Medical Devices

News & Analysis as of

CMS To Publish Financial Relationships Between Physicians and Drug Manufacturers Beginning September 2014

Beginning in September 2014, the Centers for Medicare and Medicaid Services (“CMS”) will publish a list of all payments and transfers of value paid by drug manufacturers to physicians and teaching hospitals on a publicly...more

China Overhauls Regulation on the Medical Device Industry

The Chinese Central Government recently adopted material amendments to the Regulation on the Supervision and Administration of Medical Devices, which will bring significant changes for medical device companies operating in...more

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Edwards Secures Preliminary Injunction Against Medtronic

On April 11, 2014, according to a press release, the U.S. District Court for the District of Delaware issued a preliminary injunction barring Medtronic, Inc. from selling its CoreValve TAVI product to most new customers in...more

Dallas Woman Awarded $1.2 Million, Mesh Called Defectively Designed

For the first time, a Texas jury has decided the pelvic mesh made by healthcare giant Johnson & Johnson was defectively designed. The jury awarded the 64-year-old Dallas woman $1.2 million following a two-and-a half week...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The regulation of cosmetic interventions in the UK: toothless rhetoric or industry overhaul?

This Reed Smith client alert looks at the UK government’s response to the independent review of the regulation of cosmetic interventions in the UK. The key issues In recent years, cosmetic procedures have become widely...more

Supreme Court Ruling On Asset Forfeiture — Assumes Guilt Until Defendants Prove Their Innocence

Kerri and Brian Kaley were investigated for stealing medical devices and laundering money they earned from sale of the stolen property. The Kaleys arranged for an equity loan to pay for their defense counsel. ...more

Real OFAC Policy Changes Toward Iran—OFAC will consider non Ag/Med exports

As a new round of nuclear talks involving American, European, and Iranian leaders commence this week in Vienna it appears that the first-step deal agreed upon in January has already led to significant changes in OFAC’ s...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

Newest Published Literature Latest to Slam Stryker Rejuvenate Failures

Recently published literature in the Journal of Bone and Joint Surgery draws the conclusion that the short-term, high rate of corrosion-related revision with Rejuvenate modular neck implants is “striking.”...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

FDA Reports Rise in Medical Device Recalls and Warnings

This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division...more

Harvard Researchers Take FDA Approval of Implantable Cardiac Devices to Task

Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to...more

TVM Update: $1.2M Awarded in Batiste v. Ethicon

The trial in the case of Linda Batiste v. Ethicon came to fruition on April 3, 2014 when a jury awarded Batiste $1.2 Million in compensatory damages. The verdict ended a two and a half week trial that began on March 17, 2014...more

Intuitive Surgical Sued by Shareholders Over Withheld Complications

Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci....more

TVM Update: Coloplast in talks to Settle for $16 Million

Transvaginal mesh maker Coloplast A/S (In Re: Coloplast Corp Pelvic Support System Products Liability Litigation, 12-md-2387, U.S. District Court, Southern District of West Virginia) is said to be in talks to settle a basket...more

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

Best Practices For Laser-Assisted Cataract Surgery

A femtosecond (FS) laser is exciting new technology, but it requires consideration of some important governance and compliance issues. Best practices require the surgeon and the facility (ASC or Hospital) to identify covered...more

Patent fundamentals for researchers, manufacturers

Patent laws function much the same way no matter the technology at issue. But there are some aspects of patent law that affect particular industries in specific ways. My Thompson Coburn colleague Steve Ritchey looked at some...more

China Introduces Major Changes to Medical Device Regulations

On March 31, 2014, China’s State Council released the amended Regulations on the Supervision and Administration of Medical Devices (the “Regulations”), effective as of June 1, 2014. A series of implementing rules are expected...more

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