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GE HealthCare Gets FDA Nod for Next-Generation Cardiac Imaging System


Designed to facilitate optimal imaging quality and dosing for complex cardiology interventional procedures, the Allia IGS Pulse has garnered 510(k) clearance from the Food and Drug Administration (FDA)

A key feature of the Allia IGS Pulse is a monopolar X-ray tube that offers quiet operation and enables steep angulation for enhanced visualization of coronary artery anatomy, according to GE HealthCare, the manufacturer of the Allia IGS Pulse.

GE HealthCare noted that other benefits of the Allia IGS Pulse include:

• a combination of X-ray peak power and reduced pulse width which reduces the motion blue that can be caused by vessels and devices;

• strong image quality for patients with a BMI greater than 30; and

• optimization of seven key imaging parameters, including focal spot shape, with the artificial intelligence (AI) leveraging image chain technology AutoRight PLUS.

Nicolas Dumonteil, M.D., an interventional cardiologist who has been using the Allia IGS Pulse in pilot operations since January 2023 at Clinique Pasteur-Toulouse in Toulouse, France, praises the imaging quality and the adaptability of the system for interventional procedures.

“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,” noted Dr. Dumonteil. “The system is also quite adaptable and versatile to all of my daily situations and procedures — from percutaneous coronary interventions (PCIs) to other complex and structural ones.”

Source link #HealthCare #FDA #Nod #NextGeneration #Cardiac #Imaging #System https%3A%2F%2Fwww.diagnosticimaging.com%2Fview%2Fge-healthcare-fda-nod-next-generation-cardiac-imaging-system www.diagnosticimaging.com

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