GE HealthCare Gets FDA OK for Allias IGS Pulse

GE HealthCare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Allia IGS Pulse, the latest addition to its image-guided system (IGS) portfolio.
 
Allia IGS touts a new imaging chain that according to GE HealthCare is designed to offer imaging at the correct dose for visible impact in complex cardiology interventions for patients of most any size.
 
The system features the first monopolar x-ray tube used to capture images for interventional procedures. This new tube is powerful, yet quieter than normal conversation4 to optimize the operating environment. The tube’s small footprint also helps clinicians reach steep angulation for better understanding of coronary artery anatomy, even with the 30 cm detector configurations. The latest version of MyIQ technology incorporated into the system allows clinicians to select their favorite image look from four different styles with just one click.
 
According to GE HealthCare, with Allia IGS Pulse, interventionalists can get exceptional image quality for large and bariatric patients with a BMI of greater than 30.
 
To relieve clinicians and technologists of the complex task of optimizing image quality and dose during procedures, Allia IGS Pulse takes AutoRight, the company’s intelligent image chain leveraging AI, a step further with AutoRight PLUS—the next generation of the automation platform. With AutoRight PLUS, the system now optimizes seven parameters in real time, including Focal Spot Shape. By removing the burden of manual adjustment during procedures, clinicians can stay focused on the procedure and treatment of their patients. To further optimize dose along the image chain, a suite of tools is also available to help support dose efficiency, reduction, and awareness.
 
“Interventional cardiology procedures require exceptional image quality,” Arnaud Marie, GM of Interventional for GE HealthCare told the press. “I’m excited by the addition of Allia IGS Pulse to our interventional offerings because it addresses the very things clinicians continue to tell us present challenges in their day-to-day practice. By developing new features to further evolve our core platform, we’re helping to reduce complexity and improve the operating environment so that clinicians can have a personalized workspace that better enables them to keep their focus where it belongs—on their patients.”