3D Systems Receives FDA Clearance for D2P Software - MTM

3D Systems Receives FDA Clearance for D2P Software

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

D2P now also includes the latest advancements in deep learning image processing technology and virtual reality visualization, allowing hospitals and device manufacturers to significantly reduce the time associated 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 and their patients.

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

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