fda approval

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…

EIT’s 3D Printed Cellular Titanium Spinal Implants Receive FDA Clearance

3D printing has brought advancements to the medical industry across the board, but one area that has been especially affected is the treatment of spinal conditions. 3D printing has allowed…

FDA Approval for E-Denture Means EnvisionTEC Now Enables Dentists and Labs to 3D Print Full Denture Solutions

You may have given up on the ‘what will they be 3D printing next’ line. At this point, it seems few items or industries have been left untouched by the…

3D Printing News Briefs: June 20, 2017

In 3D Printing News Briefs today, we’re covering 3D printers and 3D printing pens, materials, software, business, and…the nuclear future of the Philippines? Mosaic Manufacturing launches the multi-material Palette+, while Ilios…

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…

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…

Medicrea Files for FDA Clearance for 3D Printed Titanium Spinal Interbody Devices

In the medical field, getting a new product, whether it be a drug, a device, or a surgical technique, to market is a long, drawn-out process that can take years….

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…

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…

3D Technology Allows MEDICREA to Create New FDA-Approved Spinal Implants Giving Patients Dramatic Relief

The excitement surrounding the 3D printing industry, resulting in countless mind-boggling innovations, is an energy and a source of endless wonder that we have the privilege of immersing ourselves in every…

Aprecia’s 3D Printed Epilepsy Drug is Finally Commercially Available

Getting a new medication to the market is not a fast or easy process, no matter how promising the drug is. There’s the research and development phase, testing, more testing,…

Zimmer Biomet Receives FDA Clearance for 3D Printed Ankle Fusion System

There’s so much that can go wrong with the joints – particularly the ones that carry our weight. The knees and ankles are strong but delicate at the same time,…

3D Printed Titanium Cranial/Craniofacial Implant from BioArchitects Approved by FDA

A facial injury or deformity is one of the most traumatizing things that can happen to a person. There’s the inevitable social stigma, the discomfort with being in public, but…

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…

China Food & Drug Administration Approves 3D Printed Hip Implants for Use

Early last month, we reported on a groundbreaking story in which the FDA had officially approved the first 3D printed drug. The ZipDose tablets were designed to make administering the drug…