EOS imaging receives FDA clearance for 3D imaging software

EOS imaging, the pioneer in 2D/3D orthopedic medical imaging, announced that its next-generation sterEOS3D imaging software, sterEOS 1.5, has received 510(k) clearance from the US Food and Drug Administration (FDA).

The sterEOS software provides 3D modelling of the spine and lower limb based on scans taken with the EOS System, and automatically calculates over 100 clinical parameters relevant to diagnosis and surgical planning. The new sterEOS 1.5 offers expanded calculation and analysis, with new capabilities to measure hip implant component position for surgery control and revision. Other key features include 3D modelling of severe scoliosis (Cobb angle above 50°). It will be made available to existing EOS customers as a software upgrade and will be included in all new system sales.

Marie Meynadier, CEO, EOSimaging, said,“The introduction of hip arthroplasty post-operative 3D imaging to the EOS System answers growing challenges in orthopedic surgery post-op evaluation. It also provides the first weight-bearing 3D solution to enhance the understanding and, ultimately,treatment of total hip replacement complications such as dislocations and wear. Ongoing research supports the unique value of EOS in understanding the relation between implant position, pelvic mobility and patient function,therefore improving treatment and patient outcomes in joint arthroplasty.”

EH News Bureau

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