510(K) clearance

3D Printed Patient-Specific Cancer Treatment Bolus Added to 3D Systems Portfolio

As part of their treatment regime, about 50% of cancer patients will undergo radiotherapy, which kills the cancer cells using a focused beam outside of the body or placing radioactive…

Desktop Health Unveils New 3D Printer Series to Strengthen Dental Portfolio

Desktop Health, the recently launched healthcare business within Desktop Metal, Inc. (NYSE: DM), works to create 3D printing solutions for multiple areas of personalized medicine. This includes a focus on…

3D Printed Bone to Be Driven by A.D.A.M. Crowdfunding Campaign

Targeting the $50 billion orthopedic implant market, biotech startup A.D.A.M. (short for Advanced Development of Additive Manufacturing) launched an equity crowdfunding campaign on StartEngine that has so far accumulated $122,298…

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…

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Desktop Health Receives FDA Clearance for Denture 3D Printing Material

Desktop Metal’s (NYSE: DM) recently launched medical division, Desktop Health, has just earned its first major pedigree as a new business unit: FDA clearance. Desktop Health’s proprietary resin, Flexcera Base,…

A.D.A.M. Seeks Investors for Bone 3D Printing

We recently reported on what appears to be financial woes at Ukrainian 3D printing startup, Kwambio. According to a Ukrainian site, AIN.UA, the company acknowledged some difficulties in terms of…

3D Printing News Briefs, October 18, 2020: Sigma Labs & INS.OS, Raise3D, PrinterPrezz

In this week’s 3D Printing News Briefs, we’re talking about a strategic alliance, a software launch, and FDA clearance. Sigma Labs and IN4.OS are teaming up for Factories of the…

FDA Says A.D.A.M.’s 3D Printed Bones are Eligible for 510(k) Clearance

As the healthcare industry increasingly welcomes and adopts the use of 3D printing, and other technology solutions such as AI and big data, it’s helping to improve some long-standing issues,…

3D Systems Announces 510(k) Clearance for MF Surgical Guide 3D Printing Materials

A veritable pioneer in 3D printing for personalized medicine applications, 3D Systems (NYSE:DDD) created its Virtual Surgical Planning (VSP) system for craniomaxillofacial (CMF) and orthopaedic cases years ago, and it’s…

3D Printing News Briefs: November 12, 209

In today’s 3D Printing News Briefs, we’re talking a little business, then moving on to some medical news. Volkswagen has achieved a major metal 3D printing milestone with HP, and…

Nexxt Spine Receives FDA 510(k) Clearance for 3D Printed Stand Alone Cervical Implants

Medical device company Nexxt Spine, founded in Indiana ten years ago, manufactures its own product line of spinal implants and instrumentation. This month, the company announced that its NEXXT MATRIXX Stand Alone…

Captiva Spine Receives FDA Clearance for 3D Printed Titanium Lumbar Cages

3D printing has been playing a big role in helping people with spinal conditions over the last few years, particularly in terms of implants and other medical devices. But none…

3D Printing News Briefs: June 29, 2018

In today’s 3D Printing News Briefs (the last one this month, how is the summer going by so quickly?!), a few companies are announcing special honors and recognitions, and then…

Centinel Spine Receives FDA Approval for 3D Printed Spinal Implants

This year, Centinel Spine celebrates its 10th anniversary, but the company’s work has been going on for much longer than a decade. Centinel was formed from the merger-acquisition of two…

Zimmer Biomet’s First 3D Printed Spinal Implants Receive FDA Clearance

It’s not easy to get a new medical treatment or device to the market – and it shouldn’t be, as these treatments are affecting human lives and need to be…

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…

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….

3D Printing News Briefs: January 12, 2018

We’ve got some 3D printing business and medical news to start things off in today’s 3D Printing News Briefs, followed by some interesting projects featuring 3D printing. Additive Industries has…

3D Printed PEKK Structures Shown to Offer Superior Antibacterial Properties for Orthopedic Implants in Comparison Study with PEEK

Connecticut-based Oxford Performance Materials, Inc. (OPM) first commercialized its proprietary OsteoFab process back in 2013; two years later, the company received 510(k) clearance from the FDA for its 3D printed…

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…

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…

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…

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…