Simpleware ScanIP Medical obtains FDA 510 (k) clearance for medical 3D printing
Synopsys Simpleware ScanIP Medical is now available for medical 3D printing upon receipt FDA 510 (k) clearance in this area. With permission, the software may be used as part of end-to-end DICOM 3D printing workflows for diagnostic decision making.
Image Credit: Synopsys
Some of the benefits of Simpleware’s point-of-service (POC) 3D printing solution are as follows:
- Easy to learn and use: Intuitive interface with quick and easy access to all tools and features.
- Accurate and reliable: High quality anatomical models for practicing and planning complex surgical procedures.
- Customizable: Automate repeatable tasks and operations with scripts and plug-ins.
- Ready to Print: Direct link to bundled 3D printers guaranteed to work together.
- Fully Supported: All licenses come with full support from our team of application engineers.
- FDA, CE and ISO Certified: Exceptional software authorized for end-to-end diagnostic 3D printing.
One of the few software to have this FDA 510 (k) clearance, Simpleware ScanIP Medical is also CE and ISO 13485: 2016 certified as a medical device to work with medical imaging data. The indications for use of FDA 510 (k) are:
Simpleware ScanIP Medical is intended to be used as a software interface and an image segmentation system for transferring medical imaging information to an output file. It is also designed as preoperative software for diagnostic and surgical planning.
For these purposes, the output files can also be used for making physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications.
The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
As part of the clearance, Synopsys has partnered with 3D printing companies for a workflow, with more details available at https://www.synopsys.com/simpleware/clinical-applications/poc-3d-printing.html.
Our technology has always been cutting edge and best in class for working with 3D images and generating 3D models, and it’s great to have regulatory clearance now that includes point-of-service 3D printing. We are excited to deploy these solutions in a clinical point-of-service space and leverage our deep technical expertise to deliver much-needed solutions to existing bottlenecks in this area. “
Kerim Genc, Ph.D., Business Development Manager at Synopsys
Those interested in learning more about the solution can contact the Simpleware team at [email protected] and test it here: https://www.synopsys.com/simpleware/software/trial.html