Mar 26, 2018 | By Benedict

3D printing software company Materialise has become the first company to receive FDA clearance for 3D printed anatomical model software intended for diagnostic use. 16 of the top 20 hospitals in the U.S. use Materialise’s Mimics software.

The U.S. Food & Drug Administration’s regulation on 3D printing in the healthcare industry is still a work in progress, though it is coming along steadily. Last year, for example, after taking the advice of numerous experts and businesses, the FDA published its guidance on the 3D printing of medical products.

This attempted to cover everything from plastic models to titanium implants (with a view to incorporating things like bioprinted organs in the future), and is the clearest picture yet of how medical device companies should go about making their products in order to gain FDA clearance and have their products used in hospitals across America.

Some medical 3D printing products, however, are tricky to regulate and classify. Software, for example, is not easy to talk about with the same terminology as physical objects, yet in August last year the FDA decided to classify medical 3D printing software as a “class II medical device,” which therefore requires regulatory clearance.

So who was up to the challenge of meeting the FDA’s strict criteria on medical 3D printing software? Well, lots of companies, we hope, but one company has beaten all others to the punch.

Materialise, the Belgian 3D printing software company known for its wide range of additive manufacturing solutions, has just become the first company to receive FDA clearance for diagnostic 3D printed medical models software, meaning hospitals across the U.S. can freely use Materialise software like Mimics to 3D print anatomical models on approved 3D printers.

One of the company’s most important software solutions for medical 3D printing, Materialise Mimics inPrint, is now certified with 510k clearance. This 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.

“Materialise has nearly three decades of experience in developing certified medical solutions that create a better and healthier world,” commented Wilfried Vancraen, Materialise CEO. “The FDA clearance for our Mimics inPrint software will support the adoption of 3D planning and printing in U.S. hospitals and the creation of point-of-care 3D printing facilities.”

Excitingly, many hospitals are already taking steps to implement the healthcare 3D printing solutions provided by Materialise. Of the top 20 U.S. hospitals (according to a US News and World Report), 16 already use Materialise Mimics in their 3D printing strategy.

Ultimately, anatomical models such as those 3D printed using Materialise software can be used to better point-of-care options in hospitals. Such 3D printed anatomical models can help surgeons to make better decisions and to plan procedures, and can be used to train medical staff and communicate diagnoses and planned procedures with patients and their families.

Materialise might be first company to step up to the FDA’s new requirements, but it certainly won’t be last.



Posted in 3D Software



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