EOS Imaging has received 501(k) clearance from the FDA for spineEOS, an online 3-D planning software for spine surgery.
An EOS exam takes 3-D head-to-toe frontal and lateral images of the patients, and a surgeon can then use the spineEOS, which takes into account the patient’s vertebra shape and position, to plan for the 3-D shape and length of the patient’s spinal implants needed for surgery.
The images from spineEOS can also be shared pre-operation to keep the patient informed on the course of treatment, and is accessible in the operating room through a custom planning report, according to the announcement.
“spineEOS allows both automated and manual virtual realignment of the pelvis and vertebrae from their 3-D shape and pre-op position in 3-D space," Marie Meynadier, CEO of EOS Imaging, told HCB News. "All key clinical parameters are displayed in real time and compared to published normality corridors," she added.
The software is based on the company’s stereo-radiographic 2-D/3-D imaging technology and is designed for adults with deteriorating or deformative spine conditions, as well as pediatric patients with adolescent idiopathic scoliosis, where the spine grows in an “S” or “C” shape.
spineEOS received CE mark
earlier this year in February, and Professor Peter Newton at Rady Children’s Hospital in San Diego, California, and Professor Brice Ilharreborde at Debré Hospital in Paris, France, are currently conducting clinical studies using spineEOS.