GE HealthCare Submits 510(k) for CleaRecon DL AI-Based Image Quality Tech

GE HealthCare (Nasdaq: GEHC) has announced the 510(k) submission for CleaRecon DL, a deep learning technology aimed at enhancing the quality of cone-beam computed tomography (CBCT) images. This AI-powered 3D reconstruction technology is designed for use in the interventional suite to improve imaging quality. Currently pending 510(k) clearance, CleaRecon DL will be showcased at the Radiological Society of North America’s (RSNA) 2024 Annual Meeting, held in Chicago from December 1-4.

As the demand for minimally invasive procedures continues to rise, GE HealthCare is dedicated to helping clinicians fully utilize image guidance technologies, aiming to eliminate barriers that hinder better clinical and operational outcomes.

The CleaRecon DL technology, designed for Allia™ Image-Guided Solutions (IGS) Systems, uses AI-based 3D reconstruction to improve cone-beam computed tomography (CBCT) image quality. It enhances images by removing streaks without introducing additional artifacts, offering clearer images for better CBCT analysis. This technology aligns with GE HealthCare’s vision of accelerating CBCT adoption in routine medical practice.

“GE HealthCare has led the way in CBCT for over 20 years, innovating with solutions like augmented guidance to improve procedure outcomes and a wide-bore platform that can capture CBCT images even for obese patients with their arms down,” said Arnaud Marie, General Manager of Global Intervention at GE HealthCare. He continued, “Over the years, challenges such as artifacts caused by natural body movement and contrast distribution have hindered clinicians’ ability to obtain clear CBCT images. CleaRecon DL was designed to address these challenges and help both physicians and patients benefit from advanced imaging technology.”

In addition to CleaRecon DL, GE HealthCare is introducing OnWatch Predict, a predictive monitoring system for interventional image-guided systems. This service tool aims to enhance system availability, enabling timely diagnoses, procedures, and treatments. By combining system diagnostics, user interface monitoring, image chain health, and X-ray generation, OnWatch Predict can forecast potential component failures. This allows clinicians to schedule preventive service before any issues arise, reducing unplanned downtime and ensuring systems are operational when needed most.

GE HealthCare’s Allia IGS platform and its commitment to advancing image-guided therapy through artificial intelligence and digital tools will be highlighted at RSNA 2024. To learn more, visit GE HealthCare’s Booth #7330 during the event or explore the RSNA 2024 press kit and events page.

*CleaRecon DL is an option using deep learning in 3DXR and is designed for Allia™ systems. 510(k) and CE mark pending. Not available for sale in the US or EU.

About GE HealthCare Technologies Inc.
GE HealthCare is a global leader in medical technology, pharmaceutical diagnostics, and digital solutions, dedicated to improving the efficiency of hospitals, the effectiveness of clinicians, the precision of therapies, and the overall health and happiness of patients. With over 125 years of experience, GE HealthCare focuses on advancing personalized, connected care. The company’s imaging, advanced visualization, patient care solutions, and pharmaceutical diagnostics businesses help improve patient outcomes from diagnosis through therapy and monitoring. GE HealthCare is a $19.6 billion business with approximately 51,000 employees worldwide, working toward a future where healthcare has no limits.

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