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).
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.
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.
The system will also serve as pre-operative software for simulating/evaluating surgical treatment options.
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.
“Having these certifications means that we can use the software for clinical applications like pre-surgical planning. This helps us incorporate ScanIP into vital areas of patient-specific implant design and simulation.”
Simpleware software allows to convert 3D scan data into high-quality computer models for use in engineering design and simulation applications.
Simpleware products can be used in a range of product design and data analysis applications, including life sciences, consumer products, aerospace, automotive, defence, oil, and gas industries.
Synopsys TCAD engineering vice president Terry Ma said: “ScanIP Medical, together with CE marking and FDA 510(k) clearance, shows great potential for expanding Synopsys’ role in software applications for the medical simulation and pre-surgical planning market across the United States and Europe.
“Together with ISO certification, it further enhances Synopsys’ ability to provide high-quality medical software that can consistently meet customer needs and applicable regulatory requirements.”
Synopsys is said to be the Silicon to Software partner for companies developing the electronic products and software applications.
The company is specialized in providing electronic design automation (EDA) and semiconductor IP products. It also offers software security and quality solutions to the customers, including system-on-chip (SoC) designer creating advanced semiconductors and software developer writing applications with security and quality.