GE HealthCare Submits 510(k) for AI-Powered CleaRecon DL Imaging Tech

GE HealthCare has announced the submission of its 510(k) application to the U.S. Food and Drug Administration (FDA) for CleaRecon DL, an innovative deep learning technology designed to enhance the quality of cone-beam computed tomography (CBCT) imaging. By incorporating artificial intelligence (AI)-based 3D reconstruction into the interventional suite, CleaRecon DL aims to address long-standing imaging challenges, making CBCT more effective for clinicians. The technology, currently pending FDA clearance, will be showcased at the Radiological Society of North America (RSNA) 2024 Annual Meeting in Chicago, running from December 1-4.

Transforming Imaging in the Interventional Suite

The growing demand for minimally invasive procedures has placed greater emphasis on advanced imaging technologies to support precision and efficiency. GE HealthCare’s CleaRecon DL represents a significant step toward overcoming barriers that have historically limited the adoption of CBCT in routine practice.

To be integrated into the Allia™ Image-Guided Solutions (IGS) Systems, CleaRecon DL is specifically designed to utilize AI-based algorithms to enhance image quality by eliminating streaks and reducing artifacts, a common challenge in CBCT imaging. This improvement ensures clearer visualization, enabling clinicians to perform detailed analyses and make more informed decisions during procedures.

The technology aligns with GE HealthCare’s broader vision of driving innovation in image-guided therapy. By introducing cutting-edge tools, the company seeks to empower clinicians with the resources needed to improve both clinical outcomes and operational efficiency.

Addressing Long-Standing Challenges in CBCT

Arnaud Marie, General Manager of Global Intervention at GE HealthCare, emphasized the company’s leadership in CBCT innovation over the past two decades. “GE HealthCare has consistently delivered breakthroughs, from augmented guidance solutions that improve procedure outcomes to developing a wide-bore platform capable of acquiring CBCT images for obese patients, even with their arms down,” said Marie.

One of the persistent challenges in CBCT imaging has been the artifacts caused by natural body movement and contrast distribution during scans. These artifacts often limit the utility of CBCT technology, creating hurdles for adoption in clinical practice. CleaRecon DL was specifically designed to address these issues, enhancing the clarity and usability of CBCT images.

“Our goal with CleaRecon DL is to remove these barriers so clinicians and their patients can fully benefit from this advanced imaging technology,” Marie added.

Introducing OnWatch Predict: A Complementary Innovation

In addition to CleaRecon DL, GE HealthCare is unveiling another significant advancement: OnWatch Predict. This predictive monitoring system enhances the reliability and availability of interventional image-guided systems. OnWatch Predict combines real-time system diagnostics with monitoring of key components such as the user interface, image chain health, and X-ray generation.

By forecasting potential component failures, OnWatch Predict enables proactive maintenance, allowing clinicians to schedule service before disruptions occur. This capability minimizes unplanned downtime, ensuring systems are ready for timely diagnoses, invasive procedures, and treatments.

Showcasing Innovation at RSNA 2024

GE HealthCare’s latest advancements, including CleaRecon DL and OnWatch Predict, will be prominently featured at the RSNA 2024 Annual Meeting. Attendees can explore these innovations at GE HealthCare’s booth (#7330) or through the event’s dedicated press kit and digital resources.

The company’s ongoing commitment to advancing image-guided therapy is reflected in its integration of artificial intelligence and digitization tools into its solutions. These technologies not only improve the precision of procedures but also contribute to the broader transformation of healthcare delivery by enhancing efficiency and reliability.

For more information on GE HealthCare’s Allia IGS platform and its suite of innovative solutions, visit the GE HealthCare website or connect with representatives at RSNA 2024.

By addressing key challenges in imaging quality and system reliability, GE HealthCare continues to push the boundaries of what’s possible in interventional medicine, paving the way for improved patient outcomes and streamlined clinical workflows.

Source Link

Newsletter Updates

Enter your email address below and subscribe to our newsletter