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

Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite
Technology | Advanced Visualization | June 13, 2019
Three-dimensional (3-D) printing software and solutions company Materialise has received U.S. Food and Drug...
Medivis SurgicalAR Gets FDA Clearance
Technology | Virtual and Augmented Reality | June 10, 2019
Medivis announced that its augmented reality (AR) technology platform for surgical applications, SurgicalAR, has...
Ann Arbor Startup Launches Augmented Reality MRI Simulator
Technology | Virtual and Augmented Reality | June 04, 2019
SpellBound, an Ann Arbor startup specializing in augmented reality (AR) tools for children in hospitals, has officially...
Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carrie Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carri Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Feature | Henry Ford Hospital | May 21, 2019 | Dave Fornell, Editor
Henry Ford Hospital thought leaders regularly speak at the radiation oncology and radiology conferences about new res
Videos | Digital Radiography (DR) | May 20, 2019
This is a quick walk-around video showing the ...
Videos | Advanced Visualization | May 16, 2019
This is an example of how virtual reality is being used in neuro-radiology to better evaluate patients using advanced
he DigitalDiagnost C90 is Philips newest premium digital radiography (DR) system, introduced here at the Radiological Society of North America (RSNA) 2018 meeting. It is the industry’s first radiography unit with a live camera image directly displayed at the tube head to provide a clear view of the anatomical area being scanned during the patient positioning process.
360 Photos | 360 View Photos | May 08, 2019
The DigitalDiagnost C90 is Philips newest premium ...
Bioprinting research from the lab of Rice University bioengineer Jordan Miller featured a proof-of-principle — a scale-model of a lung-mimicking air sac with airways and blood vessels that never touch yet still provide oxygen to red blood cells.

Bioprinting research from the lab of Rice University bioengineer Jordan Miller featured a proof-of-principle — a scale-model of a lung-mimicking air sac with airways and blood vessels that never touch yet still provide oxygen to red blood cells. Image courtesy of Jordan Miller/Rice University.

News | Medical 3-D Printing | May 03, 2019
Bioengineers have cleared a major hurdle on the path to 3-D printing replacement organs with a breakthrough technique...
A 3-D printed tungsten X-ray system collimator. 3D printed, additive manufacturing for medical imaging.

A 3-D printed tungsten X-ray system collimator. The tungsten alloy powder is printed into the form desired and is laser fused so it can be machined and finished. Previously, making collimators from Tungsten was labor intensive because it required working with sheets of the metal to create the collimator matrix. 

Feature | Medical 3-D Printing | April 29, 2019 | By Steve Jeffery
In ...