GE Healthcare Receives FDA 510(k) Clearance for Allia IGS Pulse, a Next-Generation Image-Guided Therapy System

Oct 18, 2023 18:04 CST Updated 18:04

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Source:Medtech Dive

GE Healthcare today announced FDA 510(k) clearance for its Allia IGS Pulse system.

Allia IGS 7

GE HealthcareTherapyThe latest member of the Image Guided System (IGS) product family features a new imaging chain.GE HealthcareTherapyIt stated that this function was designed to provide superior imaging at the correct dose, which can significantly impact complex cardiology interventions regardless of the patient's body size.

Allia IGS Pulse provides a personalized workspace to meet the specific needs and preferences of operators. As part of the new imaging chain, the system uses a monopolar X-ray tube for capturing images during interventional procedures.GE HealthcareTherapyThe company stated that this tube is the first of its kind, offering powerful and quiet imaging capabilities. Its small footprint also helps clinicians achieve steep angles for better visualization of coronary anatomy.

GE HealthcareThe latest version of MyIQ technology will also be incorporated into the system.It allows clinicians to select their preferred image appearance from four different imaging styles.This one-touch function provides a tailored experience without the need for additional doses.

Allia IGS Pulse provides high-quality imaging for large obese patients with a BMI greater than 30. Its reduced pulse width and unparalleled X-ray peak power help minimize motion blur.Thereby better visualizing blood vessels and devices.The system also adopts the AI-based next-generation AutoRight Plus intelligent image chain. This helps to optimize seven parameters in real time, including focal spot shape.

GE HealthcareTherapySaid that eliminating the burden of manual adjustments helps clinicians focus on surgery and patients.

"Interventional cardiology procedures require exceptional image quality,"GE HealthcareTherapyArnaud Marie, General Manager of the Interventional Division, said, "I am delighted to add Allia IGS Pulse to our interventional portfolio because it addresses the challenges that clinicians continually tell us they face in their daily practice. By developing new features to further enhance our core platform, we are helping to reduce complexity and improve the operating environment so that clinicians can have a personalized workspace, better enabling them to focus on the patient."

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