News & Analysis as of

Medical Devices

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Fall/Winter 2018

Interview with Dr. Daniel Burnett of Theranova LLC - Wilson Sonsini Goodrich & Rosati partner James Huie recently interviewed Dr. Daniel Burnett, president and CEO of TheraNova. TheraNova is an experienced medical device...more

Searcy Denney Scarola Barnhart & Shipley

Firefighter Awarded $1.2 Million Due to IVC Filter Injuries

Due to a failure to warn doctors and patients of the complications of IVC filter usage, Houston firefighter Jeffrey Pavlock was awarded $1.2 million in a jury verdict against Cook Medical after experiencing blood vessel and...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for August 2018?

by Morrison & Foerster LLP on

This month we highlight a district court opinion from Judge Dyk, sitting by designation, denying a preliminary injunction in a brand-vs-brand litigation, and a lengthy district court opinion from Judge Bryson, sitting by...more

Knobbe Martens

CardiAQ - An IP Success Story

by Knobbe Martens on

At the recent ACC-Socal Double Header Event, Knobbe Martens presented, "CardiAQ - An IP Success Story." Please see full Presentation below for more information....more

Alston & Bird

Alston & Bird Healthcare Week in Review

by Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

Searcy Denney Scarola Barnhart & Shipley

Incest and the FDA — Is the FDA Really a Watch Dog?

Drug Manufacturing is Big Business - The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to...more

Hogan Lovells

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

by Hogan Lovells on

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

Pillsbury - Policyholder Pulse blog

Electing to Pay One Claim Over Another to an Insured’s Detriment Could Subject Insurers to Bad Faith Claims

A federal court in Michigan just breathed new life into a long-running legal saga—while at the same time issuing a warning shot across the bows of insurers—by declining to dismiss an insured’s bad faith cause of action...more

Kelley Drye & Warren LLP

Eggs-ageration: Goop Settles With California District Attorneys Over Misleading Health Claims

by Kelley Drye & Warren LLP on

The California Food, Drug, and Medical Device Task Force announced a settlement this week with Goop, the lifestyle brand founded by Gwyneth Paltrow, which we’ve written about here and here. The complaint alleges that Goop...more

Ruder Ware

OIG Opinion on Donation of Telehealth Equipment

by Ruder Ware on

A recent Advisory Opinion (Advisory Opinion 18-03) from the Office of Inspector General (OIG) of the Department of Health and Human Services addresses potential kickback issues involved in the donation of telehealth...more

Hogan Lovells

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

by Hogan Lovells on

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more

Mintz - Intellectual Property Viewpoints

Not just for crypto – How blockchain technology will affect medical devices

Most people are familiar with blockchain technology because of its use in cryptocurrency, but its use is going to be far more widespread than just as a ledger for digital currency. As explained in a previous blog post,...more

Hogan Lovells

Italy: Parallel imports – When a name change is a game changer.

by Hogan Lovells on

The Administrative Court of Lazio (“TAR Lazio”) decided with judgment No. 09050 of 3 July 2018 (but published only few days ago) that, as a rule, the parallel importer does not have a right to change the trademark affixed on...more

King & Spalding

Cybersecurity Vulnerabilities Found In New Medical Devices

by King & Spalding on

Critical security flaws have been discovered in two widely-used medical devices, according to a disclosure by the IT consulting firm CyberMDX. Working closely with the device manufacturers, CyberMDX found vulnerabilities in...more

Knobbe Martens

Boston Scientific Buys Venous-Stent Maker VENITI

by Knobbe Martens on

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug...more

Poyner Spruill LLP

Securing Wireless Infusion Pumps in Healthcare

by Poyner Spruill LLP on

The National Cybersecurity Center of Excellence (NCCoE) announced in August that it has finalized the draft guidance it first issued in May of last year on securing wireless infusion pumps. Infusion pumps are often tasked...more

Arnall Golden Gregory LLP

AGG Food and Drug Newsletter - August 2018

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Arnall Golden Gregory LLP

FDA Allows Off-label Communications to Payors, Formulary Committees, and Similar Entities. What’s Next?

by Arnall Golden Gregory LLP on

In June, FDA issued two final guidance documents on medical product communications for drug and device manufacturers. The first guidance concerns “Medical Product Communications That Are Consistent With the FDA-Required...more

Hogan Lovells

UK publishes "no deal" guidance for medicines and medical devices

by Hogan Lovells on

The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed post-Brexit...more

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

by Hogan Lovells on

On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

Pepper Hamilton LLP

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

by Pepper Hamilton LLP on

A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Stinson Leonard Street

FDA Permits Quarterly Summary Reporting for Certain Medical Device Malfunctions

by Stinson Leonard Street on

Medical device reporting for manufacturers of Class I and Class II devices that are not implantable/life-sustaining/life supporting (I/LS/LS) may have just gotten easier....more

Morgan Lewis

Medical Device Exports to Iran After Resumption of Sanctions

by Morgan Lewis on

After the decision to terminate US participation in the Joint Comprehensive Plan of Action, most EAR99 medical devices remain covered by general licenses for export or re-export to Iran, but medical device companies will need...more

Knobbe Martens

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

by Knobbe Martens on

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac...more

Searcy Denney Scarola Barnhart & Shipley

Smith & Nephew SMF Hip System and REDAPT Recall Lawyers

Searcy Denney is representing clients who have been implanted with the Short Modular Femoral Hip System and Modular REDAPT from Smith & Nephew in lawsuits alleging that the manufacturer failed to warn them of the risks...more

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

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Updates to This Policy

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