FDA OKs GE Healthcare’s New 3D Surgical Imaging System

GE Healthcare obtained 510(k) clearance from U.S. FDA for OEC 3D, a surgical imaging system capable of 3D and 2D imaging. OEC 3D aims to set a standard for interoperative 3D imaging with precise volumetric images for spine and orthopedic procedures. This new system combines the benefits and familiarity of 2D imaging with greater efficiency to increase access and usability to 3D.
 
“We’re thrilled to introduce OEC 3D to clinicians who want amazing 3D volumetric images quickly during intraoperative procedures,” Gustavo Perez Fernandez, president and CEO of GE Healthcare Image Guided Therapies told the press. “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 C-arm recently completed clinical evaluations in vivo and in simulated laboratory procedures. Clinicians commented on the excellent image quality of the 3D volumes stating they were similar to what’s expected from a CT scan. Additionally, the simplicity of performing 3D and 2D imaging on OEC 3D was noted as an improvement versus current methods. In a recent study¹, during a procedure with a 3D C-arm, users noted a second 2D C-arm is also used 70 percent of the time due to ease of use and familiarity.
 
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.
 
OEC 3D includes the recognizable 2D imaging experience of OEC C-arms for imaging versatility from general surgery to interventional cardiovascular procedures, delivering a familiar user experience with the added benefit to quickly capture a 3D scan.
 
References
¹ 3D Mobile C-arm Utilization Study in the United States, November 2020, conducted by Cetas Healthcare for GE Healthcare