Technology | Medical 3-D Printing | March 23, 2018

Materialise First Company to Receive FDA Clearance for Diagnostic 3-D-Printed Anatomical Models

FDA clearance supports the continued growth of point-of-care 3-D printing facilities

Materialise First Company to Receive FDA Clearance for Diagnostic 3-D-Printed Anatomical Models

March 23, 2018 — Materialise NV became the first company in the world to receive U.S. Food and Drug Administration (FDA) clearance for software intended for 3-D printing anatomical models for diagnostic use. The company said leading hospitals are adopting integrated 3-D printing services as part of their medical practices as they recognize the added value it brings to personalized patient care.

In August 2017, the FDA announced that software intended to create output files used for printing 3-D patient-specific anatomical models used for diagnostic purposes is a Class II medical device and requires regulatory clearance. Materialise is the first company to provide software that conforms to these regulations and that can be used in U.S. hospitals in combination with a compatible 3-D printer. Materialise Mimics inPrint software is used for pre-operative planning and the fabrication of physical models for diagnostic purposes, including patient management, treatment and surgeon-to-surgeon communication.

Frank J. Rybicki, M.D., Ph.D., chief of medical imaging at Ottawa Hospital, Ontario, Canada, said: “510k clearance is an essential component to ensure quality and safety in the practice of anatomical modeling in hospitals. This milestone for Materialise serves as a benchmark for the clinical implementation of 3-D printing for physicians creating 3D models at the point-of-care.”

The FDA clearance supports the creation of point-of-care 3-D printing facilities in hospitals. Anatomical models help surgeons to make better-informed decisions and to accurately plan their surgeries. They are also used to enhance education and communication between multidisciplinary teams and with the patient. Materialise said an increasing number of hospitals across the U.S. have integrated the practice of 3-D printing in their medical care and are creating point-of-care 3-D printing facilities. Out of the top 20 U.S. hospitals (as ranked by the U.S. News and World Report), 16 have reportedly implemented a medical 3-D printing strategy using Materialise Mimics technology.

For more information: www.materialise.com

 

Related Content

SmartCurve technology, a revolutionary breast imaging technology designed specifically for the curvature of the female breast to provide every woman with a more comfortable and accurate mammogram.
News | Mammography | September 14, 2018
Solis Mammography declared September Breast Wellness Month a
At RSNA 2018, radiology professionals will discover intelligent radiography powered by MUSICA, at Agfa's booth.

At RSNA 2018, radiology professionals will discover intelligent radiography powered by MUSICA, at Agfa's booth.

News | Digital Radiography (DR) | September 13, 2018
At RSNA 2018, radiology professionals will discover intelligent
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
Veye Chest version 2
News | Lung Cancer | September 11, 2018
Aidence, an Amsterdam-based medical AI company, announced that Veye Chest version 2, a class IIa medical device, has
Sponsored Content | Whitepapers | Radiation Dose Management | September 10, 2018
It’s crucial for medical professionals to understand the radiation risk/ benefit balance of diagnostic imaging system
RSNA Announces Pneumonia Detection Machine Learning Challenge
News | Artificial Intelligence | August 27, 2018
The Radiological Society of North America (RSNA) has launched its second annual machine learning challenge. The RSNA...
Videos | Artificial Intelligence | August 23, 2018
Radiological Society of North America (RSNA) President...
Philips Launches Epiq CVx and CVxi Cardiovascular Ultrasound Systems
Technology | Cardiovascular Ultrasound | August 22, 2018
Philips recently announced the introduction of the Epiq CVx cardiovascular ultrasound system. Built on the Epiq...