GE HealthCare Receives FDA Clearance of Allia IGS Pulse – the Next Generation of Image-Guided Systems Designed for Cardiac Imaging Excellence

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GE Healthcare has received US FDA 510(k) clearance for Allia IGS Pulse, the latest addition to the company’s image-guided system (IGS) offerings. This system is designed to enhance imaging and dose management for complex cardiology interventions, regardless of the patient’s size.

Cardiovascular disease (CVD) remains a prevalent global health issue, with CVDs being a leading cause of death. As the demand for minimally invasive surgeries continues to grow, GE Healthcare is dedicated to aiding interventional cardiologists, vascular surgeons, and other specialists by providing innovative image guidance technologies to optimize workflows and improve image quality, resulting in better patient care and clinical outcomes.

The Allia IGS Pulse addresses the challenges faced by clinicians during interventional procedures, where they often have limited access to user interface functions and displays. It offers a personalized workspace tailored to the operator’s specific needs and preferences. The system features a monopolar x-ray tube for image capture during interventional procedures, designed to be powerful yet quiet to optimize the procedural environment. The tube’s small footprint allows clinicians to achieve steep angulations for better understanding of coronary artery anatomy. The MyIQ technology incorporated into the system allows clinicians to select from four different image styles with a single click, offering a tailored experience without additional dose.

Image quality and dose management are critical for treating complex cardiovascular diseases, especially in patients of varying sizes. Allia IGS Pulse provides exceptional image quality for large and bariatric patients with a BMI greater than 30. Its reduced pulse width and high X-ray peak power reduce motion blur for better visualization of moving elements, such as vessels and devices. The system employs AutoRight PLUS, an automation platform that optimizes seven parameters in real time, including Focal Spot Shape, to reduce the need for manual adjustments during procedures.

Furthermore, the system offers tools to support dose efficiency, dose reduction, and dose awareness. Since January 2023, Allia IGS Pulse has been in pilot operations at Clinique Pasteur in Toulouse, France, where clinicians have reported improved imaging quality, reduced noise, and enhanced adaptability and versatility for various procedures.

GE Healthcare aims to provide exceptional image quality and dose management, addressing the challenges clinicians face in their day-to-day practice. The goal is to simplify complex procedures and create an environment that allows clinicians to focus on their patients and provide personalized care.

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Author: medtechinnovate.com

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