HEALTH AND BEAUTY CLOSE-UP-10 October 2008-Biospace med Gets FDA OK for Its 3D X-Ray Orthopedic Imaging System and Workstation(C)2008 - CloseUpMedia - newsdesk@closeupmedia.com

Biospace med announced that it has received 510(k) clearance from the FDA (Food and Drug Administration) to market

In a release, the company noted that EOS is particularly well-suited 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.

"The 3D capability of EOS will be integral to the successful surgical planning of orthopedic spine procedures and, ultimately, will also be useful for hip and knee replacement surgeries," said 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.

"We believe that our ultra-low-dose EOS 3D x-ray imager may become the standard of care for indications such as spine surgery and hip and knee replacement, as well as all orthopedic therapies that require a true weight-bearing assessment in order to ensure optimal treatment," added Marie Meynadier, Ph.D., chief executive officer of Biospace med. "We expect the EOS low dose, 3D capability to become a new paradigm for safely and effectively imaging the spine, and we are looking forward to launching our new 3D capability at the upcoming NASS meeting."

Biospace med was founded on a partnership between Nobel Prize-winning physicist Georges Charpak and a team of biomedical engineers, orthopedic surgeons and radiologists who have developed a complete orthopedic imaging solution.

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