Category Archives: FDA

Centinel Spine 3D printed implant achieves FDA approval

Additive manufacturing continues to aid in the production of medical-grade implants. From 3D printed cages built to support the spine to the development of biocompatible facial implants, 3D printed implants have displayed its functionalities over traditional medical procedures. Taking a step further to improve spinal treatments, Centinel Spine, a Pennsylvania-based spinal device development company, has […]

Centinel Spine erhält FDA Genehmigung für FLX-Plattform

Centinel Spine erhält FGenehmigung für FLX Plattform 281x300 - Centinel Spine erhält FDA Genehmigung für FLX-Plattform

Centinel Spine, ein führendes Unternehmen zur Wirbelsäulen-Rekonstruktion mit Hilfe von 3D-Drucktechnologien, erlangte nun eine Genehmigung der FDA zur Vermarktung dessen FLX-Plattform für Wirbelsäulen-Implantate. Das Wirbelsäulen-Unternehmen Centinel Spine entstand ursprünglich aus einer Fusion der zwei Unternehmen Raymedica und Surgicraft. Beide dieser Unternehmen beschäftigten sich mit der Entwicklung von Operationstechniken sowie Implantaten zur Linderung von Wirbelsäulenerkrankungen. Heute [...]

Der Beitrag Centinel Spine erhält FDA Genehmigung für FLX-Plattform erschien zuerst auf 3Druck.com – Das Magazin für 3D-Drucktechnologien.

Australia reviews regulation of personalized and 3D printed medical devices

Australia’s Therapeutic Goods Administration (TGA) has collated the public’s responses to proposed regulatory changes for personalized and 3D printed medical devices. Overall, the consensus has been that the proposal needs “more clarity,” and the body, therefore, is putting a halt to regulatory development for 3D printed perosnalized medical devices in favor of seeking “Further stakeholder […]

China FDA calls for professional guidance on 3D printed medical devices

As the self-made manufacturing capitol of the world, China is a country to look to for 3D printing’s ascension into the supply chain. Though a recent report stated “It is still too early to conclude that the mass production era has been replaced by the mass customisation era,” the State has made formal efforts to increase […]

3D printed microneedles present pain-free alternative to syringes

With an FFF 3D printer researchers at the University of Texas at Dallas (UT Dallas) now have a new low-cost method of making microneedle arrays – a small syringe-alternative patch for administering drugs. The method combines a commercially available desktop 3D printer with a chemical etching technique. It enables the creation of ultra-fine microscopic pins in a […]

FMI Instrumed increases metal additive manufacturing for medical devices capacity

FMI Instrumed has added a fifth industrial metal 3D printer to their Schiedam facility in the Netherlands. FMI Instrumed is a subsidiary of FMI, a machining company first established in 1962. FMI operates a number of metal 3D printers, including the Concept Laser M2 Cusing Dual Laser additive manufacturing system. The powder bed fusion M2 […]

Interview: Carbon cuts through the hype with new FDA approved dental materials

Carbon’s new 3D printable DENTCA resins have been released with approval from the FDA. As materials for dentistry, DENTCA Denture Base II and DENTCA Denture Teeth resins, are subject to an exception in FDA certification that typically would not pass certification on 3D printer materials. In this interview with Steven Pollack, Senior Staff Research Scientist at Carbon, 3D […]

FDA clears “first ever” 3D printed spine implant to treat of multiple injuries

Metal additive manufacturing has hit on a clear niche within the healthcare industry for producing small and complex medical grade implants at scale. Many 3D printing companies working within medicine have a portfolio of devices for the purpose, typically including a sample of 3D printed cages used to support the spine. However, in what is […]

FDA Richtlinien für 3D-gedruckte Medizienprodukte

Die amerikanische Behörde FDA (Food and Drug Administration) hat Richtlinien für 3D-gedruckte Medizinprodukte herausgegeben. Diese sind noch nicht bindend, könnten aber ein erster Schritt für eine gesetzliche Regulation von 3D-gedruckten Medizinprodukten darstellen. 3D-gedruckte Medizinprodukte sind ein äußerst aktuelles Thema in der Medizin. Daher ist es wenig überraschend das sich die FDA mit der Thematik befasst. […]

Der Beitrag erschien bei 3Druck.com unter der URL FDA Richtlinien für 3D-gedruckte Medizienprodukte

HCA contract means EIT 3D printed medical devices will be available at largest GPO in US

Emerging Implant Technologies GmbH (EIT), a German medical 3D printing enterprise, has announced an important contract with the largest group purchasing organization (GPO) in the United States. Working with Ortho Sales Partners, EIT has successfully concluded the contracting process with HealthTrust related to an HCA contract. The Hospital Corporation of America (HCA) has 177 hospitals […]