EOS imaging Receives FDA 510(k) Clearance for kneeEOS 3D Surgical Planning Software for Total Knee Arthroplasty

November 07, 2016

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI)(Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, announced today that the Company has received a 510(k) clearance from the Food and Drug Administration (FDA) to market kneeEOS software in the United States. The kneeEOS online 3D planning software utilizes weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for Total Knee Arthroplasty. The software makes an initial automatic proposal for the size selection and position of the implant components to facilitate surgical preparation and optimize the alignment in 3D while displaying relevant clinical parameters in real time.

The clearance of kneeEOS completes the Company’s current portfolio of EOSapps dedicated to the most common orthopedic surgeries. The EOSapps are based on a patient’s 2D images and 3D digital anatomical dataset obtained from an EOS exam. EOS exams are performed at each step of the patient care continuum including diagnosis, pre-operative planning, post-operative assessment and follow-up.

Marie Meynadier, CEO of EOS imaging, said, “The kneeEOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market. It will support the growing adoption of EOS images, 3D models and patient-specific datasets at each step of the care continuum, helping healthcare providers bring the value of personalized treatments to their patients without the high dose and cost of CT imaging.”

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EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States, Japan, China, and the European Union. The Group posted 2015 revenues of €21.8 million and employs 122 people. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.


EOS imaging
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