FDA clears 3D print application for head/face and ortho structures
A new system for developing and printing 3D models of tissue and bone from clinical CT images has been regulatorily OK’d for sale in the U.S.
Ricoh USA announced the approval of its 3D for Healthcare craniomaxillofacial and orthopedic application June 15.
The company says the product leverages 3D-printing technology from Stratasys Ltd. and enterprise imaging software from IBM Watson Health to create patient-specific models within providers’ existing workflows.
The offering lets the provider choose between stationing Ricoh staff onsite or sending image data out to Ricoh for completing the print and shipping the finished model back to the provider.
In either case, Ricoh “provides recommended [CT] scanning protocols to optimize the image data acquisition for use in 3D printing,” a company product specialist tells RB.
Ricoh plans to solicit 510(k) clearance for additional treatment regions in the future, according to the June 15 announcement.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.