EOS Imaging Receives FDA 510(K) Clearance for kneeEOS 3D Surgical Planning Software
EOS imaging received FDA 510(k) clearance to market kneeEOS, online planning software that uses weight-bearing 3D images and data to plan Total Knee Arthroplasty. The clearance completes the portfolio of EOSapps dedicated to the most common orthopaedic surgeries.
EOS' software solutions are also cleared by regulatory bodies in Brazil, the EU, Japan, Korea, etc.
EOSapps are based on a patient’s 2D images and 3D digital anatomical dataset obtained from EOS exams, which are performed throughout the care path including diagnosis, pre-op planning, post-op assessment and follow-up.
The software makes an initial automatic proposal for implant size selection and position to support surgical preparation and to optimize alignment in 3D, while displaying relevant clinical parameters in real time.
Sources: EOS Imaging; ORTHOWORLD Inc.