Medical Devices

News & Analysis as of

An Error-free Seventh Circuit Medical Device Case

Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers. Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what...more

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Cardinal Health to Acquire Cordis for $2 Billion

(March 2, 2015) Johnson & Johnson announced that Cardinal Health has made a binding offer to acquire Cordis, a Johnson & Johnson company, for $1.99 billion. The press release indicates that the sale price includes $1.944...more

Paragon Medical Announces Acquisition of Michael Bubolz GmbH

Paragon Medical recently announced its acquisition of Michael Bubolz GmbH. The acquisition terms were not disclosed. According to the press release, Michael Bubolz, which is headquartered in Germany and has a facility in...more

Four Mile Bay Sues Zimmer Holdings

Four Mile Bay, LLC recently sued Zimmer Holdings, Inc. in the United States District Court for the Northern District of Indiana. The complaint alleges that Zimmer Holdings’ hip implants, such as the “Trabecular Metal Primary...more

The Apparently Never-Ending Story of Bard v. W.L. Gore - Bard Peripheral Vascular Inc. and C.R. Bard, Inc. v. W.L. Gore &...

In a case centered about patent that matured from an application filed 40 years ago, a case that has been pending for 12 years and that just completed its fourth engagement at the appellate level, the U.S. Court of Appeals...more

Olympus Sued Over “Superbug” Infections

The New York Times recently reported that 179 patients at the UCLA Ronald Reagan Medical Center were exposed to a potentially deadly “superbug” between October of 2014 and January of 2015. As of February 18, the infection of...more

Medical Device Market to Reach $361 Billion

According to an article in Medical Design Technology, Kalorama Information’s 2014 report on The Global Market for Medical Devices estimated that the global market for medical devices was expected to reach $361 billion by...more

Scanadu: the Medical Tricorder from Star Trek

For those familiar with the television show Star Trek, many may remember the Tricorder, a device that Dr. “Bones” McCoy used to wirelessly scan a patient to assess the individual’s medical status. The California...more

Ways and Means Committee to Markup Medicare Fraud, Competitive Bidding, and other Medicare Policy Bills

On February 26, 2015, the House Ways and Means Committee is scheduled to vote on the following bills: H.R. 1021, “Protecting the Integrity of Medicare Act of 2015” – a sweeping bill to promote Medicare program...more

Combinations of Predictable Elements from the Prior Art Need Not Be Advantageous - Nuvasive, Inc. v. Warsaw Orthopedic, Inc.

Addressing the propriety of combining prior art in an obviousness analysis, U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (“PTAB” or “Board”) determined that a patent for a spinal implant for...more

GAO Evaluates CMS Activities to Prepare Health Industry for ICD-10 Launch

According to a recent GAO report, CMS has taken numerous steps to prepare industry for the October 1, 2015 transition to ICD-10 codes, such as developing checklists, timelines, and other educational materials and hosting...more

ProNerve Holdings, LLC, A Colorado Based Provider of Intraoperative Neurophysiologic Monitoring (IOM) Files for Chapter 11...

On February 24, 2015, ProNerve Holdings, LLC and 8 affiliated companies filed voluntary chapter 11 petitions in Delaware. The case is docketed at 15-10373, and has been assigned to The Honorable Kevin J. Carey....more

FDA Releases Planning Board's Report on National Medical Device Postmarket Surveillance System

FDA has released the Medical Device Postmarket Surveillance System Planning Board’s report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, which outlines recommended steps...more

23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

Final Decision in NuVasive’s Inter Partes Review of Warsaw Orthopedic Patent

The Patent Trial and Appeals Board (the “Board”) recently issued Final Written Decisions disposing of two inter partes reviews that NuVasive filed in mid-2013 regarding U.S. patent number 8,444,696 (the ’696 Patent). The ’696...more

Spineology Sues Wright Medical Technology

Spineology, Inc. sued Wright Medical Technology, Inc. (Wright Medical) in the United States District Court for the District of Minnesota . Spineology’s complaint alleges that Wright Medical’s X-REAM percutaneous expandable...more

Clinical Trial and Medicare Provider Quality Improvement Provisions in House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“Committee”) released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting...more

Go For De Novo: FDA’s Revised Approach to Medical Device Accessories

Accessories are an everyday reality for almost all users of technology products today.  They can help improve efficacy, increase usability and make many other improvements to the technology we use.  Increasingly, accessories...more

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

Device Manufacturer Settles False Claims Act Allegations with DOJ for $1.25 Million

The Department of Justice (DOJ) recently announced that ev3 Inc. (which acquired Fox Hollow Technologies, Inc. (“Fox Hollow”), a medical device manufacturer, in late 2007) agreed to pay $1.25 million to resolve allegations...more

Is vaginal mesh safe to use?

Vaginal mesh is commonly used for the treatment of pelvic organ prolapse (POP), a condition where an organ drops from its normal place in the lower belly and pushes against the walls of the vagina. Another common use for the...more

GPhA Annual Meeting 2015: GDUFA, Quality, and Industry Trends – Part Two of Two

Day Two of the open GPhA Annual Meeting featured a panel on FDA and industry perspectives on a quality culture. Janet Woodcock, M.D., Center Director, Center for Drug Evaluation and Research (CDER) provided the agency’s new...more

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