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

Nihon Kohden Launches Augmented Reality Electrophysiology Training App at HIMSS18
Technology | Advanced Visualization | March 06, 2018
Nihon Kohden announced the launch of the Nihon Kohden Dimensions Augmented Reality (AR) App to complement the Clinical...
NIH Issues $2.2 Million Grant for Augmented Reality Cardiac Hologram Research
News | Advanced Visualization | February 15, 2018
February 15, 2018 — The National Institutes of Health (NIH) awarded a $2.2 million research grant to healthcare techn
EchoPixel Showcases Next-Generation Surgical Planning With True 3-D Interactive Mixed Reality Software
News | Advanced Visualization | January 08, 2018
EchoPixel showcased the latest version of True 3D, its interactive, mixed reality software solution at the 103rd Annual...
Videos | Advanced Visualization | December 07, 2017
Dianna Bardo M.D., director of body MR and co-director of the 3-D Innovation Lab at Phoenix Children's Hospital, disc
Vital Unveils Newest Vitrea Advanced Visualization Release at RSNA 2017
Technology | Advanced Visualization | December 04, 2017
December 4, 2017 — Vital Images unveiled the newest version of Vitrea...
Arterys Completes Series B to Accelerate Product Commercialization
News | Advanced Visualization | November 15, 2017
Arterys Inc. announced the close of its $30M Series B financing round. The investment was led by Temasek, with...
TeraRecon Introduces 175-Plus New Features in iNtuition 4.4.13
Technology | Advanced Visualization | November 06, 2017
November 6, 2017 — TeraRecton announced the launch of version 4.4.13 of its iNtuition...
TeraRecon Enhances Speed, Clinical Capabilities With Latest iNtuition Release
Technology | Advanced Visualization | October 25, 2017
October 25, 2017 — TeraRecon announced the release of version 4.4.13 of their iNtuition software, bringing over 175 n
Analytics 4 Life Raises $25 Million for AI-Backed Cardiac Imaging Technology
News | Advanced Visualization | October 20, 2017
October 20, 2017 — Digital health company Analytics 4 Life announced it has completed a $25 million Series B financin
Echopixel, True 3D Viewer, interactive virtual reality, pediatric surgery, increased clinical adoption
News | Advanced Visualization | March 21, 2017
March 21, 2017 — EchoPixel recently announced progress in the clinical adoption of its True 3D...
Overlay Init