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3D Printing FDA Approval

Knobbe Martens

FDA Approves LimaCorporate’s 3D-Printed Reverse Shoulder Replacement System

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The FDA recently approved LimaCorporate’s fully 3D-printed glenoid baseplate and humeral stem for use in reverse shoulder replacement....more

Benesch

3D Printing Half-Year Report - Q2 2021

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Is 3D printing the next litigation frontier? Litigation over 3D printing will become increasingly more prevalent as the technology becomes less expensive to build due to rising demand, some lawyers say. A federal court in...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Guidance on Use of 3D Printing on Medical Devices, Accessories, Components, and Parts

On March 26, 2020, the U.S. Food and Drug Administration (FDA) issued guidance surrounding the use of 3D printing on medical devices, accessories, components, and parts during the COVID-19 pandemic....more

Seyfarth Shaw LLP

FDA Emergency Use Authorizations (“EUA”) for COVID-19: What is an EUA and What is Currently Covered?

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Starting in February 2020, the US Food and Drug Administration (the “FDA”) began using its Emergency Use Authorization (“EUA”) powers under Section 564 of the Federal Food, Drug, and Cosmetic Act (“FD&C”) to allow unapproved...more

Knobbe Martens

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

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3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D...more

Knobbe Martens

China FDA Issues Guidance on 3D Printed Medical Devices

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More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking...more

Knobbe Martens

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

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On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio,...more

Benesch

3D Printing and the Renaissance of Local Economies

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The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

Benesch

2015 End-Of-Year Wrap-Up

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On November 19, 2015, Benesch’s 3D printing group quarterbacked a well-attended presentation sponsored by the Association for Corporate Growth-Cleveland. In addition to Mark Avsec from Benesch (and Ira Kaplan’s...more

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