Business Wire12.02.19
EOS imaging 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 in Chicago.
Mike Lobinsky, CEO 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.”
EOSedge is a 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 access for a broad range of patients to deliver larger fields of examination.
EOSedge will expand 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 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, CEO 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.”
EOSedge is a 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 access for a broad range of patients to deliver larger fields of examination.
EOSedge will expand 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 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.