GE HealthCare’s Allia IGS Pulse Receives FDA Clearance for Cardiac Imaging

October 16, 2023—GE HealthCare announced FDA 510(k) clearance of the latest addition to the company’s image guided system (IGS) portfolio—Allia IGS Pulse, which features a new imaging chain engineered to provide imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size.

According to the company, Allia IGS Pulse is designed to address the challenges of working positions where clinicians have poor access to user interface functions and display; it provides a personalized workspace that meets the operator’s specific needs and preferences.

Additionally, GE HealthCare advised that as part of its new image chain, the system features a monopolar x-ray tube used to capture images for interventional procedures. This tube is powerful, yet quieter than normal conversation to optimize the operating environment during a procedure. The small footprint of the new tube helps clinicians reach steep angulation for better understanding of coronary artery anatomy, even with the 30-cm detector configurations.

The company’s press release outlined other features of the system including the latest version of MyIQ technology that allows clinicians to select their favorite image look from four different image styles with one click for a tailored experience at no additional dose; exceptional image quality for large and bariatric patients with a body mass index > 30; and reduced pulse width and X-ray peak power help decrease motion blur for better visualization of moving elements such as vessels and devices.

AutoRight Plus, the company’s next-generation automation platform for image chain that leverages AI, allows Allia IGS Pulse to optimize seven parameters in real time, including focal spot shape. It removes the burden of manual adjustment during procedures. A suite of tools supports dose efficiency, dose reduction, and dose awareness.

Since January 2023, the Allia IGS Pulse system has been in pilot operations at Clinique Pasteur - Toulouse in Toulouse, France, where Nicolas Dumonteil, MD, and Raphaël Philippart, MD, are interventional cardiologists.

“At Clinique Pasteur in Toulouse, we perform thousands of interventional cardiology procedures each year,” commented Dr. Dumonteil in GE HeathCare’s press release. “As an operator of the Allia IGS Pulse system, I felt a significant and real improvement in the imaging quality, as well as a significant reduction of this noise in my daily procedures, which gave me great confidence and comfort in the operating room. The system is also quite adaptable and versatile to all of my daily situations and procedures—from percutaneous coronary interventions to other complex and structural ones.”

Dr. Philippart added, “I saw a significant improvement in the image quality, especially with obese patients and complex angioplasties—where a good visibility of my guidewire, balloons, and stents is particularly important.”