United Imaging Intelligence (UII) has reached a major milestone in regulatory excellence. In July 2025, 18 additional AI applications received CE marking, bringing the company’s total to 31 — the highest number to date of CE-certified for medical AI products worldwide. This accomplishment reinforces UII’s leadership in medical AI regulation and highlights its commitment to fostering global trust in intelligent healthcare.
Expanding AI Capabilities Across Imaging Modalities
The newly certified AI portfolio spans PET/CT, Mammography, MRI, and CT, covering a wide range of diseases throughout the whole body. These applications support clinical needs from neurology and oncology to cardiovascular, pulmonary, and musculoskeletal care. With such breadth across modalities and depth in clinical focus, UII establishes a global benchmark — not only for the scale of regulatory recognition, but also for the tangible value its AI brings to real-world medical practice.
In addition to this year’s certifications, earlier CE approvals already spanned key clinical domains including neurology, cardiology, thoracic care, oncology, and nuclear medicine. Together, these solutions cover the entire clinical workflow from early detection and diagnosis to medical research, while spanning a broad spectrum of imaging modalities. This breadth and depth highlight UII’s ability to deliver real-world value across diverse clinical settings.
In Europe, UII’s medical AI solutions have already been adopted in five countries, including Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey. The recent CE certifications will further expand UII’s partnerships across the European market. Leveraging its comprehensive AI portfolio, UII can bring trusted technologies to more healthcare providers, enabling them to deliver safer, faster, and higher-quality care.
Beyond CE, UII has also achieved 15 clearances from the U.S. FDA and 15 Class III approvals from China’s NMPA. Meeting the world’s most rigorous regulatory standards demonstrates UII’s global readiness and paves the way for broader adoption of medical AI worldwide.
UII believes that by continuously advancing medical AI innovations, we can transform how healthcare is delivered: optimize care pathways, enhance clinical decision-making, and make quality services more accessible to patients around the world.