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

United Imaging Intelligence Achieves Significant Regulatory Milestone

In a notable development for medical technology and artificial intelligence, United Imaging Intelligence (UII) has successfully reached a significant milestone. As of July 2025, the company has secured CE certification for 31 of its AI medical applications, with 18 additional applications confirmed in July alone. This accomplishment underscores UII's commitment to advancing regulatory standards in the field of medical AI, establishing it as a leader in the industry.

The newly certified AI products encompass a broad range of imaging modalities, including PET/CT, mammography, MRI, and CT scans. These applications address various medical conditions affecting major organs, supporting clinical needs across neurology, oncology, and cardiovascular care, among others. The extensive scope of UII's AI applications not only highlights its regulatory achievements but also demonstrates the real-world benefits they provide in medical practice.

Previous certifications from UII already spanned critical clinical areas such as neurology, cardiology, thoracic medicine, oncology, and nuclear medicine. The comprehensive nature of these solutions addresses the entire clinical workflow, from early detection and diagnosis to medical research. This depth and breadth exemplify UII's capability to add significant value in various clinical settings.

With its medical AI solutions introduced in five European countries—Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey—UII's recent CE certifications are set to enhance its partnerships in these markets. The diverse portfolio allows UII to offer trusted technologies to an increasing number of healthcare providers, facilitating safer, faster, and higher-quality patient care.

Beyond the CE certifications, UII has also garnered 15 approvals from the U.S. FDA and 15 Class III approvals from China's NMPA. Meeting the most stringent global regulatory standards not only highlights UII's international focus but also paves the way for wider deployment of medical AI technologies worldwide.

At UII, there is a steadfast belief that by continually evolving innovations in medical AI, substantial transformations can be achieved in healthcare delivery. Enhanced clinical pathways, improved decision-making processes, and better access to quality services for patients globally are all seen as attainable goals through these advancements.

The push for regulatory excellence is pivotal in establishing trust in medical AI technologies, which could ultimately redefine patient care standards and improve health outcomes. As UII continues its journey in the healthcare technology arena, its legacy of compliance and innovation will undoubtedly contribute to the future of intelligent healthcare.

The recent CE certification milestone cements UII's role in shaping the future landscape of medical AI and serves as an encouragement for ongoing enterprise in this vital field. By maintaining focus on regulatory standards while expanding its technology offerings, UII not only enhances its market position but also champions better healthcare experiences for patients and providers alike.

Conclusion

In summary, United Imaging Intelligence's achievement in certifying 31 applications marks a historic point in the global landscape of medical artificial intelligence. This accomplishment reinforces their leadership and commitment to delivering high-quality healthcare solutions through innovative technology.