Eos Imaging wins FDA nod for spineEos 3D planning solution

EOS Imaging (EPA:EOSI) said it won pre-market approval from the FDA for its spineEos 3D planning software for spinal surgeries. Paris-based Eos won CE Mark approval in the European Union in February for the system, which is designed to use 3D imaging to create optimized treatment plans for pediatric patients with scoliosis and adults with spine conditions. “We believe that patients’ spines are complex 3D systems that need a personalized 3D planning of the intended surgery. We’re excited about the interest we’ve seen in our spineEOS planning software from surgeons inside and outside of our current installed base, as well as from our industry partners. We look forward to this next important step toward our broader goal of expanding our EOSapps planning software suite to better connect imaging to patient care,” CEO Marie Meynadier said in prepared remarks. In December 2015, Eos reported results from a a clinical study examining the association of sagittal balance measurements and risk of falling in elderly patients, showing a correlation between falling risk and postural balance measured using its sterEos workstation. The post Eos Imaging wins FDA nod for spineEos 3D planning solution appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Imaging Regulatory/Compliance Spinal Eos Imaging Source Type: news