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 Rhode Island Medical Spas Safety Act (RI MSSA) was signed into law by Governor Daniel McKee on June 30, 2025, and is the latest example of the increasing regulation of medical spas. Despite their growth in popularity...more
State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing...more
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
On April 29, 2024, the U.S. Department of Commerce officially published a final rule in the Federal Register that formally incorporates a medical device license exception into the Export Administration Regulations (“EAR”) for...more
License Exception MED - On April 25, 2024, the Department of Commerce’s Bureau of Industry and Security (“BIS”) announced a final rule for a new license exception for “medical devices” under § 740.23 of the EAR (“License...more
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
On May 4, 2023, Montana changed its product liability laws when the Governor signed SB 216, which was effective upon passage and applies to claims that accrue on or after May 4, 2023. Among the changes is the adoption of a...more
US Nuclear Regulatory Commission (NRC) regulations at 10 CFR 20.1703(c)(5)(iii) and 10 CFR 20.1703(c)(6) require licensees to maintain a respiratory protection program that requires (1) a periodic—often annual—determination...more
House overrides minimum wage veto - On a vote of 100-49, the House voted to override Gov. Phil Scott’s veto of the minimum wage bill. The bill will raise the state’s minimum wage to $11.75 in 2021, and $12.55 in 2022, and...more
Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more
International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the...more
The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more
Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more
Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog...more