EOS Imaging receives FDA 510(k) clearance to market 3-D planning software for TKA
EOS Imaging announced it received FDA 510(k) clearance to market its kneeEOS software in the United States.
According to a company release, the online 3-D planning software uses weight-bearing 3-D images and data from EOS system to allow for surgical planning for total knee arthroplasty. The kneeEOS reportedly makes an initial automatic proposal for component size and position. The software also optimizes alignment in 3-D and displays real-time clinical parameters.
“The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market,” Marie Meynadier, chief executive officer of EOS Imaging, said in the release. “It will support the growing adoption of EOS images, 3-D models and patient-specific datasets at each step of the care continuum, helping health care providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”
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