EOS imaging has secured 510(k) clearance from the Food and Drug Administration (FDA) for knee EOS 3D surgical planning software for total knee arthroplasty.
The software uses weight-bearing 3D images and data from the EOS system to offer an advanced surgical plan for total knee arthroplasty.
It offers an initial automatic proposal for the size selection and position of the implant components to help surgical preparation and enhance the alignment in 3D while displaying relevant clinical parameters in real time.
EOSapp are based on a patient’s 2D images and 3D digital anatomical dataset secured from EOS exam.
EOS exams are carried out through various steps, including diagnosis, pre-operative planning, post-operative assessment and follow-up.
EOS imaging CEO Marie Meynadier said: “The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market.
“It will support the growing adoption of EOS images, 3D models and patient-specific datasets at each step of the care continuum, helping healthcare providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”
In April, EOS imaging also received FDA approval spineEOS online 3D planning software for spine surgery.
Based on EOS stereo-radiographic 2D/3D imaging, the new 3D planning software enables to treat adults suffering from degenerative or deformative spine conditions, as well as pediatric patients with adolescent idiopathic scoliosis.
EOS medical imaging system is used in osteoarticular pathologies and orthopaedics, as well as associated solutions.
It was approved to market in 51 countries, including the US, Japan, China, and the European Union (EC).
Image: EOS imaging has received FDA approval for kneeEOS software. Photo: courtesy of Stuart Miles / FreeDigitalPhotos.net.