Category Archives: FDA

FDA vergibt Fördergelder an Universitäten für Bioproduktionsforschung

Bioprinting 300x216 - FDA vergibt Fördergelder an Universitäten für Bioproduktionsforschung

Die FDA hat fünf Forschungsinstitute für die Erforschung und Verbesserung von Bioproduktion, einschließlich 3D-Bioprinting, ausgezeichnet. „Fortschrittliche Fertigungstechnologien wie die kontinuierliche Fertigung sind vielversprechend für die Verbesserung der Zuverlässigkeit, Flexibilität und Kosteneffizienz der Herstellung von biologischen Produkten“, sagte FDA-Kommissar Scott Gottlieb in der Pressemitteilung. „Diese Plattformen könnten entscheidend dazu beitragen, das volle Potenzial neuartiger Technologien wie [...]

Der Beitrag FDA vergibt Fördergelder an Universitäten für Bioproduktionsforschung erschien zuerst auf 3Druck.com – Das Magazin für 3D-Drucktechnologien.

OPM to establish 3D printed medical device operations in Asia

High performance additive manufacturing (HPAM) and material science company Oxford Performance Materials (OPM) has partnered with advanced material supplier JSR Corporation in Tokyo to launch medical & dental operations across Asia. Under the new partnership, JSR has an exclusive regional license to provide and distribute OPM’s PEKK based 3D printing services and consumables. The two entities will operate […]

Clinicians use 3D printed breast phantoms for safer and faster cancer diagnosis methods

Researchers from the U.S. Food and Drug Administration (FDA) in Maryland have developed a new 3D printing software tool that aids in the creation of patient-specific 3D printed breast phantoms. Breast phantoms are frequently used in place of breast tissue as test beds for mammography devices to ensure optimized breast cancer detection and treatment. Cancer […]

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 […]