AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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