3D CBCT Imaging Technology Receives FDA Clearance for Interventional Procedures

GE HealthCare (Chicago, IL) recently announced the Food and Drug Administration (FDA) 510(k) clearance and commercial launch of CleaRecon DL, a 3-dimensional (3D) reconstruction engine using machine learning designed to improve the quality of cone-beam CT (CBCT) images obtained during interventional procedures, including neurointerventional procedures.  In a press release, GE HealthCare stated that the CleaRecon DL system, available on the Allia Image Guided Surgery Systems platform, can help reduce streak artifacts during CBCT image acquisition and enhance visualization of anatomic structures.

According to the company, the technology may provide improved visualization of soft tissue and vascular structures without added scan time or radiation exposure. Commenting on the clearance, Charles Nutting, DO, FSIR, interventional radiologist at Image Guided Therapy (Denver, CO): stated: “This advancement improves our ability to perform precise interventions, with less manipulation of the image and eliminates artifacts that have historically hindered image clarity, ultimately helping improve the care clinicians can provide to patients.”