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

United Imaging Intelligence Reaches Regulatory Milestone

United Imaging Intelligence (UII) has made a significant advancement in medical technology by achieving a critical regulatory milestone. In July 2025, the company received CE marking approval for an additional 18 medical AI applications, raising its total to 31. This remarkable achievement now positions UII as the leader in the number of CE-certified medical AI products across the globe.

A Comprehensive AI Portfolio

The CE-certified AI applications from UII cover four major imaging modalities: PET/CT, Mammography, MRI, and CT. These applications address a wide variety of medical conditions, ensuring that they can assist with clinical needs in fields such as neurology, oncology, cardiology, and pulmonary care. The extensive range of both modalities and clinical focuses showcases UII’s commitment to delivering significant value in actual medical practice.

Earlier approvals had already established UII’s presence in crucial clinical areas, which included neurology and cancer treatments. The recently awarded CE qualifications enhance the company’s ability to provide tools for early detection, diagnosis, and further medical research, thus supporting healthcare professionals efficiently and effectively.

Expanding Influence in Europe

UII’s medical AI solutions have begun gaining traction in multiple European nations, with implementations noted in Spain, Italy, Bosnia and Herzegovina, Poland, and Turkey. The most recent certifications are expected to facilitate deeper partnerships within the European market. UII aims to broaden its geographic reach and further integrate its products into the healthcare systems of various countries, ultimately promoting safer and higher-quality medical services.

Commitment to Regulatory Standards

This latest approval not only underscores UII’s regulatory excellence within Europe; the company has previously secured an impressive 15 clearances from the U.S. Food and Drug Administration (FDA) as well as 15 Class III approvals from China’s National Medical Products Administration (NMPA). Achieving such stringent regulatory approvals demonstrates UII’s readiness and capability for worldwide expansion of medical AI technologies.

Looking Ahead

United Imaging Intelligence is dedicated to continuously advancing its medical AI innovations. The goal is to reinvent healthcare delivery by optimizing care pathways, enhancing clinical decision-making, and making access to quality services viable for patients on a global scale. By fostering the development of its technology, UII aims to shape a future where healthcare becomes not only more efficient but also more accessible.

In conclusion, UII's achievement in having 31 CE-certified medical AI applications represents both a testament to their rigorous research and development efforts and a significant step towards integrating advanced technology into everyday medical practices. As UII continues to expand its reach and capabilities, healthcare providers stand to benefit immensely, enhancing the quality of care delivered to patients everywhere.