Medical Devices

News & Analysis as of

Arm’s Length Royalty Rates Save Medtronic from $1.36 Billion Tax Deficiency

Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more

California Federal Court Dismisses Inferior Complaint

Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean: the spider-like creatures with small centers, from which long, bent legs emanate in all directions. That is sort of what IVC...more

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

FDA Approves Medtronic Prestige LP Cervical Disc for 2-Level Use

The FDA recently approved the Medtronic Prestige LP Cervical System for treating degenerative disc disease at two adjacent vertebral levels (between C3 and C7). The device is said to be Medtronic’s third clinically-proven...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more

CMS Hosts Call on Potential Future Changes to Open Payments/Sunshine Act Reporting Requirements (Aug. 2)

On August 2, 2016, CMS is hosting a Special Open Door Forum Call on potential future changes to Open Payments/Physician Payments Sunshine Act requirements for reporting payments and transfers of value made by drug and device...more

CardiAQ’s Inventorship Challenge Survives

Neovasc began its business relationship with CardiAQ in June, 2009, by providing services and supplies for the development of CardiAQ’s TMVI heart valve device. Though the relationship lasted only 10 months, the parties...more

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical...

On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more

Wearable Medical Devices Market Trending Upwards

New reports, such as the Global Diagnostic Wearable Medical Devices Market 2016-2020 Report, bring good news to the rapidly growing wearable medical device market. According to the Report, the diagnostic wearable medical...more

FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests

On July 14, 2016, the U.S. Food and Drug Administration (the “FDA”) released draft guidance on the codevelopment of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the...more

First Extended-Range Intraocular Lens Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tecnis Symfony Intraocular Lenses (IOL) for treating cataracts. According to Abbott, the Tecnis Symfony lenses are currently the only lenses in the United...more

Sixth Circuit Affirms FNC in Favor of Germany

We’ve mentioned before how our Trusts & Estates professor described the German legal system as “the mind of God revealed to man.” Professor Langbein was especially impressed with the German system of training judges, as well...more

FDA Deep Dive: Real Life Implications of FDA NEST Program Explored

In our Israel Connect Summer 2016 edition we summarized the FDA’s post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally...more

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

CMS Proposes Update to Medicare OPPS, ASC Rates and Policies for 2017

CMS has published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for CY 2017. CMS proposes a 1.55%...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

European Life Sciences Review: Issue 3

Welcome to the third issue of our European Life Sciences Review that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

FDA Approves First MRI-Guided Ultrasound Device to Treat Essential Tremor

The FDA recently approved INSIGHTEC’s Premarket Approval (“PMA”) application for ExAblate Neuro, a device designed to treat essential tremor. Essential tremor is the most common kind of tremor; it commonly affects the hands,...more

Women’s Health Litigation Conference

No television show gives its viewers more than Game of Thrones – more characters, more plot-lines, more sex, more violence, and more magic. The enormous production values scream from the screen. The frame cannot quite...more

New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies...more

It’s Just Too Much

We’ve blogged before about the long-running appeal in the Polett v. Public Communications litigation. That’s the case where the plaintiff had knee implant surgery that was so successful she agreed to make a promotional video...more

Import of raw materials and components for manufacturing of medical devices exempted from VAT

Federal Law No. 225-FZ on Amendments to Part Two of the Tax Code of the Russian Federation dated 30 June 2016 enters into force on 1 August 2016. According to the law, a VAT exemption is granted on import of raw materials and...more

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should...more

1,188 Results
|
View per page
Page: of 48
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×