HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
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
The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
California is rolling out two climate disclosure laws—SB 253 and SB 261—that will soon require major companies that operate in California to publicly report their greenhouse gas (GHG) emissions and climate-related financial...more
On August 6, 2025, the Federal Trade Commission (“FTC”) filed a motion for preliminary injunction to block Edwards Lifesciences Corporation’s (“Edwards”) $945 million proposed acquisition of JenaValve Technology, Inc....more
On July 31, 2025, the United States Department of Justice (DOJ) announced a $9.8 million settlement with Illumina, Inc. (Illumina) to resolve alleged False Claims Act (FCA) violations related to cybersecurity vulnerabilities...more
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more
Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual Summit for Women Leaders in Life Sciences Law. This conference is a highlight for us every...more
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
On July 31, 2025, the U.S. Department of Justice announced that Illumina Inc. agreed to pay $9.8 million to resolve False Claims Act (“FCA”) allegations concerning cybersecurity deficiencies in its genomic sequencing systems...more
- What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies. - Why it...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
On July 18, 2025, the U.S. Court of Appeals for the Federal Circuit reversed a $106 million jury verdict in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No. 2023-2153, finding that Colibri’s infringement claim under...more
Despite continued macroeconomic headwinds and a cautious investment climate, Mintz’s Venture Capital and Emerging Companies practice remained highly active throughout 2024 and into the first half of 2025. Our team advised on...more
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more
On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA....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
Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more
The Riverside Company has announced it has sold The Marena Group to CenterGate Capital....more
In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more
What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How have Medicare inpatient volumes changed over time for inpatient hip and femur...more