Healthcare Industry News:  total hip replacement 

Devices Radiology Orthopaedic FDA

 News Release - March 19, 2013

EOS imaging Receives FDA Clearance for 3D Imaging Software featuring Post-operative Hip Implant Assessment

EOS® 3D Orthopedic Imaging System with sterEOS® 1.5 to be Featured at AAOS 2013 Annual Meeting

CAMBRIDGE, Mass. & PARIS--(Healthcare Sales & Marketing Network)--EOS imaging (NYSE Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that its next-generation sterEOS® 3D imaging software, sterEOS® 1.5, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The sterEOS® 1.5 software will be highlighted along with the full EOS® Imaging System at the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 19-23 in Chicago, IL, at the EOS booth. The technology is also featured in a paper submitted for the Hip Society Awards, which will be presented on Saturday, March 23.

The sterEOS® software provides 3D modelling of the spine and lower limb based on scans taken with the EOS® System, and automatically calculates over 100 clinical parameters relevant to diagnosis and surgical planning. The new sterEOS® 1.5 offers expanded calculation and analysis, with new capabilities to measure hip implant component position for surgery control and revision. Other key features include 3D modelling of severe scoliosis (Cobb angle above 50°). It will be made available to existing EOS customers as a software upgrade and will be included in all new system sales.

Marie Meynadier, CEO of EOS imaging, said, “The introduction of hip arthroplasty post-operative 3D imaging to the EOS System answers growing challenges in orthopedic surgery post-op evaluation. It also provides the first weight-bearing 3D solution to enhance the understanding and, ultimately, treatment of total hip replacement complications such as dislocations and wear. Ongoing research supports the unique value of EOS in understanding the relation between implant position, pelvic mobility and patient function, therefore improving treatment and patient outcomes in joint arthroplasty.”

One of the first clinical applications of the new features in assessing and monitoring hip implant alignment is discussed in a paper under consideration for the Hip Society Awards, authored by Ian Clarke, PhD, of Loma Linda University in Loma Linda, CA and Jean-Yves Lazennec, MD, of La Pitié Salpétrière Hospital in Paris, France. The study, titled “Impingement and Abrasion Risks with MOM Bearings,” reviews how metal-on-metal hip prosthesis wear is related to implant component orientation.

EOS is the first full body, low-dose 3D imaging system, delivering a radiation dose nine times lower than that of computed radiography X-ray1 and 20 times lower than basic CT scans2. For more information on the Company and its technology, visit or stop by the EOS booth #4233 at the AAOS meeting.

About EOS imaging:

The EOS imaging group designs, develops and markets EOS®, a revolutionary and patented medical imaging system, based on technology that enabled George Charpak to win the Nobel Prize for Physics. The Group has obtained authorization to market the system in 30 countries, including the United States (FDA), Canada, Australia and the European Union (EU). With an installed base of 60 sites and more than 350,000 imaging sessions, EOS® benefits from worldwide recognition and established credibility within the medical community. The Group currently employs 63 people, including an R&D team of 23 engineers, and recorded consolidated revenue of €9.41 million in 2012. The Group's head office is based in Paris, with a subsidiary in the United States in Cambridge (Massachusetts), as well as in Montreal (Canada) and Germany. For further information, please go to:

EOS imaging is listed on Compartment C of the NYSE Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

1 S. Parent et al. “Diagnostic imaging of spinal deformities: Reducing patients radiation dose with a new slot-scanning x-ray imager.” Spine. April 2010, 35 (9): 989

2 Rapport DRPH/SER n°2010-08 – IRSN (Institut de Radioprotection et de Sûreté Nucléaire)

Source: EOS imaging

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