FDA approves EOS imaging’s spineEOS 3D planning software

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The US Food and Drug Administration (FDA) has approved spineEOS, an online 3D planning software for spine surgery based on EOS stereo-radiographic 2D/3D imaging from EOS imaging. This follows CE marking, which was reported in March 2016.

The spineEOS online 3D planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for paediatric patients with adolescent idiopathic scoliosis. It is designed to allow a surgeon to create a treatment plan to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam. The planned surgery and virtual post correction 3D anatomy can be used to precisely plan for the 3D shape and length of the spinal implants. It can also be shared pre-operatively to engage the patient in the intended course of therapy, and should be accessible in the operating room through a custom planning report.

Marie Meynadier, chief executive officer of EOS imaging, says, “We believe that patients’ spines are complex 3D systems that need a personalised 3D planning of the intended surgery.”