EOS Imaging’s Hip Implant Assessment 3D Software Wins FDA Nod
EOS Imaging’s next-generation sterEOS 1.5 3D imaging software has been granted FDA 510(k) clearance, the French devicemaker announced last week.
The device uses EOS system scans to 3D model the spine and lower limb, and includes expanded calculation and analysis parameters, with an additional new hip implant feature. It can also create a model for severe scoliosis. The upgraded software will come as part of all new system sales, the company says.
EOS imaging software is the first full body, low-dose 3D imaging system, the devicemaker claims. It administers radiation doses nine times lower than computed radiography X-rays and 20 times lower than CT scans.
In addition to the U.S., the system is available in 30 countries, including Canada, Europe and Australia. — Jason Scott