3D printing firm receives 510(k) clearance for software for anatomic models

3D Systems has received 510(k) clearance for its D2P (DICOM-to-PRINT) software allowing clinicians to 3D print diagnostic patient-specific anatomic models.

The company offers a solution that combines its own software and printers to create 3D printed patient-specific anatomic models for diagnostic purposes in 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.

The software includes advancements in deep learning image processing technology and virtual reality visualisation allowing hospitals and device manufacturers to reduce the time associated with the creation of 3D models.

It also provides a volumetric VR solution enabling instant views of patient scans in a 3D environment. 

Dr. Solomon Dadia, deputy director of the orthopaedic-oncology department and director of the 3D surgical centre at Souraski Medical Centre in Tel-Aviv, said: “We are used to going into surgery with uncertainties and an arsenal of contingency plans. With 3D printed models and enhanced 3D visualisation 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. 

Ran Bronstein, vice president, chief research and operation officer, 3D Systems, said: “The capabilities offered in D2P give the healthcare professional an unprecedented toolset for deeper medical understanding across most medical specialties. Our proprietary advanced visualisation technology is changing how medical imaging data is used in a variety of formats such as virtual reality and 3D printed physical models.”