Ricoh’s Healthcare Solution OKs FDA 510(k) Clearance
Company takes next major step in providing widespread access to patient-specific 3D models helping healthcare providers deliver precision medicine.
June 15, 2022
RICOH 3D for Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling.
RICOH 3D for Healthcare is an integrated HIPAA-enabled end-to-end workflow solution for the development, design and production of 3D-printed anatomic models, produced using Stratasys 3D printing technology, that enable healthcare providers to develop patient-specific representations of tissue and bone.
The replicas help clinicians see inside anatomy for greater visibility into patient needs. RICOH 3D for Healthcare integrates with IBM iConnect Access, an enterprise imaging solution from IBM Watson Health that is used in many hospitals across the U.S., making it easy to integrate into an existing workflow.
According to the Radiological Society of North America (RSNA) 3D Printing Special Interest Group, the use of 3D printing technologies to aid clinical care in the CMF area has been in demand from the advent of 3D printing in the late 1980s. Surgeons, engineers and researchers were designing more manual ways of converting medical imaging datasets into 3D models even before the commercialization of 3D printing technologies.
Patient-specific anatomical models are the baseline in the CMF arena, according to the report, and there is a growing body of work that supports the benefits of 3D-printed models. These include increased comprehension of anatomy and pre-surgical planning for complex surgical cases, as well as a reduction in operation times and improved patient outcomes.
Ricoh plans to solicit 510(k) clearance for additional treatment regions in the future.
For more information about RICOH 3D for Healthcare, view the brochure on the RICOH 3D for Healthcare webpage.
Sources: Press materials received from the company and additional information gleaned from the company’s website.