Ultimaker Gains Certification as Part of Materialise's 510(k) Cleared Mimics inPrint Software

Certified Partnership with Materialise Brings Safe, Accessible, Reliable 3D Printing to Point-of-Care Diagnostics

Ultimaker, the global leader in desktop 3D printing, today announced that the Ultimaker S5 has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models for clinical use when used in combination with Mimics inPrint software. The company partnered with Materialise to identify compatibility of the Ultimaker S5 with Materialise Mimics inPrint software to meet FDA regulatory guidelines for point-of-care 3D printing in hospitals.


In 2017, the FDA announced that software intended to create output files for 3D printing patient-specific anatomical models, which are used for diagnostic purposes, is considered a class II medical device and requires regulatory clearance. Materialise was the first company to provide a software that conforms to these regulations and can be used in U.S. hospitals in combination with a compatible 3D printer. After rigorous performance testing and analysis, Materialise and Ultimaker identified that the Ultimaker S5 printer, used in conjunction with PLA and PVA materials, can be safely used with the Materialise Mimics inPrint software for 3D printing models that are used for diagnostic purposes.

"More and more frequently, doctors look to 3D printing for pre-operative planning and the fabrication of physical models for patient management, treatment and surgeon-to-surgeon communications. As diagnostic usage of 3D printers continues to revolutionize patient care, safety and quality remain a top concern for hospitals," said John Kawola, president of Ultimaker North America. "The Materialise certification of the 3D printing workflow when used with Mimics inPrint reduces the safety- and quality-control burden on doctors and hospitals with it's clearance by the FDA."

The medical 3D printing solution leverages software from Materialise, a Leuven, Belgium-based leader in 3D printing software and solutions. When used with Materialise certified materials and specific printers from companies like Ultimaker, Mimics inPrint is the only 3D printing software cleared by the FDA to create anatomical models for patient care. "Starting with a validated system of hardware, software and materials for medical 3D printing helps reduce the burden on hospitals' quality control programs when introducing the technology," said Bryan Crutchfield, vice president and general manager of Materialise North America. "This solution we've developed with Ultimaker will improve access to 3D printed anatomical models to aid in surgical planning and multidisciplinary team communication."

For more information about how point-of-care 3D printing can be used in hospitals, please visit https://www.materialise.com/medical and this blog post or visit Ultimaker and Materialise at the upcoming RSNA 2018 Annual Meeting on November 25-30 in Chicago.

About Ultimaker
Ultimaker has been in operation since 2011, and over the years has grown to become a market leader; creating powerful, professional, and accessible desktop 3D printers with offices in the Netherlands, New York, Boston, and Singapore, plus production facilities in Europe and the US. Ultimaker's team of over 350 employees continually strives to offer the highest-quality 3D printers, software, and materials on the market to accelerate the world's transition to local digital manufacturing. ultimaker.com

About Materialise
Materialise incorporates 27 years of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise's open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world. For additional information, please visit: www.materialise.com.

About Materialise Medical
Materialise Medical, which has pioneered many of the leading medical applications of 3D Printing, enables researchers, engineers and clinicians to revolutionize innovative patient-specific care. Materialise Medical's open and flexible platform of software and services, Materialise Mimics, forms the foundation of certified Medical 3D Printing, in clinical as well as research environments, offering virtual planning software tools, 3D-printed anatomical models, and patient-specific surgical guides and implants. For additional information, please visit: materialise.com/medical.

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