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Washington Healthcare Update

This Week: Senate HELP Committee Hosts Hearing on Medical Innovation... HHS Announces Next Generation Accountable Care Organization (ACO) Model... CBO Releases New Long-range Cost Estimates for ACA....more

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

FDA Issues Guidances for Medical Device-Related Apps and Systems

The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for ”Data Systems and Imaging Devices” issued on February 9, 2015, and...more

Health Care Update - March 2015

In This Issue: - King v. Burwell before the Supreme Court and the Potential Congressional Response - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional...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Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate.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

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

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

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Proposed FDA Overhaul to Improve Biomedical Discovery and Development

The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act. The reforms are aimed at accelerating the approval of new drugs, medical devices and other products regulated...more

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

FDA Will Not Enforce Regulatory Controls for Medical Device Data Systems and Two Other Health IT Devices

In a move certain to please developers of health information technology (IT) products, on February 6, 2015, the U.S. Food and Drug Administration (FDA) posted final guidance announcing its intent to exercise enforcement...more

What your doctor may not be telling you about inferior vena cava filters

Patients who are at high risk for developing blood clots are regularly given inferior vena cava filters in Chicago hospitals and around the nation. While the filters have been used for years in this application, recent...more

First Flexible Tip Ablation Catheter To Receive FDA Approval

St. Jude Medical, Inc. recently announced that the U.S. Food and Drug Administration (FDA) has approved its FlexAbility Ablation Catheter for use by electrophysiologists to treat cardiac arrhythmia....more

FDA Issues Draft Guidance That Affects Health IT

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

The Cure for the Common FDA Reform Legislation? House Committee Releases 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee (“E&C Committee”) released a long-awaited discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative....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

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

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

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