News & Analysis as of

Medical Devices

Jury Awards $10.4 Million in Damages to Philips for ZOLL’s Infringement of Defibrillator Patents

by Knobbe Martens on

Patent Judgments and Awards - On August 3, 2017, a Boston jury awarded Philips $10.4 million in damages for ZOLL’s infringement of three patents relating to automated external defibrillators. This represents only a...more

Anti-Corruption Risks and Drug and Device Companies

by Michael Volkov on

For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Thank You Very Much, Mr. Roboto: FDA Announces New Digital Health Programs

by Arnall Golden Gregory LLP on

Scott Gottlieb, M.D., FDA's commissioner, recently announced new digital health initiatives that will aid in the agency's push to regulate and support digital healthcare in the medical device space. In a statement posted to...more

Causation Testimony Excluded in Heart-Lung Bypass Machine Death Case – Again

by Reed Smith on

Not even three weeks ago, back on July 28, we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district...more

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

by Knobbe Martens on

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

FDA Announces Import Staffing Change at International Mail Facilities

Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more

FDA’s Health Software PreCert program to fast-track innovation

by Thompson Coburn LLP on

Digital information has taken over our day-to-day lives, and the federal Food and Drug Administration (FDA) continues to recognize that this includes many aspects of our health care as well. This is clearly demonstrated by...more

FDA Announces Digital Health Innovation Action Plan to Implement 21st Century Cures Act

by Morgan Lewis on

Agency also launches voluntary pilot program as first step in developing software pre-certification program....more

Siemens Medical Equipment Vulnerable to Cyber-Attacks

The Department of Homeland Security and Siemens Healthineers has identified cybervulnerabilities in the Windows 7-based versions of Siemens PET/CT systems, SPECT systems, SPECT/CT Systems and SPECT Workplaces/Symbia.net and...more

Embrace™ Neonatal MRI Device Gains FDA Clearance

by Knobbe Martens on

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more

Healthcare Industry May Not Be Prepared For Internet of Things

by Knobbe Martens on

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT...more

FDA’s Software Pre-Cert Program: More Details Revealed

by Hogan Lovells on

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

FDA User Fee Reauthorization Legislation Enacted by Congress

by Ropes & Gray LLP on

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate followed suit by passing FDARA without amendment by a vote of 94-1. The President...more

EMA envisage to link development of companion diagnostics and personalised medicines

by Hogan Lovells on

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface...more

August 2017 Is Here – Will FDARA Get Done Soon?

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act...more

Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership

by Hogan Lovells on

Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more

Comment K and Non-Implanted Medical Devices

by Reed Smith on

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of...more

New FDA Digital Health Program

by Holland & Knight LLP on

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more

US Food and Drug Administration’s New Digital Health Innovation Action Plan Details a Software Precertification Pilot Program

by McDermott Will & Emery on

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more

How Not To Create an “Exception” to the Learned Intermediary Rule

by Reed Smith on

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers. But while it’s illegal for anybody working for the U.S. government to accept...more

House Advances Bipartisan FDA User Fee Agreements; Senate Faces Narrow Timeline to Act

by Baker Donelson on

On July 12, the House passed a five-year reauthorization of four different user fee agreements that account for over a quarter of the Food and Drug Administration's (FDA) overall funding. The legislation, titled "The Food and...more

The Rule of Law is the Best Medicine, Part 2

by Reed Smith on

Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.” PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...more

Advertising requirements relating to medical devices in South Africa

by Dentons on

In this article, we provide a brief overview of the requirements for the advertisement of medical devices in South Africa....more

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