Ricoh USA, Inc.
Ricoh USA, Inc. has announced RICOH 3D for Healthcare, a HIPAA-compliant, ISO 13485 certified 3D medical manufacturing centre for the development, design, and production of 3D printed anatomic models, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The clearance is for new areas of patient-specific anatomic modelling for diagnostic use, including cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications.
Ricoh previously received FDA 510(k) clearance for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modelling in June 2022. The expanded clearance empowers Ricoh to support more surgical specialties and patient diagnoses to print diagnostic quality 3D anatomic models of bony and soft tissue using Stratasys 3D printing technology and materials according to Ricoh.
“Receiving the expanded 510(k) clearance for anatomic modelling of soft tissue is an exciting milestone for Ricoh as we continue to lead the way in offering democratised access to patient-specific 3D printed models in healthcare,” said Gary Turner, Managing Director, Additive Manufacturing, North America, Ricoh USA, Inc.
The workflow at Ricoh integrates with Merge Universal Viewer (formerly IBM iConnect Access), an enterprise imaging solution from Merative (formerly IBM Watson Health) that is used in hospitals around the United States, which Ricoh says will make it easy to fit into a provider’s existing workflow.
The integration capabilities will allow providers to request 3D printed anatomic models using Ricoh’s centralised print-and-ship solution for same-week delivery, or produce the models at a Ricoh-managed, point-of-care production facility onsite at the healthcare facility for next day delivery according to the company.
“Ricoh’s ability to 3D print various materials – now expanded to additional areas of anatomy under the new 510(k) – will assist our care team in better understanding what surgeons and interventionalists can expect to see in the operating room before they ever step foot inside,” said Dr. Vishal Gupta, Co-Chair, Ascension Borgess Heart Institute. “Patient-specific models for diagnostic purposes are crucial in pre-surgical planning and can also support clinicians in better educating patients about what procedures will entail – something we recently did for a case.”
