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FDA approves new imaging software for hip arthroplasty
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EOS Imaging has received 510(k) clearance from the FDA for its next-generation sterEOS 3D imaging software.
According to a company press release, the sterEOS software provides 3-D modeling of the spine and lower limb based on scans taken with the EOS System, and automatically calculates more than 100 clinical parameters relevant to diagnosis and surgical planning. With new capabilities to measure hip implant component position for surgery control and revision, the software offers expanded calculation and analysis, as well as 3-D modeling of severe scoliosis. The software will be available to existing EOS customers as a software upgrade and will be included in all new system sales.
“This introduction of hip arthroplasty postoperative 3-D imaging to the EOS System answers growing challenges in orthopedic surgery postop evaluation. It also provides the first weightbearing 3-D solution to enhance the understanding and, ultimately, treatment of total hip replacement complications such as dislocations and wear,” Marie Meynadier, chief executive officer of EOS Imaging, stated in the release.