3D Systems Receives FDA Clearance for D2P Software

3D Systems has received additional 510(k) clearance for itsD2P (DICOM-to-PRINT) software, allowing clinicians to 3D print diagnosticpatient-specific anatomic models. 3D Systems says it is the only company tooffer a solution that combines its own software and printers to create 3Dprinted patient-specific anatomic models for diagnostic purposes medicalspecialties including: cardiovascular, craniofacial, gastrointestinal,genitourinary, neurological, and musculoskeletal applications. D2P relies onunique automatic segmentation tools driven by deep learning that allow medicalpractitioners to quickly create accurate, digital 3D anatomic models frommedical imaging data. With the additional FDA clearance, D2P addresses thegrowing demand by point of care (POC) institutions for in-house manufacturingusing a 3D segmentation solution that can produce 3D printed models.

D2P now also includes the latest advancements in deeplearning image processing technology and virtual reality visualization,allowing hospitals and device manufacturers to significantly reduce the timeassociated with the creation of 3D models.

The software also includes a volumetric VR (virtual reality)solution, enabling instant views of patient scans in a 3D environment –facilitating surgical planning and conversations between medical staff andtheir patients.

“We are used to going into surgery with uncertainties and anarsenal of contingency plans,” said Dr. Solomon Dadia, deputy director of theorthopedic-oncology department and director of the 3D surgical center atSouraski Medical Center in Tel-Aviv. “With 3D printed models and enhanced 3Dvisualization tools such as VR, we are able to gain a better understanding ofthe surgery and pathology we are going to treat. This allows us to come up witha more precise surgery plan designed to deliver a better surgical outcome.”

In accordance with the FDA announcement on new guidelinesfor 3D printed patient-specific anatomic models in 2017, diagnostic qualitymodels must be an output of a Class II regulated medical device software. 3DSystems is the only company to offer both a software solution and compatibleprinters of its own that meet this regulatory requirement. Anatomic models canbe produced using a variety of 3D Systems printing technologies – ColorJetPrinting, MultiJet Printing, Stereolithography, and Selective Laser Sintering –including materials that are sterilizable and biocompatible.