The US Food and Drug Administration (FDA) has granted 510(k) clearance to EOS imaging's new sterEOS 3D imaging software.
The sterEOS 1.5 software, which is part of the company's full body, low-dose 3 D EOS imaging system, features new capabilities to measure hip implant component position for surgery control and revision as well as provide 3D modelling of severe scoliosis (Cobb angle above 50°).
The software provides 3D modelling of the spine and lower limb based on the scans taken with the imaging system and automatically calculates over 100 clinical parameters relevant to diagnosis and surgical planning.
EOS imaging CEO Marie Meynadier said the introduction of hip arthroplasty post-operative 3D imaging to the EOS System answers challenges in orthopedic surgery post-op assessment.
"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," Meynadier added.
"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."
According to the company, the imaging system delivers radiation dose nine times lower than that of computed radiography X-ray1 and 20 times lower than basic CT scans.
