News & Analysis as of

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

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).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

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

Medgadget Lists 2014's Best Medical Technologies

Medgadget has come out with its list of the best medical technologies of 2014. They are as follows: - 1. Flexible Microelectronics...more

Trends in N.J. Whistleblowing and Retaliation Law – 2014 Roundup

2014 was another busy year for developments in whistleblowing and retaliation law in New Jersey. This blog post summarizes noteworthy state and federal cases for employers to consider in the new year....more

OSHA: Kinesiology Tape is “Medical Treatment” for Recordkeeping Purposes

You have probably seen kinesiology tape, also known as KT Tape or Kinesio Tape: those bright, neon-colored tape strips worn by runners, cyclists, athletes, triathletes, and folks at the gym. In a December 12 letter of...more

Growing Safety Risk for Hospitals: Spiraling Medical Device Recalls

Everyone knows that the number of medical device recalls is on the rise. Here are two telling examples of the growth. In 2003 a total of 604 recalls were reported to the FDA, while last August a single manufacturer recalled...more

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste. On Halloween of 2014,...more

Florida High Court to Decide Duties Owed by Public School Regarding Automated External Defibrillator

On October 6, 2014, the Florida Supreme Court heard oral argument in a case involving whether a public school owes a duty to maintain, make available, and use an automated external defibrillator (AED) on a student athlete who...more

Butterfly Network Launches With Over $100M in Financing to Make Handheld Medical-Imaging Device

Butterfly Network, Inc. announced on November 3rd that it has raised over $100 million to commercialize a medical device designed to reduce the cost of real-time, three-dimensional imaging and treatment. Butterfly states that...more

D.C. Circuit Rejects FDA’s Claim of Inherent Authority to Reclassify a Device by Rescinding a 510(k) Substantial Equivalence Order

On September 26, 2014, the D.C. Circuit issued an opinion holding that the Food and Drug Administration (“FDA”) failed to follow the appropriate statutory procedure for reclassifying a device when the Agency relied on its...more

Certifications Under the Trade Agreements Act: 10 Tips to Avoid TAA Traps for the Unwary

On September 3, 2014, U.K.-based medical device maker Smith & Nephew (the ‘‘Company’’) agreed to pay $8.3 million (plus an additional $3 million in attorney’s fees) to resolve a lawsuit filed under the federal civil False...more

FDA Releases Final Cybersecurity Guidance for Medical Devices

Overview and General Principles - On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

Health Update - September 2014

Engaging Patients While Addressing Their Privacy Concerns: The Experience of Project HealthDesign - Patients are using the Internet, personal health records (PHRs) and mobile applications or “apps” to collect and...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

Medical Device Manufacturer Settles Trade Agreements Act Suit

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

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