News & Analysis as of

Medical Devices 3D Printing

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Knobbe Martens

Recent Developments in Medical Casts

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On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin.  Cast21’s device seeks...more

Faegre Drinker Biddle & Reath LLP

Why 3D Printing Doesn’t Have to be a Pandora’s Box for IP Rights

Personal 3D printing has seen leaps in advancement in recent years, allowing users to render increasingly sophisticated creations from the comfort of their own home. These creations can include anything from gaming miniatures...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 3, March 2023

Amazon Sued for Not Telling New York Store Customers about Tracking Biometrics - “Thanks to a 2021 law, New York is the only major American city to require businesses to post signs letting customers know they’re tracking...more

K&L Gates LLP

Health Care Triage: Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

K&L Gates LLP on

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more

Knobbe Martens

Osteoconductive Filament Developed for 3D Printed Implants

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Evonik is a specialty chemical company developing biomaterials that serve as metal-free alternatives to traditional bone implants. Evonik’s VESTAKEEP product line includes an osteoconductive polyether ether ketone (PEEK) – a...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Comments Prior to Regulating 3D Printing of Medical Devices at the Point of Care

Medical device companies have for many years used 3D printing to create innovative products such as custom patient-matched devices and individualized anatomical models for surgical planning. Typically, these activities have...more

Foley & Lardner LLP

3D Printing Medical Devices at the Point of Care — FDA Invites Feedback

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care. Amidst COVID-19...more

Smart & Biggar

New CADTH Report on Health Technology Trends in 2021

Smart & Biggar on

The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more

Dechert LLP

fintech NEXT: Developments on Digital Assets and Blockchain

Dechert LLP on

Blockchain technology continues to mature and gain acceptance for a wide range of potentially disruptive financial and commercial uses. In the wake of COVID-19, we have seen an increased focus on the research and development...more

Sheppard Mullin Richter & Hampton LLP

3D-Printed Masks, Disinfecting Devices, and Simplified Ventilators – a Sampling of Tech Advances in the Age of COVID-19 from...

The current COVID-19 environment has disrupted standard operations in nearly every industry and created fertile grounds for innovation. This is the first of a series of blog posts that will look at how industries have enabled...more

Nelson Mullins Riley & Scarborough LLP

COVID-19 Pandemic Highlights Consumer Product Safety, Compliance Issues in 3D Printing

An unprecedented demand for critical medical products in recent weeks has triggered an urgent interest in the potential of 3D printing to create personal protective equipment (PPE) and other medical devices during the...more

BakerHostetler

Considerations for 3D Printing of Medical Devices, Accessories, Components and Parts During the COVID-19 Pandemic

BakerHostetler on

The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more

Shook, Hardy & Bacon L.L.P.

COVID-19: Will 3-D Printing Medical Supplies and Protective Products Expose You to Liability?

Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world....more

Cadwalader, Wickersham & Taft LLP

COVID-19 Update: When Computers Invent: How the Use of Artificial Intelligence to Treat COVID-19 Highlights Novel Inventorship...

Technology and medical companies around the world are rising to meet the challenges created by the COVID-19 pandemic, in many cases turning to artificial intelligence (“AI”) and super computers in their efforts to develop...more

Hogan Lovells

COVID-19 and emergency inventions

Hogan Lovells on

As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...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?

Seyfarth Shaw LLP on

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

McDermott Will & Emery

FDA Issues FAQs on 3D Printing of Medical Devices, Accessories, Components and Parts During the COVID-19 Pandemic

On March 26, 2020, the US Food and Drug Administration issued FAQs on 3D printing of medical devices, accessories, components and parts during the Coronavirus (COVID-19) pandemic. While the use of 3D printers can help address...more

Orrick, Herrington & Sutcliffe LLP

COVID19 IP Update: Can 3D Printing Be the Solution to the Medical Supply Shortage?

As the pandemic worsens, more and more hospitals and medical providers are experiencing shortfalls of critical supplies, including ventilators, face shields, and masks. Those with 3D printers and idle manufacturing centers...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 4, 2019

Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more

White and Williams LLP

“Magic Arms”: The Future of 3D Printing and Its Impact on Healthcare

White and Williams LLP on

In the past, doctors and researchers were limited in the types of individualized devices they could create for their patients; now, 3D printing presents the possibility of creating almost any device, limited only by their...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

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