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

Related Content

Rayence Demonstrates Full Digital Imaging Product Line at RSNA 2017
News | Digital Radiography (DR) | January 16, 2018
January 16, 2018 — Rayence recently showcased their entire line of new as well as enhanced digital imaging products a
Fat Distribution in Women and Men Provides Clues to Heart Attack Risk
News | Women's Health | January 11, 2018
January 11, 2018 – It’s not the amount of fat in your body but where it is stored that may increase your risk for hea
Emergency Radiologists See Inner Toll of Opioid Use Disorders

Rates of Imaging Positivity for IV-SUDs Complications. Image courtesy of Efren J. Flores, M.D.

News | Clinical Study | January 11, 2018
January 11, 2018 – Emergency radiologists are seeing a high prevalence of patients with complications related to opio
Hip Steroid Injections Associated with Bone Changes

58-year-old woman with left hip pain. X-ray from one month prior to the steroid/anesthetic injection demonstrates moderate joint space narrowing (arrows) and bony proliferation (arrowheads).

News | Orthopedic Imaging | January 11, 2018
January 11, 2018 – Osteoarthritis patients who received a steroid injection in the hip had a significantly greater in
Radiology Offers Clues in Cases of Domestic Abuse and Sexual Assault

Image of 21-year-old woman, who presented with a chronic nasal bone fracture and soft tissue swelling of the left lateral face. Review of electronic medical records revealed presentation to an outside hospital 9 months ago with oblique fracture of the right ring finger proximal phalanx, blowout fracture of the medial wall of the left orbit and similar soft tissue swelling of the left face. Traumatic findings separated in time suggest recurrent violence. Image courtesy of Elizabeth George, M.D.

News | Orthopedic Imaging | January 08, 2018
Radiologic signs of injury could help identify victims of intimate partner violence, according to a study presented at...
New Thales Pixium Portable 3543 DR Features Embedded Patient Identification
Technology | Digital Radiography (DR) | December 28, 2017
December 28, 2017 — At the 2017 Radiological Society of North America (RSNA) Annual Meeting, Nov. 26-Dec.
FDA Issues Final Guidance on Pediatric X-ray Imaging Device Notifications
News | Pediatric Imaging | December 21, 2017
The U.S. Food and Drug Administration (FDA) published a final guidance document entitled “Pediatric Information for X-...
Kubtec Supplies Imaging Equipment for Excavation of 3,500-Year-Old Greek Tomb
News | Digital Radiography (DR) | December 07, 2017
Kubtec announced it has been selected to supply high-resolution X-ray imaging equipment to the international research...
Canon Showcases New CXDI Digital Radiography Detectors at RSNA 2017
News | Digital Radiography (DR) | December 06, 2017
Canon U.S.A. Inc. and Virtual Imaging Inc. recently announced the launch of the CXDI-710C, CXDI-810C and CXDI-410C...
Fujifilm Introduces FDR Go Plus Version Portable DR System at RSNA 2017
Technology | Digital Radiography (DR) | November 28, 2017
November 28, 2017 — Fujifilm Medical Systems U.S.A. Inc.
Overlay Init