News and Insights of 3D Printing and Manufacturing
Desktop Health, recently launched by Desktop Metal, has received U.S. Food and Drug Administration (FDA) 510(k) clearance of FlexceraTM Base, a proprietary resin for use in 3D fabrication of high-quality dental prosthetics. Flexcera Base along with the new FlexceraTM Smile are Desktop Health’s first formulated and optimized digital dental solutions.
Additive manufacturing has been touted for its potential to have a major role in disrupting the traditional orthopedic industry for almost a decade. However, even in a sector that grapples with increasing costs for orthopedic specialists and demands for improved comfort, aesthetics, and quality of life, adoption of AM technologies has been slow. Much of it has to do with costs and quality of materials as well as the productivity rate of the machines. This is now changing as material giant BASF’s Forward AM is partnering with Belgian MedTech company Spentys to make these supports truly available, accessible, and viable.
restor3d merger with Kinos Medical, an expert total ankle replacement company. restor3d was founded with a mission to enable surgeons to repair and reconstruct the human body using 3D printing technologies, advanced biomaterials, and artificial intelligence. In 2018, the company invested in significant infrastructure and in-house manufacturing capabilities to expand its offering of implants in orthopedic and spine indications. With a robust pipeline of products slated for regulatory submission, recent FDA clearances include osteotomy wedges and cervical interbody fusion implants. The merger with Kinos Medical will accelerate restor3d’s expansion into the high-growth foot and ankle market in the U.S.
Desktop Health, a service recently launched by Desktop Metal, received the Conformité Européenne (CE) Mark certification for its Flexcera resin, a proprietary technology for use in 3D fabrication of high-quality dental prosthetics. The CE Mark affirms that Flexcera resins meet the requirements of the European Medical Devices Directive, paving the way for Desktop Health to launch Flexcera resins to dental professionals within the European Union (EU) and other CE Mark geographies. Flexcera Base, which recently received U.S. Food and Drug Administration (FDA), and Flexcera Smile are Desktop Health’s first formulated and optimized digital dental solutions.
BellaSeno GmbH, an ISO 13485-certified MedTech company developing absorbable scaffolds using additive manufacturing technologies, established a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany.
FluidForm, an expert in the field of human tissue for research, repair, and replacement signed an agreement with Ethicon, a member of the Johnson & Johnson Medical Devices Companies, to develop 3D bioprinted applications using FluidForm’s patented FRESH technology. This collaboration leverages FluidForm’s FRESH 3D bioprinting platform to achieve specific tissue characteristics that cannot be manufactured with conventional techniques.
Researchers at the UK-based Staffordshire University have developed an ultra-low-cost insole with integrated sensing capabilities that could help prevent the growth of life-threatening foot ulcers in diabetics.
The capabilities of a 3DUJ-553 3D printer from Mimaki, a manufacturer of wide-format inkjet printers and cutters, have been leveraged by the University of Florence and Mimaki’s exclusive Italian importer Bompan to produce 3D printed anatomical models with a previously unattainable degree of color fidelity.
Munich-based chemical firm Linde Group and clinical printing specialist 3D Medlab have announced the results of testing their new process gas to optimize the 3D printing of medical components.
Biotechnology specialist Pixelbio has developed a novel 3D printed molecular biochip with the potential to ramp-up the pace of clinical genetic testing.