Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
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
The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more
On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more
I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more
In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more