GE HealthCare announces 510(k) submission for CleaRecon DL technology designed to improve image quality in the interventional suite with AI-based reconstruction

GE HealthCare (Nasdaq: GEHC) announced today the 510(k) submission to the U.S. Food and Drug Administration for CleaRecon DL, deep learning technology, designed to improve the quality of cone-beam computed tomography (CBCT) images by bringing artificial intelligence (AI)-based 3D reconstruction to the interventional suite. This technology, which is pending 510(k) clearance, will be demonstrated at the Radiological Society of North America’s (RSNA) 2024 Annual Meeting taking place from December 1-4 in Chicago.

As demand for minimally invasive procedures continues to grow, GE HealthCare is committed to helping clinicians use image guidance technologies to their full potential by removing barriers with the goal of helping providers achieve better clinical and operational outcomes.

To be available on Allia™ Image-Guided Solutions (IGS) Systems, CleaRecon DL is designed to use AI-based reconstruction to improve image quality by removing streaks without introducing additional artifacts. It is also designed to improve CBCT analysis through clear images. This technology aims to advance the company’s vision to accelerate CBCT adoption in daily practice.

"GE HealthCare has been a leader in CBCT for more than two decades - offering continued innovation through offerings such as augmented guidance solutions designed to improve procedure outcomes, as well as developing a wide-bore platform capable of acquiring CBCT with obese patients, even with their arms down,” said Arnaud Marie, General Manager, Global Intervention at GE HealthCare. "Over the years, artifacts created in scans through natural movement of the body and the distribution of contrast have posed another significant challenge to clinicians when obtaining CBCT images - posing a major barrier to adoption of CBCT technology. We designed CleaRecon DL to address this challenge so physicians and their patients can benefit from this advanced imaging technology.”

In addition to CleaRecon DL, GE HealthCare is also introducing OnWatch Predict, predictive monitoring of interventional image-guided systems to provide enhanced service and increase system availability for on-time diagnosis, invasive procedures and treatments. Combining ongoing system diagnosis with user interface monitoring, image chain health and X-ray generation, OnWatch Predict is designed to forecast component failure, allowing clinicians to schedule service before an issue occurs with the system and limiting unplanned downtime.

For more information on GE HealthCare’s Allia IGS platform and the company’s commitment to advancing the practice of image guided therapy with artificial intelligence and digitization tools, visit GE HealthCare Booth #7330, RSNA 2024 press kit, or the RSNA 2024 events page.

*CleaRecon DL^1,2
1) Designed to be used with Allia™ systems.
2) CleaRecon DL is an option using deep learning in 3DXR. 510(k) and CE mark pending. Not available for sale in US or EU.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

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