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Lawmakers’ Silly Season No Laughing Matter for Device Industry

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Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should ex

Use the Charts for New Conversations

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In my March 7, 2012, column, “An Elegantly Simple but Counterintuitive Approach to Analysi

FDA Budget Could Hike User Fees, Overseas Inspections

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Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the 

Breaking Into Major Markets for Medical Device Manufacturers

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The global demand for medical devices has been steady in traditional markets despite the economic downturn and even increasing in some emerging markets.

New Medical Device Standard Puts Health Care at Risk

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One of the greatest challenges that I have in discussing standards is trying to put things in a context so that all people affected by them can understand how they matter. So I want to start with a simple picture and a remarkable snapshot in time.

Providers and Patients Unsettled with Health Care Changes

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Industry experts at Guidon Performance Solutions’ Second Annual Virtual Healthcare Summit agreed that health care organizations’ ability to survive their increasingly demanding and changing environment will require a new agility and adaptability.

Wireless, Self-Propelled Medical Device ‘Swims’ Through Bloodstream

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For 50 years, scientists searched for the secret to making tiny implantable devices that could travel through the bloodstream. Engineers at Stanford University have demonstrated just such a device.

Workplace Health Care Is a Growing Trend

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In an era of soaring medical costs, providing health care to employees at or near their workplace is gaining new momentum, according to an article in the Winter 2012 issue of MIT Sloan Management Review.

Turning the Third Edition of IEC 60601-1 to Your Advantage

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There are substantial changes in the third edition of IEC 60601-1, and understanding all aspects of them is the key to turning the standard into a benefit for medical-device manufacturers.

Misguided FDA Food Regulations Will Hike Costs, Not Safety

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This year will mark another push for aggressive food regulation at the Food and Drug Administration (FDA). On tap, salt regulations and industrywide regulations dictating which foods can be advertised on television.

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