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RICOH 3D for Healthcare Receives Expanded FDA 510(k) Clearance for 3D Anatomic Modeling of Soft Tissue

Thursday, May 04, 2023

Ricoh USA, Inc. has announced the 510(k) clearance from the FDA for RICOH 3D for Healthcare, a HIPAA-compliant and ISO 13485 certified 3D medical manufacturing center. This clearance allows for the development, design, and production of 3D-printed anatomic models for diagnostic use in various medical specialties, including cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications.

Building upon its previous FDA clearance for craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling, Ricoh can now support a broader range of surgical specialties and patient diagnoses. By utilizing Stratasys 3D printing technology and materials, Ricoh is able to deliver high-quality 3D anatomic models of both bony and soft tissue structures.

This expanded clearance signifies Ricoh's commitment to democratizing access to patient-specific 3D-printed models in healthcare. By offering a comprehensive range of FDA-cleared 3D models and diagnostic materials, Ricoh aims to improve patient outcomes, enhance the patient experience, and provide valuable opportunities for physician education and training.

The workflow solution seamlessly integrates with Merge Universal Viewer, an enterprise imaging solution from Merative (formerly IBM Watson Health), widely used in hospitals across the U.S. This integration enables healthcare providers to request 3D-printed anatomic models through Ricoh's centralized print-and-ship solution for fast delivery or produce the models onsite at a Ricoh-managed point-of-care production facility for next-day delivery.

Dr. Vishal Gupta, Co-Chair of Ascension Borgess Heart Institute, highlights the importance of patient-specific models for pre-surgical planning and patient education. Ricoh's expanded ability to 3D print various materials provides valuable insights for surgeons and interventionalists, allowing them to better prepare for procedures and improve patient outcomes.

Ricoh 3D for Healthcare leverages additive manufacturing and FDA-cleared applications to produce patient-specific anatomic models from medical images. With a focus on craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications, Ricoh's streamlined solution ensures efficient production of these diagnostic models at the point of care.

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