News | October 06, 2008

FDA Clears Low-Dose 3D X-ray for Orthopedic Imaging

October 7, 2008 — Biospace Med reported it has received 510(k) clearance from the FDA to market the company’s EOS X-ray imager along with its new image workstation, sterEOS, which enables 3D skeletal reconstruction.

EOS is designed for clinical indications such as spine pathologies and hip and knee arthropathies, where a weight-bearing assessment is necessary to ensure optimal treatment. EOS can capture head-to-toe images of patients in a standing, weight-bearing position with a dramatic reduction in radiation dosage—up to 10 times less than a conventional x-ray and up to 1000 times less than a CT (Computed Tomography) scan. Additionally, the new sterEOS 3D reconstruction and measurement workstation is designed to reduce surgical planning time and help establish the most effective course of treatment.

According to Jean-Charles LeHuec, M.D., Ph.D, Bordeaux Spine Center, Pellegrin University Hospital, Bordeaux, France, “EOS is especially helpful in any situation where patients want to limit their exposure to radiation, and also in situations where long-length, weight-bearing images are needed. The full-length, weight-bearing imaging capabilities of EOS are able to provide physicians with a global assessment of balance and posture and now, with 3D, an assessment of the relative positioning of each vertebra, thereby enabling better preoperative assessment.”

Currently, the only possibility for 3D planning for orthopedic surgery is a CT (Computed Tomography) scan, which is not reflective of a weight-bearing, functional position of the spine. Using diagnostic images made in the supine (lying down) position leads to significant changes in relative position of the bones and joints to one another, and ultimately changes the clinical parameters and measurements that are made for preoperative planning purposes, making them potentially inexact.

For more information: www.biospacemed.com

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