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FDA Clears United Imaging's uAngio AVIVA: First Interventional X-ray System with Voice Control

• United Imaging's uAngio AVIVA, the company's first Interventional X-ray system, has received FDA clearance, featuring industry-first intelligent voice-assist technology for hands-free operation during procedures.

• The ceiling-mounted system incorporates 8-axis robotics providing exceptional clinical flexibility, full lab coverage, and easy tableside access while navigating complex medical equipment in interventional settings.

• United Imaging's proprietary AI algorithms power the uVERA IQ intelligent imaging technology, delivering high-quality images at low radiation doses for interventional radiology, neuro interventions, and cardiology procedures.

United Imaging announced today that the U.S. Food and Drug Administration (FDA) has cleared its uAngio AVIVA system, marking the company's first entry into the interventional X-ray market. The ceiling-mounted system introduces groundbreaking voice control technology designed to enhance procedural focus and efficiency in interventional suites.
The uAngio AVIVA represents a significant advancement in interventional imaging technology, featuring what the company describes as the industry's first intelligent voice-assist system. This innovation allows clinical staff to use voice commands for image review and system movement, enabling them to maintain focus on patients during complex procedures.
"Our goal is to allow the staff's focus to remain on the patient," said Edgar Alvarez, Vice President of the X-ray portfolio at United Imaging's U.S. operations. "We hone in on that by giving them an intuitive user experience, streamlined workflows, and fantastic image quality at low dose."

Intelligent Voice Assist and 3D Vision

The system's voice control capabilities represent a pioneering development in interventional imaging. By enabling hands-free operation, the technology allows clinical staff to maintain sterile conditions while manipulating images and adjusting equipment positions. This feature addresses a common challenge in interventional suites where maintaining sterility while accessing controls can interrupt workflow and potentially compromise patient care.

Advanced Robotics for Enhanced Flexibility

The uAngio AVIVA utilizes an 8-axis ceiling-mounted robotic system that provides exceptional positioning flexibility. This design allows for complete lab coverage and easy tableside access while effectively navigating around other medical equipment in the interventional suite. The advanced robotics enable precise positioning for optimal imaging angles during complex procedures.

AI-Powered Imaging Technology

At the core of the system is United Imaging's proprietary uVERA IQ intelligent imaging technology. This platform leverages artificial intelligence algorithms to produce high-quality images while minimizing radiation exposure. The system is designed to support a wide range of applications including interventional radiology, neuro interventions, and interventional cardiology procedures.
Jeffrey M. Bundy, Ph.D., CEO of United Imaging Healthcare North America, emphasized the collaborative development process behind the system. "Our employee's voices across America trained the system's voice commands, and our customers gave us the insights we needed to shape this innovative system," Bundy stated. "It is exciting to continue bringing industry firsts to healthcare."
Bundy also highlighted the company's unique business approach, noting that the uAngio AVIVA will be offered with United Imaging's "All-in Configurations" and "Software Upgrades for Life" programs. These initiatives aim to provide more transparent and predictable costs for healthcare providers purchasing advanced imaging technology.

Market Availability

The newly FDA-cleared uAngio AVIVA will soon be available for demonstration at United Imaging's recently expanded Houston headquarters, alongside the company's other imaging modalities. This expansion represents United Imaging's growing presence in the North American medical imaging market since its founding in 2011.
The company's North American headquarters in Houston houses corporate offices, manufacturing facilities, a product showroom, service training center, and service parts distribution center. United Imaging has positioned itself with a mission of "Equal Healthcare for All" and continues to expand its digital portfolio across global markets.
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