EOS Imaging Receives FDA 510(k) Clearance for EOSedge System, Advancing Precision 3D Imaging in Orthopedic Surgery

VCBeat (WeChat ID: vcbeat) has learned that on November 29, 2019, EOS Imaging (Euronext Paris: EOSI) announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance, allowing its next-generation imaging system, EOSedge, to be commercialized in the United States.

Earlier this week, EOS Imaging announced that the EOSedge system has been launched in Europe, Canada, and Australia, and will be showcased at the upcoming Radiological Society of North America (RSNA) annual meeting in Chicago on December 1.

EOS Imaging, founded in 1989 and headquartered in Paris, France, is a global medical technology company dedicated to designing, developing, and marketing innovative, low-dose, full-body 2D and 3D imaging solutions with practical functionality, high-efficiency 3D modeling services, and surgical planning software, contributing to improved patient outcomes.

EOS Imaging is a leading provider of 2D/3D imaging and data solutions for orthopedics, with its offerings supporting the entire care pathway—from preoperative imaging for hip, knee, and spinal surgeries to postoperative assessment. The first EOS systems were installed in Europe and North America in 2008, and EOS Imaging was listed on the Euronext Paris stock exchange in 2012. Currently, the EOS platform is available in 51 countries and regions worldwide, including the United States, Japan, China, and the European Union. The company operates five subsidiaries located in Besançon, France; Cambridge, USA; Montreal, Canada; Frankfurt, Germany; and Singapore.

The company possesses the first X-ray imaging system equipped with photon-counting technology, delivering high-resolution images for musculoskeletal X-ray examinations. EOSedge utilizes the new Flex Dose technology, which adjusts and optimizes radiation dose during patient body scanning. The new open gantry features a motorized, spacious platform that facilitates easier access to a larger acquisition area for a broader range of patients.

EOSedge enhances EOS Imaging’s product portfolio, offering this system as an imaging platform to the company’s customers. Both EOSedge and other EOS products are designed for 3D modeling that integrates with surgical solutions from Advanced Orthopedics companies. Its solutions are categorized into: EOS System (low-dose imaging system), SterEOS (3D modeling workstation), and EOSapps (3D surgical planning).

Mike Lobinsky, CEO of EOS Imaging, stated, “The FDA’s 510(k) clearance for EOSedge represents a pivotal step toward the global commercialization of this new system. Following its launches in Europe, Canada, and Australia, we are now poised to serve the U.S. market and deliver the latest major innovation in orthopedic imaging to clinicians and patients in these key markets.”

(Compiled by: Jiang Ying)