RICOH 3D for Healthcare Receives Expanded FDA 510(k) Clearance for 3D Anatomic Modeling of Soft Tissue
Ricoh USA announced RICOH 3D for Healthcare – a HIPAA-compliant, ISO 13485 certified 3D medical manufacturing center 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) for new areas of patient-specific anatomic modeling 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 modeling 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.
“Receiving the expanded 510(k) clearance for anatomic modeling of soft tissue is an exciting milestone for Ricoh as we continue to lead the way in offering democratized access to patient-specific 3D-printed models in healthcare,” said Gary Turner, managing director, Additive Manufacturing, North America, Ricoh USA, Inc. “As a manufacturer of precision additive medical devices, Ricoh offers one of the broadest scopes of FDA-cleared 3D models for anatomic regions and a wide range of print materials available for diagnostic use – which combine to improve outcomes, enhance the patient experience and increase opportunities for physician education and training.”
The end-to-end workflow solution integrates with Merge Universal Viewer (formerly IBM iConnect Access), an enterprise imaging solution from Merative (formerly IBM Watson Health) that is used in many hospitals across the U.S., making it easy to fit into a provider’s existing workflow. The integration capabilities allow providers to request 3D-printed anatomic models using Ricoh’s centralized 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.
“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.”
Ricoh 3D for Healthcare produces patient-specific anatomic models via additive manufacturing, using segmented 3D print files created from medical images in FDA-cleared applications. These models are used for diagnostic purposes in various medical fields, including craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications. With the ability to manage 3D print operations at the point of care, Ricoh 3D for Healthcare provides a streamlined and efficient solution for producing these models.