fda regulations
Simpleware ScanIP Medical Software Receives 510(k) Clearance for 3D Printed Diagnostics
Synopsys, with its worldwide headquarters located in California and a score of other locations all across the globe, is focused on smart technology, and with more than 30 years in…
LimaCorporate and HSS Open First Hospital-Based Facility for 3D Printed Implants
In 2019, global orthopedics manufacturing company LimaCorporate S.p.A. and the Hospital for Special Surgery (HSS), the top-ranked orthopedic hospital in the United States, announced that they were partnering to establish the…
3D Systems and Veterans Health Administration Partner for 3D Printing at Point-of-Care for Veterans
It’s no secret that 3D printing has done a lot to help during the ongoing COVID-19 pandemic, even while it’s causing havoc in our own industry, as well. 3D Systems…
Virtual AM Medical Event: From Innovations to the Future of Additive Manufacturing in the Medical Industry
The American Society of Mechanical Engineers (ASME) hosted a first-of-its-kind event with experts discussing the instrumental role and impact of additive manufacturing (AM) on patient care. Originally set to take…
AMS 2020: Panels on 3D Printing in Implants and Orthopedics, Regulation in Additive Medical Devices
There was much to enjoy and learn at the recent Additive Manufacturing Strategies event, held in Boston and co-hosted by 3DPrint.com and SmarTech Analysis, especially with the addition of a…
Meeting New FDA Quality Management Requirements for Additive Manufacturing Software
In 2019, the FDA, in collaboration with its peer regulatory organizations in the industrialized world through the IMDRF program, adopted a new definition of “Software as a Medical Device” (SaMD)…
Additive Orthopaedics Receives 510(k) Clearance for Patient Specific 3D Printed Bone Segments
It seems like just about every day, we’re learning of new 3D printing innovations in the medical field, from prosthetics and pharmaceuticals to anatomical models, surgical guides, and implants. But…
Insights from the FDA on the Future of 3D Printing in Medical Markets
As additive manufacturing has made its way into the healthcare arena, the technology has opened up new possibilities in the creation of patient-specific medical products such as anatomical models and…
3D Printing, Medical Models, Intellectual Property, and the FDA: Expert Gathering at Additive Manufacturing Strategies Summit
While adding more events to an already packed calendar year in technology can seem to be a tricky proposition, it takes differentiation and careful curation for any new happening to…
FDA Guidance for 3D Printing of Medical Devices and Eligible R&D Tax Credits
The exponential growth of 3D printing technology and its application across various industries has been tremendous. In the medical field specifically, 3D printing has contributed to both clinical and innovative…
17 Top 3D Printing Themes of 2017
2017 has been, by any measure, an eventful year, and as always the end of December brings us to a retrospective season as we look back on all that has…
FDA Commissioner Releases Statement and New Guidance on 3D Printed Medical Devices
You can’t get anywhere with 3D printed medical products and devices in the US market without the extremely important approval of the Food and Drug Administration (FDA), an agency within the…
Stryker and Omegasonics Receive Important Industry Certifications for 3D Printed Spinal Implant and Ultrasonic Cleaning Unit
In the winter of 2016, medical device manufacturing company Stryker decided to commit to 3D printing and announced the launch of a 3D printed spinal implant, as well as a planned…
Read Before You Vape: 3D Printed Screening Device Shows That E-Cigarettes Are Just as Bad as Tobacco Cigarettes
In season three of Friends, my favorite sitcom in the world, Rachel Green tries to help her friend Chandler Bing quit smoking, first by physically removing cigarettes from his mouth,…
Organovo’s 3D Printed Liver Tissue Shows Extended Survival and Function in Animal Test Subjects
Organovo is a well-known company to anyone involved in 3D printing, tissue engineering or both. While many are familiar with the company’s 3D printed liver and kidney tissues, however, it’s…
3D Printers Used to Manufacture Medical Parts Should Be Regulated
As a company that has been inventing and manufacturing 3D printers and materials for 15 years, our company has had a front-row seat to amazing changes in the way things…
FDA Approved: OssDsign AB Will Now Offer 3D Printed Cranial Implant Technology in US
While the impacts of 3D printing are being seen around the world and in nearly every major industry, it’s hard to imagine what could be more important than the progress…
FDA Video Introduces the Three Rs of Medical 3D Printing
It’s always exciting when 3D printing can play a role in making someone’s life better, and one of the very visible ways it does this is through the medical field,…
3D Printing: The Stories We Missed This Week — August 13, 2016
Another week, another set of 3D printing stories from around the world that we’ve yet to have the chance to cover. For starters, Wanhao USA has continued their North American…
The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing
When a magical new technology comes along, capable of stunning us at nearly every turn, it’s especially thrilling to be one of the rare few to be involved from the…
Materialise: Innovative X-Ray Knee Guide System Rejected By FDA
When following new innovations in the medical and healthcare industries, it often may not be apparent immediately, but if you dig deeply enough you will find involvement from Materialise in…
FDA to Hold Public Workshop in October to Discuss 3D Printing Regulations
The Food and Drug Administration has a responsibility of protecting the public’s health, by assuring the safety of drugs, medical devices, and food supplies. Often times people forget that their…
