FDA has given 510(k) clearance to EOS Imaging’s 3D planning software for total knee arthroplasties. The green light continues the run of regulatory successes for EOS, which has now secured the OK to sell its full suite of EOSapps in the U.S.
KneeEOS, the latest app to receive FDA clearance, is the last step in a process that turns front and side-on images from a system sold by EOS into 3D models surgeons can use to plan knee operations. The 3D models generated by EOS’ team and rendered in kneeEOS allow surgeons to choose the size of implant needed for an operation and assess its positioning before starting a procedure. KneeEOS suggests the most appropriate implant and position based on the model.
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