EOS imaging has received 510(k) clearance from the FDA for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the recent commercial launch of EOSedge in Europe, Canada and Australia. A press release reports that 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.
According to the press release, EOSedge features new Flex Dose technology to modulate radiation dose along the patient’s body, as well as an open cabin with a motorised, enlarged patient platform to facilitate easy and comfortable access for a broad range of patients to deliver larger fields of examination. 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, CEOof EOS imaging, comments: “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 orthopaedic imaging to clinicians and patients in these key markets.”