FDA Clears C-Arm Designed for Routine 3D Imaging

By News Release

GE Healthcare announced US FDA clearance for OEC 3D, a new surgical imaging system capable of interoperative 3D and 2D imaging with precise volumetric images for spine and orthopedic procedures.

Developed in collaboration with healthcare professionals and institutions around the world, OEC 3D C-arm recently completed clinical evaluations in vivo and in simulated laboratory procedures. Clinicians involved commented on the excellent image quality of the 3D volumes stating they were similar to what they expect from a CT scan. Additionally, the simplicity of performing both 3D as well as 2D imaging on OEC 3D was noted as an improvement versus current methods.

In a recent study conducted by Cetas Healthcare for GE, during a procedure with a 3D C-arm, users noted that a second 2D C-arm is also used 70 percent of the time due to ease of use and familiarity. The OEC 3D C-arm enables users to enjoy the benefits of both 3D and 2D imaging in one easy-to-use system.

“We’re thrilled to introduce OEC 3D to clinicians who want amazing 3D volumetric images quickly during intraoperative procedures,” said Gustavo Perez Fernandez, president and CEO of GE Healthcare Image Guided Therapies. “Built on the successful OEC Elite C-arm platform, the familiar performance and functionality of the OEC 3D C-arm will make 3D imaging routine for complex spine and joint replacement procedures.”

OEC 3D provides a large 19 cm x 19 cm x 19 cm field of view with high resolution and detail. An advanced reconstruction engine quickly presents images on an intuitive Volume Viewer with advanced tools and analysis for surgical assessment. In addition, OEC 3D is open to interface with advanced intraoperative technologies such as navigation and robotics.  

For improved asset utilization, OEC 3D includes the recognizable 2D imaging experience of OEC C-arms for imaging versatility from general surgery to interventional cardio-vascular procedures, delivering a familiar user experience with the added benefit to quickly capture a 3D scan.

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FDA Clears C-Arm Designed for Routine 3D Imaging.  Appl Radiol. 

By News Release| March 23, 2021

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