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fda

Leading the Charge: How Eli Lilly is Revolutionizing Medicine and Manufacturing

Charles R. Goulding and Preeti Sulibhavi highlight Eli Lilly’s remarkable growth and groundbreaking advancements in pharmaceuticals, from Alzheimer’s treatment to innovative 3D printing drug delivery.

BMF’s UltraThineer Earns FDA Clearance for Cosmetic Veneers

Boston Micro Fabrication has received an important approval for a new material.

3D Systems Achieves 510(k) Clearance for PEEK Cranial Implants

The FDA has approved the 3D printed, patient-specific VSP PEEK Cranial Implant solution.

3D Printing’s Role in Custom-Fit Hearing Aids and Dementia Risk Reduction

Charles R. Goulding and Preeti Sulibhavi discuss how companies in the medtech industry can leverage 3D printing to enhance customization and fit of hearing aids.

3D Printing in Medicine: Philips’ Partnerships with 3D Systems and Stratasys

Charles R. Goulding and Preeti Sulibhavi remark on Philips’ transformation into a healthcare-focused company how its engagement in 3D printing activities can help.

Navigating Regulatory Challenges: Ricoh’s Journey in 3D Healthcare Printing

Ricoh seems to have found a promising niche in the 3D print world: anatomical models.

FDA Approves Over-the-Counter Hearing Aids and 3D Printing Can Help

Charles R. Goulding and Preeti Sulibhavi look at the potential for use of 3D printing to produce hearing aids on demand.

DyeMansion’s VaporFuse Process Breaks the Food Barrier

DyeMansion’s VaporFuse Process Breaks the Food Barrier

DyeMansion announced a new food safe capability for their VaporFuse process, and several corporate advancements.

President Biden’s Executive Order To Improve Hearing Aid Availability And 3D Printing

President Biden’s Executive Order To Improve Hearing Aid Availability And 3D Printing

Charles R. Goulding and Arianna Coger listen to ways 3D printing continues to innovate in hearing aid production.

Where You Can Find Certified COVID-19 3D Models

The US FDA has been engaged with other parties to assist in the use of community 3D printing resources to confront the COVID-19 crisis.

Published July 7, 2020
Categorized as models Tagged America Makes, certification, covid-19, fda, models, nih, nih 3dpx, repository

Materialise Enlightens Medical Care With FDA-Approved Cardiovascular Software

Materialise has received FDA clearance for its cardiovascular planning software.

Published June 17, 2019
Categorized as Software Tagged fda, materialise, medical, medical. usage, software

FDA Awards Grants to Bioprinting Institutions

Charles Goulding and Rafaella July of R&D Tax Savers explore the US FDA’s grants forwarding work in bioprinting.

Published December 27, 2018
Categorized as research Tagged bioprinting, fda, R&D, research

Materialise Mimics inPrint Certification Program Clears Ultimaker and Formlabs for Medical 3D Printing

Materialise’s announcement today of FDA-cleared medical model 3D printing encompasses vat polymerization and material extrusion technologies in addition to PolyJet.

Published November 26, 2018
Categorized as coverage Tagged @formlabs, @ultimaker, collaboration, fda, materialise, medical

FDA-Cleared Medical 3D Printing with Stratasys and Materialise

3D printing medical models offers benefits to patients and those providing their care with highly accurate patient-specific anatomies able to be held, examined, and practiced on.

Published November 26, 2018
Categorized as coverage Tagged fda, materialise, medical, model, multicolor, multimaterial, stratasys

What is a 510(k) Clearance and Why do 3D Print Companies Need it?

Occasionally I will see companies announce they’ve received a “501(k) clearance”. What is that and why is it important? 

Published April 20, 2017
Categorized as Corporate Tagged approval, fda, medical
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