FDA clears 3D Systems’ D2P software for anatomical models

3D Systems has received additional 510(k) clearance for its D2P (DICOM-to-PRINT) software for the medical industry. The software, which enables clinicians to easily 3D print patient-specific anatomical models, works in tandem with 3D Systems’ 3D printers to create models for a range of medical areas, including cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological and musculoskeletal applications.

The additional clearance from the FDA will allow the D2P software to meet the growing demand by point-of-care institutions for the in-house production of patient-specific 3D printed models in order to prepare for complex surgical procedures and conduct more accurate diagnostics.

“We are used to going into surgery with uncertainties and an arsenal of contingency plans,” explained 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 2017, the FDA announced a series of guidelines for 3D printed patient-specific anatomical models, which stipulated that models for diagnostic use must be an output of a Class II regulated medical device software. Today, 3D Systems says it is the only company that offers both an approved software solution and compatible 3D printers (including ColorJet Printing, MultiJet Printing, SLA and SLS) that meet this requirement. The company also offers a range of biocompatible and sterile printing materials.

3D Systems’ D2P software now includes deep learning image processing capabilities as well as virtual reality visualization, which enables medical professionals to reduce turnaround times for 3D printed anatomical models. The software also include a volumetric VR solution that lets users see instant 3D views of a patient’s scan, which can speed up surgical planning and enhance communication between doctors and patients.

“The capabilities offered in D2P give the healthcare professional an unprecedented toolset for deeper medical understanding across most medical specialities,” commented Ran Bronstein, Vice President, Chief Research and Operation Officer at 3D Systems. “Our proprietary advanced visualization technology is changing how medical imaging data is used in a variety of formats such as virtual reality and 3D printed physical models.”