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
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more
n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
Too many of us don’t enjoy life to the fullest because our health is lagging. In fact, the federal Centers for Disease Control and Prevention estimates that 6 in 10 U.S. adults have a chronic disease and 4 in 10 have two...more
Le PLFSS 2024 sanctionne les fabricants de dispositifs médicaux "polluants" Le Gouvernement poursuit sa volonté d’opérer la transition écologique à travers deux mesures introduites à l’article 29 du PLFSS 2024 dont l’une va...more
Companies marketing 'polluting' medical devices will be penalised under the French Social Security Financing Bill for 2024. The French Government continues its desire to implement ecological transition through measures...more
FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
Noise and light can be bad for us just like dirty water and air - The picture-perfect spot to live our healthiest lives would be temperate, with fresh air, sparkling water, and night skies ablaze with stars. It would...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle Advisory Program (“TAP”) Pilot. The first phase...more
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary...more
For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products....more
Report on Patient Privacy 22, no. 9 (September, 2022) - More than 92% of patients believe privacy is a right and their health data should not be available for purchase, according to a survey from the American Medical...more
The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more
The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more
L'arrêté ministériel fixant la Charte relative à la qualité des pratiques professionnelles de présentation, d'information ou de publicité des dispositifs médicaux à usage individuel, des autres produits de santé et de tout...more
The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices for individual use, other health products and any associated...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more