Category Archives: Food and Drug Administration

Materialise greenlights Ultimaker S5 for medical 3D printing

Dutch 3D printer manufacturer, Ultimaker, has announced that the Ultimaker S5 FDM/FFF printer has received Materialise certification. Materialise tested the compatibility of the Ultimaker S5 for FDA approved medical applications using the Materialise Mimics inPrint software.  John Kawola, President of Ultimaker, North America, said, “The Materialise certification of the 3D printing workflow when used with Mimics […]

FDA awards $2.6M in grants for 3D bioprinting and biomedical research

The U.S Food and Drug Administration (FDA) has awarded grants to five research institutes for the study and improvement of biomanufacturing, including 3D bioprinting. Scott Gottlieb, MD, FDA Commissioner, said, “Advanced manufacturing technologies, such as continuous manufacturing, hold great promise for improvements in the reliability, flexibility, and cost-effectiveness of manufacturing for biological products.” “we awarded […]

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 Though a recent report stated “It is still too early to conclude that the mass production era has been replaced by the mass customisation era,” the State has made formal efforts to increase […]

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 unter der URL FDA Richtlinien für 3D-gedruckte Medizienprodukte

FDA makes statement concerning the future of 3D printing in medicine

The increasing availability of 3D printed medical devices, like hip implants or cranial plates, and the potential benefits of 3D printed drugs, makes additive manufacturing in healthcare hard to ignore. Committed to assuring the safety of such products, the FDA has been keeping a watchful eye on the technology’s progress, both internally and through the […]