FDA clears EOS orthopedic imaging system for use in lower limbs applications

EOS imaging (www.eos-imaging.com) announced today that it has received FDA clearance of its sterEOS 3D orthopedic imaging workstation for use in lower limbs applications for patients 15 years and older.

For decades, radiologists, orthopaedic surgeons and rheumatologists have had to rely on a set of 2D x-ray images to help them imagine what a 3D skeletal image of their patient would look like. Now, the EOS workstation sterEOS can create a 3D rendering of a patient's skeletal anatomy within seconds. With highly accurate clinical parameters, sterEOS delivers a large size 3D weight-bearing image at an irradiation level that is more than 100 times lower than that of a 3D CT scan, designed to enable superior pre- and post-op surgical planning.

"We are very pleased with this additional FDA clearance, as it will further fuel the market penetration momentum that we are achieving in the United States for our ultra-low-radiation-dose EOS orthopedic imaging system," said Hervé Legrand, VP Sales & Marketing North America for EOS imaging. "Some of the most prestigious orthopedic centers in the world, such as Barnes-Jewish Hospital (St. Louis, Mo.), New York University (NY), and the University of Iowa (Iowa City), have recently adopted EOS and sterEOS for their musculoskeletal imaging suites.

"This clearance is a great step forward for us as it is now allowing orthopedic surgeons specialized in lower limb disorders to have access to our unique technology. For the first time, orthopedists can retrieve patients' highly accurate clinical parameters of the femur and the tibia in a weight-bearing position that will ensure optimal pre-operative and post-operative planning. This has not been possible until now," added Mr. Legrand. "These breakthrough features underscore why EOS is evolving as an entirely new modality in orthopedic imaging, with extremely low x-ray exposure to the patient — and efficient patient workflow for the physician," said Mr. Legrand.