PARIS--(BUSINESS WIRE)--Regulatory News:
EOS imaging (Paris:EOSI) (Euronext, FR0011191766 - EOSI - Eligible PEA - PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its hipEOS 3.0 surgical planning software.
hipEOS 3.0 is the latest generation of the surgical planning software for total hip arthroplasty (THA) and is part of the EOSapps suite of online 3D surgical planning solutions (spineEOS, hipEOS, kneeEOS). The EOSapps, based on unbiased, weight-bearing EOS images and an accurate 2D/3D patient-specific data set, automatically select and best-position implants in 3D, enabling surgeons to identify patient risks and develop customized plans based on each patient’s unique 3D anatomy. Specifically, hipEOS 3.0 simulates the patient’s hip range of motion based on EOS functional standing and seated exams allowing physicians to visualize and anticipate impingement and dislocation risks based on the position of the implant components.
“The EOS platform combines efficient full body, low dose biplanar imaging with online 3D EOSapps that allow physicians to simulate, plan and control post-operative results,” said Marie Meynadier, Chief Executive Officer of EOS imaging. “In addition to providing improved tools for selecting and positioning implants, our EOSapps make it easier for surgeons to engage with and educate patients by showing their treatment plan in a user-friendly 3D environment. With this new clearance, we are thrilled to offer a solution that can help surgeons identify patients at risk, use 3D data to plan a customized treatment to mitigate these risks, and ultimately improve outcomes.”
When the hipEOS solution is utilized, the software offers an initial plan for the size and position of the implant components based on the patient’s 3D data and anatomical model. The plan can be further adjusted by the physician with immediate feedback on how changes affect relevant clinical parameters. With the patient-specific data from full body, weight-bearing 2D/3D EOS images, hipEOS can be used to anticipate and better plan for the outcome of the surgical strategy, including leg length discrepancies, femoral offset and torsion, as well as hip mobility.
About EOS imaging
EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopaedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.
For more information, please visit www.eos-imaging.com.
EOS imaging has been selected to integrate the EnterNext © PEA - PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.
EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 - Ticker: EOSI