ExtremitiesRegulatory

EOS imaging Announces CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging and associated solutions, today announced the CE mark of kneeEOS, the first 3D planning software for total knee arthroplasty (TKA) based on EOS bi-planar imaging. The Company will showcase the planning suite at the 16th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, held May 27-29 in Prague.

kneeEOS is the second software offering powered by EOS images following hipEOS, which was CE Marked and FDA cleared in 2014. This 3D surgical planning platform is based on EOS’ low dose 3D images and technology from OneFit Medical, a company acquired by EOS imaging in late 2013. kneeEOS will initially be deployed as an online service to assist surgeons in patient’s leg alignment simulation in functional position, knee prosthesis selection, and placement simulation based upon 3D images generated by the EOS system.

Marie Meynadier, CEO of EOS imaging, said, “Leg alignment and component positioning are known to significantly influence surgical outcomes for total knee replacement. kneeEOS is the first and only 3D planning software for TKA in a functional weight bearing position. We are proud that our work has driven this new development and placed our Company at the leading edge of 3D surgical planning tool innovation that maximizes the potential of EOS’ technology for our surgeon users and their patients. Following the launch of hipEOS and our EOS 3D Service, kneeEOS marks the continued expansion of our cloud based services based on EOS unique images and associated patient datasets.”

The EOS® system provides full-body stereo-radiographic images of patients in functional positions, in both 2D and 3D. EOS exams require a radiation dose 50% to 85% less than Digital Radiology and 95% less than basic CT scans, as well as related software solutions. The new EOS Micro Dose option, recently cleared by the Food and Drug Administration, allows a further drastic step towards the ALARA principle (As Low As Reasonably Achievable) by bringing pediatric spine follow up exams at a dose level equivalent to a week of natural background radiation on Earth.

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