Synopsys Simpleware ScanIP Medical wins FDA 510(k) and CE-Mark clearances

(Image from Synopsys)

Synopsys (NSDQ:SNPS) has updated its Simpleware ScanIP 3D image processing software offering to include medical use. Simpleware ScanIP Medical recently received CE-marking as a medical device following FDA 510(k) clearance in the United States.

Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner, such as a CT or MRI scanner, to an output file. The software is also intended as pre-operative software for simulating/evaluating surgical treatment options.

The software is developed using an ISO 13485:2016-certified quality management system. Synopsys said Simpleware ScanIP Medical will allow users to:

• Import and anonymize patient DICOM tags from a PACS server (DICOM 3.0 compliant).
• Combine CAD and imaging data for patient-specific analysis.
• Rapidly segment and process medical images with an easy-to-use interface.
• Obtain reliable data for complex anatomical analysis using measurement and statistics tools.
• Export geometrically accurate models for pre-surgical planning.

ScanIP Medical is compliant with patient data privacy standards, according to Synopsys. It can be used in a medtech company’s R&D workstation, a hospital or clinic radiology department, or other clinical work environments.

“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,” said Terry Ma, Synopsys’ vice president of engineering for TCAD, in a prepared statement. “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.”

“ScanIP Medical receiving CE marking and FDA (510k) clearance is an important landmark,” added orthopedic surgeon Johann Henckel of University College London and the Royal National Orthopaedic Hospital. “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.”