DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

3D Printing Homepage

GE and VA partner to build 3D printing network Holds promise for reducing surgery imaging preparation time

Apple obtains patent for new 3D printing method Produce objects faster with fewer materials

VA researchers working on 3D-printed artificial lung Would serve as a 'bridge' until reaching a permanent transplant

Purdue research groups enhancing medical imaging with optical innovations Developing optical ultrasound and 3D printed, optical phantoms

Could AI and 3D printing be the future of OB/GYN ultrasound? Few specialities are equally poised to embrace these cutting edge tools

New approach promises rapid 3D model production More realistic detailed physical models retain anatomical accuracy

MIT research yields more efficient anatomical 3D printing How 'dithered bitmaps' may increase accessibility of 3D printing in imaging

NHS surgeons use 3D printing to perform lifesaving kidney transplant Stratasys technology used to plan operation on two-year-old boy

How 3D printing could reduce complications after TAVR Using the pre-procedure CT data to create a model that can be implanted with a valve

Opportunities and challenges with 3D printing in cardiology A world of potential but costs remain a barrier

Materialise promotes new FDA certification process for 3D printing

by Lisa Chamoff , Contributing Reporter
As 3D printing in healthcare has expanded, the FDA has issued new guidance on the printers, materials and software that can be used to create 3D-printed models of the anatomy for diagnostic and surgical planning uses.

In March, 3D printing software company Materialise became the first company to receive a new FDA clearance for diagnostic use of its 3D printing anatomical model software.

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED



Materialise then launched an FDA-approved certification program, which allows printer manufacturers to have their products tested and validated for use with Materialise’s Mimics inPrint software, which converts medical images into the file format needed for 3D printing.

The certification process involves “what Materialise has developed based on expertise in the market," Todd Pietila, global business development manager for hospital 3D printing at Materialise, told HCB News during an interview at the show. “It’s reproducibility testing and geometric accuracy testing, ensuring that the file coming into the printer will be accurately manufactured.”

At the 2018 RSNA annual meeting at RSNA, Materialise announced that Stratasys and Ultimaker were the latest 3D printing hardware and materials manufacturers to have had their products certified.

Stratasys’s J750/J735, Object30 Prime and Connex 2 500 printers and Ultimaker’s 5S printer, as well as certain materials, are on the Materialise list of printers and materials that are suitable for orthopedic, cranio-maxillofacial and cardiovascular anatomical models, along with the Formlabs Form 2 printer.

While the FDA doesn’t have oversight when it comes to the practice of medicine, if a hospital is marketing its 3D printing services then they have to use FDA-cleared products.

“Other than just the peace of mind of using a cleared solution, it gives a higher level of trust and makes the decision-making much simpler when hospitals are starting 3D printing,” Pietila said. “They don’t have to go out and talk to three or four different vendors, buy separate components, try to piece them together, make sure they all work together. It’s a pre-vetted system of software, hardware and materials. And it just the reduces the overhead and burden for them.”

Michael Gaisford, director of healthcare solutions at Stratasys, said the new verification process is an important step forward for 3D printing in healthcare, which can help facilities perform faster, less invasive procedures, resulting in lower costs and better patient care.

“You want to be ahead of the curve when it comes to the FDA,” Gaisford told HCB News. “The hospitals want to see this as well because they’re making some pretty critical decisions when it comes to patient care. … Those who are involved in the space are already asking for it.”

3D Printing Homepage


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED