News & Analysis as of

Medical Devices

DOJ Places Website Rulemaking on the “Inactive” List

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Trump Administration’s first Unified Agenda reveals DOJ has placed web accessibility, medical equipment, and furniture rulemakings under Title II and III of the ADA on Inactive List....more

AGG Food and Drug Newsletter - July 2017

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

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Philips Acquires EGI

by Knobbe Martens on

Philips recently announced that it will purchase Electrical Geodesics, Inc. (EGI). The total value of the deal is estimated to be GBP 29.0 million (approximately $36.9 million). According to its website, EGI designs,...more

MRI-Compatible Robot Aims to Improve Breast Cancer Biopsies

by Knobbe Martens on

The University of Twente in Enschede, Netherlands recently introduced “the world’s smallest and most accurate 3D-printed biopsy robot,” called the Stormram 4. The device is designed to carry out biopsies during breast cancer...more

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

by Faegre Baker Daniels on

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

by Cozen O'Connor on

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case

by Reed Smith on

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and...more

Philips Acquires Spectranetics for $2.16 Billion

by Knobbe Martens on

According to a June 28, 2017 press release, Dutch healthcare company Philips has agreed to buy Colorado Springs-based Spectranetics Corporation, a cardiac device manufacturer, for approximately 1.9 billion euros ($2.16...more

AGs Weave Themselves Into Patchwork of Digital-Health Regs

by Pepper Hamilton LLP on

There are more than 165,000 mobile health applications available for download in Apple’s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

FDA Adds Additional Premarket Notification 510(k) Submission Requirements for Certain Reusable Medical Devices

by Arnall Golden Gregory LLP on

The 21st Century Cures Act included a provision requiring the Food and Drug Administration (FDA) to publish a notice in the Federal Register identifying a list of reusable devices that will be required to include validated...more

Blog: Off-Label Use Gets Congressional Hearing

by Cooley LLP on

Today, the House Energy and Commerce Committee will hold a hearing tilted “Examining Medical Product Manufacturer Communications.” According to the Committee, the focus of the hearing will be how the Food and Drug...more

Activity Trackers Eye Inactivity Tracking

by Knobbe Martens on

Fitbit recently announced plans to build sleep apnea diagnostics into its wrist-worn activity tracking devices, stating that it expects do so within a year.  If successful, Fitbit may be able to address a market that is...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

A Double Whammy for California Design Defect Claims

by Reed Smith on

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue. Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803...more

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

Eleventh Circuit Gets It Wrong on Preemption

by Reed Smith on

We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot...more

EU Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746, Pharmaceutical & Medical Device Update, Vol....

by Jones Day on

Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more

Relocation of the European Medicines Agency – France shows EMA its smooth moves

by Hogan Lovells on

With Brexit under way, the European Medicines Agency is looking for a new home. France revealed itself as a serious contender when it considered offering not just one hosting place for the Agency, but five! Up until recently,...more

Blog: Maine Enacts Gift Ban Law

by Cooley LLP on

Yesterday, An Act To Prohibit Certain Gifts to Health Care Practitioners became law in Maine without the signature of the Governor. 32 MRSA § 13759 prohibits licensed pharmaceutical and medical device manufacturers and...more

Washington, D.C. Update – June 2017

by Baker Donelson on

Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

ITC Issues Public Commission Opinion Clarifying Methodology for Allocating Domestic Industry Expenses and Issuing Exclusion Order...

On May 17, 2017, the International Trade Commission (ITC) reversed an ALJ’s ruling and found a violation of Section 337 in Certain Air Mattress Systems, Components Thereof and Methods of using the Same (“Certain Air Mattress...more

Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

by Reed Smith on

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

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