efforts across the European market significantly. By offering comprehensive AI portfolios, UII is empowering healthcare professionals to provide improved care.

Meeting Global Regulatory Standards

In addition to the 31 CE certifications, UII has successfully secured 15 FDA approvals in the United States and 15 Class III approvals from the China NMPA, showcasing its compliance with some of the world's most rigorous regulatory standards. This capability demonstrates UII’s global preparedness and paves the way for broader adoption of medical AI technologies.

UII envisions that by continually advancing medical AI innovations, it can transform the landscape of healthcare delivery. Their mission includes optimizing care pathways, improving clinical decision-making, and ensuring that quality services are more accessible to patients worldwide.

With such forward momentum, UII is poised to continue shaping the future of medical AI, setting highest standards for regulatory excellence and patient care quality. The firm’s efforts are pivotal in fostering global trust in intelligent healthcare solutions, ultimately leveraging technology for enhanced patient outcomes.