fda regulations

Insights from the FDA on the Future of 3D Printing in Medical Markets

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 surgical guides. Due to the delicate nature of these devices and the critical care applications in which they may find use, the US Food and […]

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 surgical guides. Due to the delicate nature of these devices and the...
3D Printing, Medical Models, Intellectual Property, and the FDA: Expert Gathering at Additive Manufacturing Strategies Summit

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 truly stand out — and this is why we worked with the diligent team at SmarTech Markets Publishing to put on this week’s Additive Manufacturing […]

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 truly stand out — and this is why we worked with the diligent team at SmarTech...
FDA Guidance for 3D Printing of Medical Devices and Eligible R&D Tax Credits

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 advancements. Additive manufacturing technologies have been applied to medical equipment, prosthetics, dental products, bioprinting, and pharmaceuticals. However, before these technological advancements can be utilized for […]

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 advancements. Additive manufacturing technologies have...
17 Top 3D Printing Themes of 2017

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 happened. For us, that means a look back on some of the major happenings in the 3D printing industry, as each year we look into […]

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 happened. For us, that means a look back on some of the major happenings in the 3D printing industry, as each year we...
FDA Commissioner Releases Statement and New Guidance on 3D Printed Medical Devices

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 country’s Department of Health and Human Services. It takes a lot of hard work for a new medical innovation to receive FDA clearance, and not […]

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 country’s Department of Health and Human Services. It takes a lot...
Stryker and Omegasonics Receive Important Industry Certifications for 3D Printed Spinal Implant and Ultrasonic Cleaning Unit

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 3D printing manufacturing facility. Soon after, the company’s Spine division debuted its 3D printed Tritanium posterior lumbar (PL) cage spinal implant, and completed a successful […]

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 3D printing manufacturing facility. Soon after, the company’s Spine division...
Read Before You Vape: 3D Printed Screening Device Shows That E-Cigarettes Are Just as Bad as Tobacco Cigarettes

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, and then by giving him a hypnosis tape. Chandler, perpetually sarcastic, balances the tape on his arm like it’s a nicotine patch and watches in […]

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, and then by giving him a hypnosis tape. Chandler, perpetually sarcastic, balances the...
Organovo's 3D Printed Liver Tissue Shows Extended Survival and Function in Animal Test Subjects

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 still hard to keep up with the momentum of Organovo and their technology. The bioprinting company has released several sets of promising data from studies […]

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 still hard to keep up with the momentum of Organovo and their...
3D Printers Used to Manufacture Medical Parts Should Be Regulated

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 are made. We are also confident that much more progress is on the horizon, especially when it comes to medical applications. While the benefits to […]

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 are made. We are also confident that much more progress is on the horizon, especially when it comes...
FDA Approved: OssDsign AB Will Now Offer 3D Printed Cranial Implant Technology in US

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 we are seeing in the medical field today. With the opportunities to customize medical devices, implants, and much more, medical professionals are able to offer […]

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 we are seeing in the medical field today. With the opportunities to customize medical...
FDA Video Introduces the Three Rs of Medical 3D Printing

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, like with this 3D printed ankle fusion system, or this 3D printed titanium digital fusion implant. But you can’t get anywhere with some of these […]

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, like with this 3D printed ankle fusion system, or this 3D printed titanium digital fusion...
3D Printing: The Stories We Missed This Week — August 13, 2016

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 expansion with the opening of their new service center in San Diego, California. The dental digital tech company Argen Corporation has enlisted Concept Laser’s Mlab […]

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 expansion with the opening of their new service center in San Diego, California. The dental...
The FDA Releases Draft Guidance for Industry & Food & Drug Administration Staff Regarding 3D Printing

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 beginning. Users are operating on a new frontier—and a lawless one for the most part, to begin with. Eventually though, concerns arise, and so do […]

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 beginning. Users are operating on a new frontier—and a lawless one for the most part, to begin with....
Materialise: Innovative X-Ray Knee Guide System Rejected By FDA

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 the majority of 3D printed devices, models, and implants being made for the healthcare system. The Belgium-based company is also often first on the list […]

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 the majority of 3D printed devices, models, and implants being made for the...
FDA to Hold Public Workshop in October to Discuss 3D Printing Regulations

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 other responsibility is to stimulate innovation in order to advance the health of our citizens. These two initiatives often get in the way of each […]

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 other responsibility is to stimulate innovation in order to advance...
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