MetaMedical™ Solutions Inc

GE HealthCare gets 510(k) clearance for Allia IGS Pulse system

GE HealthCare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new image-guided system, Allia IGS Pulse.

Building on the Allia platform intended for image-guided therapies, the new system is aimed at enhancing workflow to diagnose and treat cardiovascular diseases in interventional cardiology.

The system comes with a new imaging chain designed to deliver better imaging at the appropriate dose for visible effects in complex cardiology interventions, irrespective of the size of the patients.

It is incorporated with what the company claims to be the first monopolar X-ray tube for capturing images during interventional procedures as part of the new image chain.

The newest MyIQ technology integrated into the system enables clinicians to effortlessly choose their preferred image style from four options with a single click.

Interventionalists can use the new system to attain image quality for large and bariatric patients with a body mass index (BMI) of greater than 30.

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The reduced pulse width and X-ray peak power of the system enable lower motion blur for better visualisation of moving elements such as vessels and devices.

To simplify the process of enhancing image quality and managing doses during medical procedures, Allia IGS Pulse utilises AutoRight PLUS, the company’s next-generation artificial intelligence-driven image chain.

AutoRight PLUS helps the system optimise seven parameters in real-time, including Focal Spot Shape.

Since January this year, Allia IGS Pulse has been under pilot operations at Clinique Pasteur in Toulouse, France.

GE HealthCare interventional general manager Arnaud Marie said: “By developing new features to further evolve our core platform, we’re helping to reduce complexity and improve the operating environment so that clinicians can have a personalised workspace that better enables them to keep their focus where it belongs—on their patients.”

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