GE HealthCare’s Allia IGS Pulse imaging system approved by the US FDA


GE HealthCare has announced US Food and Drug Administration (FDA) 510(k) clearance of Allia IGS Pulse a new imaging chain for complex cardiology interventions regardless of patient size.

According to a survey of interventionalists, nearly 50% of interventional procedures are performed at working positions where clinicians have poor access to user interface functions and display.GE HealthCare said in a press release. The Allia image-guided system (IGS) is designed to address these challenges, by providing a personalised workspace that meets the operator’s specific needs and preferences, the company says in a press release.

The system features the first monopolar X-ray tube used to capture images for interventional procedures, which the company describes as powerful, yet quieter than normal conversation to optimise the operating environment during a procedure.

The small footprint of the new tube also helps clinicians reach steep angulation for better understanding of coronary artery anatomy, even with the 30cm detector configurations. The latest version of MyIQ technology incorporated into the system allows clinicians to select their favourite image look from four different image styles with just one click for a tailored experience at no additional dose, GE HealthCare adds.

Since January 2023, Allia IGS Pulse has been in pilot operations at Clinique Pasteur, Toulouse (Toulouse, France).

“At Clinique Pasteur in Toulouse, we perform thousands of interventional cardiology procedures each year,” says Nicolas Dumonteil, an interventional cardiologist at Clinique Pasteur, Toulouse. “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 (PCIs) to other complex and structural ones.”

“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 are particularly important,” says Dr Raphaël Philippart, Interventional Cardiologist, Clinique Pasteur, Toulouse.


Please enter your comment!
Please enter your name here