EOS imaging receives FDA 510(k) for hip, 3-D surgical planning software
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EOS imaging announced it received FDA 510(k) clearance for the hipEOS 3.0 surgical planning software, according to a company press release.
The hipEOS 3.0 is part of the EOSapps suite of 3-D online surgical planning solutions. Based on EOS functional standing and seated exams, the software reportedly stimulates patients’ hip range of motion, which offers physicians to visualize and anticipate impingement and risks of dislocation based on the position of implant components. The hipEOS 3.0 provides an initial plan for the implant component size and position based on a patient’s 3-D data and anatomical model. It can also anticipate and help physicians better plan for the surgical strategy outcomes, such as leg-length discrepancies, femoral offset and torsion and hip mobility, with the use of patient-specific data from full-body, weight-bearing 2-D or 3-D EOS images.
“The EOS platform combines efficient full-body, low-dose biplanar imaging with online 3-D EOSapps that allow physicians to simulate, plan and control postoperative results,” Marie Meynadier, CEO of EOS imaging, said in the release. “In addition to providing improved tools for selecting and positioning implants, our EOSapps make it easier for surgeons to engage with and educate patients by showing their treatment plan in a user-friendly 3-D environment. With this new clearance, we are thrilled to offer a solution that can help surgeons identify patients at risk, use 3-D data to plan a customized treatment to mitigate these risks and ultimately improve outcomes.”
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