Sat, 25-Jun-2022
Friday 29 Nov 2019 , 11:32 am

EOS Imaging Receives U.S. FDA 510(K) Clearance for EOSedge

Both EOSedge and the first-generation EOS system are designed to work seamlessly with the Advanced Orthopedic Solutions, which include 3DServices, EOSapps 3D surgical planning for spine, hip and knee as well as EOSlink, which delivers the EOS surgical plan into the operating room to be used with advanced surgical technologies.
By SIN Bureau
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EOS imaging (Euronext, FR0011191766 - EOSI - Eligible PEA - PME) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new generation imaging system, EOSedge.

Receipt of FDA 510(k) clearance follows the commercial launch of EOSedge in Europe, Canada and Australia earlier this week. The new system will be unveiled at the upcoming Radiological Society of North America (RSNA) 2019 Annual Meeting starting on December 1st, in Chicago.

EOSedge is the first general X-ray system powered by a high-resolution photon counting detector, delivering optimal image quality for outstanding musculoskeletal imaging exams. EOSedge features new Flex Dose technology to modulate radiation dose along the patient’s body, as well as an open cabin with a motorized, enlarged patient platform to facilitate easy and comfortable access for a broad range of patients to deliver larger fields of examination.

EOSedge will strengthen the portfolio of the Company, with the first-generation EOS system continuing to be part of the EOS imaging offering. Both EOSedge and the first-generation EOS system are designed to work seamlessly with the Advanced Orthopedic Solutions, which include 3DServices, EOSapps 3D surgical planning for spine, hip and knee as well as EOSlink, which delivers the EOS surgical plan into the operating room to be used with advanced surgical technologies.

Mike Lobinsky, Chief Executive Officer of EOS imaging, commented, “The FDA's 510(k) approval for EOSedge is a major milestone in the global marketing of this new system. After the launch in Europe, Canada and Australia, we are now ready to address the American market and offer the latest major innovation in orthopedic imaging to clinicians and patients in these key markets.”




Neha Mule

Neha writes articles on sectors including medicine, food, materials, and science & technology. A qualified statistician, she has the ability to observe and analyze the trends in global markets and write compelling articles that help CXOs in decision making. She is a bookworm and loves to read fiction, lifestyle, science and technology. Neha comes with 6 years of experience in content writing and editing that involves blog writing, preparation of study materials and OERs.

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