FDA Clears New Interventional X-Ray Platform from United Imaging

The Food and Drug Administration (FDA) has granted 510(k) clearance for the uAngio AVIVA interventional radiology X-ray system, which is reportedly the first interventional platform to offer a voice-assist component.

The intelligent voice assist enables hands-free image review and movement for interventional radiologists, according to United Imaging, the manufacturer of uAngio AVIVA.

United Imaging said other key attributes of the uAngio AVIVA platform include easy tableside access and flexibility with the 8-axis ceiling-mounted robotic system as well as proprietary artificial intelligence (AI) algorithms that facilitate quality low-dose imaging for a variety of interventional procedures.

“It is exciting to continue bringing industry firsts to healthcare. And, as with all the technology we offer, we are bringing it to market with All-In Configurations, Software Upgrades for Life™, and the other groundbreaking business models we've invented to make it simpler and more cost transparent for healthcare providers to purchase,” noted Jeffrey M. Bundy, Ph.D., the CEO of United Imaging Healthcare North America.