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Home » GE HealthCare submits CleaRecon DL to FDA

GE HealthCare submits CleaRecon DL to FDA

December 3, 2024 By Sean Whooley

GE HealthCare LogoGE HealthCare (Nasdaq:GEHC) announced today that it submitted its CleaRecon DL technology for FDA 510(k) clearance.

The Chicago-based company designed CleaRecon DL, a deep-learning technology, to improve the quality of cone-beam CT (CBCT) images. It brings AI-based 3D reconstruction to the interventional suite.

GE HealthCare plans to make CleaRecon DL available on its Allia image-guided solutions systems. It utilizes AI-based reconstruction to improve image quality by removing streaks without introducing additional artifacts. The company says it also designed the solution to improve CBCT analysis through clear images

According to a news release, the technology aims to advance GE HealthCare’s vision of accelerating 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, GM, 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.”

Additionally, GE HealthCare plans to introduce its OnWatch Predict predictive monitoring of interventional image-guided systems. It provides enhanced service and increases system availability for on-time diagnosis, invasive procedures and treatments.

Filed Under: 510(k), Artificial Intelligence (AI), Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance, Software / IT Tagged With: GE Healthcare

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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