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
China has imposed restrictions on procurement of European medical devices, following the European Union’s vote to limit Chinese companies from participating in public procurement tenders for medical device contracts last...more
Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
China imposed new restrictions on the eligibility of certain medical devices originating from the EU in government procurement activities effective July 6, 2025. New restrictions do not apply to EU companies participating in...more
Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...more
Adopted in 2022, the IPI allows the Commission to investigate alleged non-EU country measures or practices against EU economic operators that limit access to the public procurement and concession markets of non-EU countries....more
Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...more
On June 19, 2025, the European Commission (“EU Commission”) adopted Regulation 2025/1197 imposing restrictive measures on Chinese medical devices in its first use of the European Union’s International Procurement Instrument...more
The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more
The European Commission has launched its first investigation into a non-EU country's procurement practices leveraging its new tool, the International Procurement Instrument. This investigation looks at the public procurement...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression against Ukraine, and cyber threats. It does not purport to provide an...more
In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more