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 part of its deregulatory initiative on July 1, the federal Occupational Safety and Health Administration proposed deleting requirements for medical evaluations before employees are permitted to use certain classes of...more
As more employers incorporate wearable technology in the workplace, including those enhanced by artificial intelligence, the Equal Employment Opportunity Commission (EEOC)’s new fact sheet “Wearables in the Workplace: The Use...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 revokes...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. ...more
Manufacturers of activity trackers and smartwatches have been fighting over the “serious” healthcare market for several years. Companies such as Apple (previously discussed here), Fitbit (previously discussed here), and...more
This summary is intended to help clients navigate the large number of legal measures taken expeditiously by the Russian authorities in connection with the spread of COVID-19. The summary is not exhaustive. It includes only...more
The US Nuclear Regulatory Commission (NRC) issued a letter on April 27 to the Nuclear Energy Institute and the National Organization of Test, Research, and Training Reactors, and others, clarifying and expanding the guidance...more
Employers are facing issues relating to shortages of respirators and non-surgical face coverings. The ever-evolving local, state, and federal regulatory landscape, coupled with these shortages, has sent employers scrambling,...more
In response to growing medical product supply shortages and need for information, the US Food and Drug Administration (FDA) has recently issued multiple enforcement policies to provide guidance to industry. Here, we focus on...more
On April 3, 2020, OSHA issued enforcement guidance that temporarily permits the extended and re-use of respirators as well as other alternatives, and clarifies when respirators, including N95 masks, may continue to be used...more
As recently as March 27, the WHO was stating on its website that there was insufficient evidence to suggest that the novel coronavirus was airborne except in a handful of medical cases, such as when intubating an infected...more
To combat shortages of N95 respirators, the Centers for Disease Control and Prevention issued and continues to update its Strategies for Optimizing the Supply of N95 Respirators. The CDC’s N95 Respirator Strategies provide...more
As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for...more
Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices. In this new Guidance, the FDA says it is expanding “the availability and capability of sterilizers, disinfectant...more
To address the increased usage and shortages of respirators as a result of combatting COVID-19, on 24 March 2020 the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for non-NIOSH approved...more
On March 22, 2020, the U.S. Food and Drug Administration (FDA) published guidance that relieves manufacturers of FDA-cleared ventilator products of the requirement to submit a premarket notification (510(k)) prior to making...more
Late action by the Senate to pass a second COVID-19 relief package (that the White House soon signed) may [key word may] help markets yo-yo back upward today after a dismal Wednesday driven by crazy-low oil prices (West Texas...more
Seyfarth Synopsis: Employers are widely installing AEDs to protect employees and visitors, but some states require strict compliance with AED regulations to insulate employers form tort liability....more