![]() ![]() “Having these certifications means that we can use the software for clinical applications like pre-surgical planning. The Royal National Orthopaedic Hospital and University College London orthopedic surgeon Johann Henckel said: “ScanIP Medical receiving CE marking and FDA ( 510K) clearance is an important landmark. The system will also serve as pre-operative software for simulating/evaluating surgical treatment options. Simpleware ScanIP Medical was developed by using an ISO 13485:2016 quality management system, and it enables medical device design and patient-specific analysis companies to create models by using 3D imaging data. Simpleware ScanIP Medical has been designed to be used as a software interface and image segmentation system to transfer imaging information from a medical scanner, including a computerized tomography (CT) scanner or magnetic resonance imaging (MRI) scanner, to an output file. ![]() Image: Synopsys has introduced Simpleware ScanIP Medical for medical simulation and pre-surgical planning markets. Synopsys has introduced Simpleware ScanIP Medical, which secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark approval in the European Economic Area (EEA).
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