Medical Devices

News & Analysis as of

Federal Circuit Issues an Opinion in 40 year Dispute over “Gore-Tex” Blood Vessel Graft Patent

(January 13, 2015)  The United States Court of Appeals for the Federal Circuit affirmed a lower court’s finding that W.L. Gore & Associates, Inc. (“Gore”) willfully infringed U.S. Patent No. 6,436,135 (“the ’135 patent”) . ...more

FDA Policy On Wellness Products Is Healthy For Industry

On Jan. 16, 2015, the U.S. Food and Drug Administration promulgated a much-anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest attempt...more

Medical Device Update: FDA Releases General Wellness Products and Device Accessories Guidance Documents

Background - On January 20, 2015, the U.S. Food and Drug Administration (FDA or the Agency) announced the availability of two draft guidance documents in the Federal Register: “General Wellness: Policy for Low Risk...more

Life Sciences and Health Care Industries Reap the Benefits of 3-D Printing

The past few years have seen 3-D printing – a process that involves the creation of a three-dimensional object from a pre-conceived design – evolve from a futuristic idea into a multi-billion dollar business, and few...more

Regulating a Healthy Lifestyle? FDA Distributes New Draft Guidance on “General Wellness Products”

On January 16, 2015, the Food and Drug Administration (FDA) promulgated a much - anticipated draft guidance concerning the classification and regulation of general wellness products. The draft guidance is the FDA’s latest...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

"Insights Conversations: Life Sciences"

A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more

FDA Issues Guidance for Low-Risk General Wellness Products

On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles (so-called “general wellness products”) direction on when such products qualify as...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

Federal Circuit Upholds $35 million Infringement Award to KFx Medical

(January 20, 2015) KFx Medical Corp.‘s $35 million patent infringement award against Arthrex, Inc. was upheld by the Federal Circuit. KFx’s lawsuit alleged that Arthrex’s SutureBridge and SpeedBridge devices infringed U.S....more

CMS Announces DMEPOS/Home Health/Hospice RAC, Improvements to RAC Process

CMS has announced that it has awarded the Region 5 Recovery Audit contract to Connolly, LLC (although the General Accounting Office subsequently reported that a bid protest has been filed regarding this award). The purpose of...more

Bills to Repeal Medical Device Excise Tax Introduced

Congressman Erik Paulsen (R., Minn.) and Senator Orrin Hatch (R., Utah) recently introduced bills H.R. 160 and S.149, respectively. Both bills are part of an effort to repeal the 2.3% excise tax on medical device...more

Can Digital Healthcare Innovation Be Patented? Eligibility of Digital Healthcare Technologies Under the New USPTO Eligibility...

Digital healthcare, the confluence of digital technology with medical and other biological fields, has become an ever-increasing presence in our daily lives. Ideas that seemed nearly impossible just a few years ago (such as...more

Third Ethicon Bellwether Trial Set for March 2015

Judge Goodwin is presiding over seven different federal multidistrict litigation established for similar cases filed against various medical device manufacturers, including American Medical Systems, Boston Scientific,...more

FDA Proposes Additional Flexibility for Mobile Health Products

Draft Guidances Address General Wellness Products and Device Accessories - The U.S. Food and Drug Administration (FDA or “the Agency”) has announced two more key parameters of its regulatory approach to mobile health...more

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. ...more

Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time.  The Yale University Open Data Access (“YODA”)...more

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

Nothin’ from Nothin’ Leaves Nothin’

Axiom Worldwide Inc. v. Excite Medical Corp. et al. - The U.S. Court of Appeals for the Eleventh Circuit affirmed a district court’s $1.32 million judgment in favor of a medical device maker, ruling that it never owned...more

The verdict is clear: diffusion tensor imaging demonstrates damage to the brain associated with mild traumatic brain injury

The weight of scientific evidence demonstrates that “diffusion tensor imaging” is an effective tool for demonstrating damage to the white matter of the brain associated with mild traumatic brain injury. The damage...more

Florida Federal Court Retains Jurisdiction Over Knee Implant Case

Debra Kilmer filed suit against Stryker Corporation, Stryker Sales Corporation and Howmedica Osteonics Corporation (“Defendants”), asserting that she had been injured by a defective knee implanted in her in Florida state...more

SCENIHR Publishes Final Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical...

On January 13, 2015, the European Commission (EC) and its Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the final opinion “Guidance on the Determination of Potential Health Effects of...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Texas Jury in The First Pinnacle Hip Trial Returns a Verdict for the Defense

This is what a common hip prosthesis looks like. The Pinnacle has a metal cup instead of a polyethylene (plastic) cup. In 2009, Kathleen Herlihy-Paoli was implanted with a metal-on-metal Pinnacle hip....more

Punitive Damages Claims May Proceed Against Boston Scientific

Several plaintiffs that were implanted with Boston Scientific’s Obtryx transobturator Mid-Urethral Sling System alleged in their lawsuits that the manufacturer, Boston Scientific, ignored warning that devices containing...more

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