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Home » FDA clears next-gen image-guided therapy tech from GE HealthCare

FDA clears next-gen image-guided therapy tech from GE HealthCare

October 16, 2023 By Sean Whooley

GE HealthCare Allia IGS Pulse
The Allia IGS Pulse system. [Image courtesy of GE HealthCare]
GE HealthCare (Nasdaq:GEHC)  announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system.

The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless of patient size.

Allia IGS Pulse provides a personalized workspace to meet the operator’s specific needs and preferences. As part of the new image chain, the system features a monopolar X-ray tube used to capture images for interventional procedures. GE HealthCare says the tube — the first of its kind — provides powerful, yet quiet imaging capabilities. Its small footprint also helps clinicians reach steep angulation for better understanding of the coronary artery anatomy.

More about the GE HealthCare Allia IGS Pulse

GE HealthCare also incorporated the latest version of its MyIQ technology into the system. It allows clinicians to select their favorite image look from four different image styles. This one-click capability offers a tailored experience at no additional dose.

Allia IGS Pulse enables high-quality imaging for large and bariatric patients with a BMI greater than 30. Its reduced pulse width and unmatched X-ray peak power helps to decrease motion blur for better visualization of vessels and devices. The system also uses the next-generation AI-based AutoRight Plus intelligent image chain. This helps to optimize seven parameters in real time, including focal spot shape.

Removing the burden of manual adjustments helps clinicians stay focused on the procedure and their patients, GE HealthCare said.

“Interventional cardiology procedures require exceptional image quality,” said Arnaud Marie, GM of interventional for GE HealthCare. “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.”

Filed Under: 510(k), Cardiovascular, Featured, Food & Drug Administration (FDA), Health Technology, Imaging, News Well, Regulatory/Compliance, Software / IT, Vascular Tagged With: FDA, GE Healthcare

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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