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
The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and...more
Recently, my colleague Amy Foust made some really good points about a subject that is rarely discussed. Over the years, a number of patients have claimed that they were injured by surgical robots defective by design or...more
FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. ...more
The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand,...more
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential...more
On July 15, 2014, FDA issued draft guidance Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. We think of it as a...more
Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more
Within the last week the Food and Drug Administration (FDA) issued a pair of Safety Communications directed towards the medical device and healthcare industries regarding cybersecurity. Computer virus and other malware...more
The Joint Commission (TJC) recently published a Sentinel Event Alert (Alert) regarding “alarm fatigue,” which occurs when physicians are so overwhelmed by the constant barrage of medical device alarms, most of which do not...more
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more