United Imaging Secures FDA Clearance for uAngio® AVIVA Interventional X-Ray System

Latest approval enhances U.S. portfolio with advanced imaging technology for vascular and interventional procedures

United Imaging has received FDA clearance for its uAngio® AVIVA, the company’s first interventional X-ray system in the U.S. market. This ceiling-mounted robotic platform integrates 8-axis intelligent robotics, voice-assisted controls, and AI-powered imaging technology to deliver high-precision imaging and hands-free system operation. The system is engineered to streamline interventional radiology procedures, enabling clinical staff to focus more on patient care by reducing manual workflow and complexity in high-pressure environments.

The uAngio AVIVA represents a significant technological advancement in interventional imaging by introducing real-time voice command features and 3D vision, a first in the industry. These features reduce physical touchpoints during procedures, supporting infection control and improving safety. Additionally, its uVERA IQ imaging system uses proprietary AI algorithms to generate high-resolution images with lower radiation doses, addressing a critical need for safer, more effective imaging in complex fields such as neuro interventions and cardiology. This innovation is poised to enhance clinical accuracy, operational efficiency, and patient outcomes.

With the FDA’s clearance, United Imaging solidifies its position in the U.S. healthcare market by introducing a product that reflects both cutting-edge technology and practical clinical value. The uAngio AVIVA’s development, shaped by feedback from healthcare professionals and employees, exemplifies the company’s user-centered approach to innovation. Combined with United Imaging’s customer-friendly policies like All-in Configurations® and Software Upgrades for Life™, this launch represents a strategic milestone, offering advanced imaging solutions with cost transparency and long-term scalability.


Medtech Spectrum's Summary

FDA Clearance of uAngio® AVIVA: United Imaging received FDA approval for its first interventional X-ray system, uAngio AVIVA, which is a ceiling-mounted robotic platform designed to assist clinicians during complex procedures.

Advanced Features for Clinical Efficiency: The system includes 8-axis robotics, voice control, and AI-powered imaging (uVERA IQ) to improve workflow, reduce radiation dose, and enhance image quality, allowing staff to focus more directly on patient care.

Strategic Market Expansion: With this launch, United Imaging strengthens its U.S. portfolio and continues its commitment to innovation, user-driven design, and transparent, scalable business models like Software Upgrades for Life™ and All-in Configurations®.