Work This Way: An Employment Law Video Podcast | Episode 51: Smarter Recruiting Strategies with Rhiannon Poore of Forge Search
CMO Series Live Special: The AI Revolution and What it Means for CMOs
What Is Ambient AI and Why Does It Matter to Lawyers & Legal Professionals?
The Authenticity Advantage: How Runbin Dong’s Scale Social AI Helps Small Businesses Shine
Key Discovery Points: A Judicial Approach to Handling AI-Generated Evidence
Richard Meneghello of Fisher Phillips on How Smart Content Can Set Your Firm Apart - Passle's CMO Series EP175
Feeling Disillusioned with AI? You’re Not Alone
Daily Compliance News: June 26, 2025, The? Matt Galvin Honored Edition
Great Women in Compliance: GWIC X EC Q2 2025 - Exploring Compliance Innovations
Daily Compliance News: June 25, 2025, The PCAOB Elimination Hits Roadblock Edition
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
Upping Your Game: Crowd - Sourcing Risk Management Intelligence with AI
Daily Compliance News: June 24, 2025, The Questions, Questions, and More Questions Edition
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
#Risk New York Speaker Series – Bridging the Gap: Effective Risk Communication in Compliance with Rob Clark, Jr.
#Risk New York Speaker Series – Upping Your Game with Tom Fox
SBR-Author’s Podcast: Upping Your (Compliance) Game
Innovation in Compliance: Real-Time Fraud Prevention Strategies for Financial Loss Prevention with Vince Walden
Risk New York Speaker Series: AI Investments and Political Uncertainty with Chris Mason
Episode 373 -- Christian Focacci on Current Developments in AI and Risk Management
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more
Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an...more
Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more
On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more
On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more
The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more
Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more
If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP)...more
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more
On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more
ADA Advocating for Fluoridation, Says Medical Devices Should Not Be Subjected to Tariffs - The dental industry and DSOs are experiencing change as both continue to embrace technology, including AI. The political and...more
Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more
Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more