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
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 Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...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
Following the election in February, the party leaderships of CDU, CSU and SPD have agreed on a coalition agreement titled “Responsibility for Germany”. The 146-page document also sets out aspects regarding the healthcare and...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more
In order to comply with the provisions of the EU Medical Device Regulation (EU MDR) and the (coming) Spanish MDR, the Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicinal Products and Medical...more
On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products before access to reimbursement by the public health insurance...more
On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform....more
In Tuesday's Report: FDA lists essential medicines and medical countermeasures, Trump plans health official replacement, FDA expands remote monitoring exemption list, WHO director self-quarantines, and other U.S. White House...more
Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more
Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more
Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more