3d printing fda regulations

Stryker’s Latest 3D Printed Spinal Implant Receives FDA Clearance

Stryker’s Latest 3D Printed Spinal Implant Receives FDA Clearance

3D printing has played a big role in helping those with spinal conditions, and one of the most prominent companies in the 3D printed spinal implant sector has been Stryker. The medical device company debuted its 3D printed Tritanium Posterior Lumbar Interbody Cage in 2016, featuring Stryker’s proprietary Tritanium Technology, and now the company has […]

3D printing has played a big role in helping those with spinal conditions, and one of the most prominent companies in the 3D printed spinal implant sector has been Stryker. The medical device company debuted its 3D printed Tritanium Posterior Lumbar Interbody Cage in...
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...
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...
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...
FDA (510)k Clearance Awarded to 3D Printed Medical Implants from Camber Spine Technologies and Renovis Surgical Technologies

FDA (510)k Clearance Awarded to 3D Printed Medical Implants from Camber Spine Technologies and Renovis Surgical Technologies

Following in the recent footsteps of SI-BONE’s iFuse-3D Implant and Cellular Titanium spinal implants by EIT, two more medical device companies have announced this week that they have received the all-important (510)k clearance from the US Food and Drug Administration (FDA) for 3D printed titanium spinal implants. This stamp of approval is increasingly important, especially as 3D […]

Following in the recent footsteps of SI-BONE’s iFuse-3D Implant and Cellular Titanium spinal implants by EIT, two more medical device companies have announced this week that they have received the all-important (510)k clearance from the US Food and Drug...
First 3D Printed Titanium Implant for the Sacroiliac Joint, the iFuse-3D Implant, Gets FDA Clearance

First 3D Printed Titanium Implant for the Sacroiliac Joint, the iFuse-3D Implant, Gets FDA Clearance

Titanium has been used to 3D print all sorts of items, like hearing aids and airplane parts, and even a Garmin cycle mount, but the metal is really making a difference in the medical field. We’ve seen 3D printed titanium vertebrae, spinal interbody devices, and every type of titanium implant you can imagine, from hip implants and jaw […]

Titanium has been used to 3D print all sorts of items, like hearing aids and airplane parts, and even a Garmin cycle mount, but the metal is really making a difference in the medical field. We’ve seen 3D printed titanium vertebrae, spinal interbody devices, and...
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...
K2M Group Expands 3D Printed Spinal Solutions Portfolio Following FDA Clearance for CASCADIA Titanium Systems

K2M Group Expands 3D Printed Spinal Solutions Portfolio Following FDA Clearance for CASCADIA Titanium Systems

For most, magic is in the air from the moment you unpack that 3D printer, unveiling what is usually an elegant looking machine that acts as the bearer of many things good—allowing us to act on concepts and designs like never before, whether engaged in making modern jewelry, household goods, car parts, or so many other areas as the […]

For most, magic is in the air from the moment you unpack that 3D printer, unveiling what is usually an elegant looking machine that acts as the bearer of many things good—allowing us to act on concepts and designs like never before, whether engaged in making modern...
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....
3D Printing: The Stories We Didn’t Cover This Week — March 12

3D Printing: The Stories We Didn’t Cover This Week — March 12

In this week’s 3D printing news, we see that change is in the air — as always. Shapeways has just added a new coating that will make your 3D scanned and printed selfies look even better, and Stratasys Asia Pacific has appointed a new General Manager to focus on its China operations. Over at Materialise, there’s been a big […]

In this week’s 3D printing news, we see that change is in the air — as always. Shapeways has just added a new coating that will make your 3D scanned and printed selfies look even better, and Stratasys Asia Pacific has appointed a new General Manager to...
Editor’s Choice: 15 of the Coolest 3D Printing Stories of 2015

Editor’s Choice: 15 of the Coolest 3D Printing Stories of 2015

2015 has been quite a year. Personally, I’ve loved it; I got married, bought a house, hit a milestone birthday, and became editor-in-chief of this great site. I’m almost sad to see 2015 winding down (only a few hours left!) but I’m hopeful that the momentum that this year has provided will propel 2016 right […]

2015 has been quite a year. Personally, I’ve loved it; I got married, bought a house, hit a milestone birthday, and became editor-in-chief of this great site. I’m almost sad to see 2015 winding down (only a few hours left!) but I’m hopeful that 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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