510(K) clearance
3D Printing News Briefs, November 18, 2023: Depowdering, Jewelry Patterns, & More
We’re kicking off 3D Printing News Briefs with a little business today, as Horizon Microtechnologies invested in a micro AM platform from Boston Micro Fabrication, and Rivelin Robotics announced a…
3D Printing News Unpeeled: 3D Systems Base Resin, ArcelorMittal Enters Powder Market and the NIOSH
The US´s National Institute for Occupational Safety and Health (NIOSH) has released a set of guidelines for using 3D printing called, ¨Approaches to safe 3D printing: a guide for makerspace…
Carbon & Desktop Health Partner for FDA-approved Dental 3D Printing
Taking a significant stride in digital dentistry, Desktop Health and Carbon have inked a new partnership. By integrating the groundbreaking Flexcera family of resins by Desktop Health with Carbon’s digital manufacturing…
Totally Tubular: Desktop Health’s 3D-Bioplotter Now 3D Prints Tube-shaped Medical Devices
Desktop Health, the medical 3D printing division of Desktop Metal (NYSE: DM), has unveiled a new tool called PrintRoll. This first-of-its-kind bioprinting tool is an attachment for their 3D printer…
LuxCreo Gets FDA Class II 510(k) Clearance for Direct 3D Printed Dental Aligners
Dental aligners made through thermoforming based on 3D printed inserts are one of the biggest additive manufacturing (AM) applications in the world. Pioneered by Align and now used by Smile…
Desktop Health’s SmileGuard Dental 3D Printing Resin Receives Full FDA 510(k) Clearance
Desktop Health, a business within the Desktop Metal umbrella, has recently announced that its SmileGuard light-curable biocompatible resin has received full U.S. Food and Drug Administration (FDA) 510(k) clearance. The…
FDA 510(k) Clearance for 3D LifePrints
3D LifePrints‘ Cranio-Maxillofacial surgical planning product, EmbedMed, has received FDA 510(k) clearance. An ISO 13485-certified cloud tool, EmbedMed gives clinicians access to the entire workflow needed to convert DICOM or…
3D Printed Pelvic Implants from Onkos Surgical Earn FDA Clearance
The medical field is, rightly so, a highly regulated one, and you can’t really get momentum for a product until it’s received clearance from the U.S. Food and Drug Administration…
FDA Clears Ricoh Healthcare Solution to 3D Print Personalized Anatomical Models
Japan-based multinational Ricoh revealed that its RICOH 3D for Healthcare solution, which integrates with IBM iConnect Access from IBM Watson Health to fabricate 3D printed anatomic models, has received 510(k)…
3D Printing Financials: 3D Systems Adjusts 2022 Guidance Range After Mixed Q1 Earnings Results
For a while, it seemed companies worldwide were recovering from a two-year hiatus due to the pandemic. But then 2022 turned out to be another year of uncertainties, driven primarily…
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…
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…
